[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychological-distress\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychological-distress":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,69,0,25,[9,46,77,101,139,172,209,235,255,280,313,336,367,384,407,438,457,485,511,535,560,589,610,628,651],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100565151","clinical-trial-for-acupuncture-in-adolescents-with-psychological-distress-and-insomnia-100565151",false,"NCT06638450","Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia","Dense Cranial Electroacupuncture Stimulation Plus Body Acupuncture for Adolescents With Psychological Distress: a Randomized Controlled Trial With Observations on Salivary Oxytocin and Cortisol Changes","Inclusion Criteria:\n\nParticipants will be eligible for this study if they:\n\n1. are experiencing anxiety as evidenced by a BAI-C score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63), and\u002For a C-BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63);\n2. have symptoms that have persistent for more than 3 months;\n3. are able to provide informed consent for participation, and complete treatments and questionnaires as scheduled; and\n4. have no suicidal ideation, as evidenced by \"no\" answers or a score of \\\u003C3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS).\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n1. have unstable systemic medical conditions that may limit their participation in the study, for example, severe liver, cardiovascular, or kidney impairment; gastrointestinal or endocrine dysfunction; malignancy; autoimmune disease; acute infectious disease; or any conditions with unstable vital signs or require intensive hospitalization;\n2. have bipolar or psychotic disorder (e.g. schizophrenia);\n3. have a history of brain injury or surgery;\n4. have alcohol abuse or substance abuse;\n5. are pregnant or in lactation, or intend to conceive;\n6. have heart pacemaker or other metal devices implanted in the body;\n7. have concurrent or use of drug treatment for anxiety\u002Fdepression in the previous 6 months;\n8. have treatment with acupuncture or brain stimulation in the previous 6 months;\n9. have a history of epilepsy;\n10. have a condition of bleeding tendency, or coagulopathy, or currently receiving anti-coagulant treatment; or\n11. involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.","ALL","15 Years","22 Years",{"count":21,"type":22},148,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is an assessor-blinded, randomized, MAS-controlled trial. A total of 148 adolescents aged 15-22 years experiencing mild to moderate anxiety or depressive symptoms will be recruited. They will be randomly assigned to DCEAS+BA (n = 74) and MAS (n = 74) for 2 sessions per week for 8 weeks, followed by a 4-week post-treatment observation period. A post-intervention visit will be held at week 12. The primary outcome will be assessed using the Chinese version of the Beck Anxiety Inventory (BAI-C). The secondary outcomes include the Beck Depression Inventory II (C-BDI-II) for depression, the Zung Self-Rating Anxiety Scale (SAS) and the Zung Self-Rating Depression Scale (SDS) as additional assessments for anxiety and depression, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, and the World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) for the general quality of life. Assessment will be carried out every 4 weeks till week 12, while saliva will be collected at baseline and at the end of the 8 weeks. Salivary oxytocin and cortisol will be analyzed. A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the two groups and linear regression will be conducted to examine intercorrelations among clinical improvement and changes in biomarker levels. Subgroup analysis will be conducted to identify specific effects of DCEAS+BA.",[28,29],"Psychological Distress","Insomnia",[31,29,32,33],"Psychological distress","Acupuncture","Adolescent","RECRUITING","2026-08-18",{"date":37,"type":38},"2026-08-20","ACTUAL",{"date":35,"type":38},{"date":41,"type":22},"2028-09",{"name":43,"class":44},"The University of Hong Kong","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100631981","testing-an-adaptive-intervention-for-peer-supported-mobile-health-for-primary-care-veterans-with-psychological-distress-100631981","NCT07507747","Testing an Adaptive Intervention for Peer-Supported Mobile Health for Primary Care Veterans With Psychological Distress","Peer mHealth","Inclusion Criteria:\n\n* Veteran enrolled in primary care at one of 3 VA facilities (Philadelphia, PA; Ann Arbor, MI; and Bedford, MA)\n* clinically significant psychological distress on at least one DASS-21 subscale (Depression =\\> 10, Anxiety =\\> 8, Stress =\\> 13)\n\nExclusion Criteria:\n\n* symptoms that may preclude active engagement in the intervention such as gross cognitive impairment or current symptoms of mania or psychosis\n* suicide risk as measured by the P4 Suicide Assessment\n* plan to engage in psychotherapy during the intervention period\n* started or changed the dose of a psychotropic medication in the last two months\n* voice a preference to be directly referred to mental health specialty care","18 Years",{"count":55,"type":22},384,[25],"Many Veterans experience psychological distress including depression, PTSD, anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. VA mobile health applications (mHealth apps) that teach skills to manage psychological distress are widely available. However, Veterans rarely use these apps enough to experience health benefits. Peer specialists are VA employees who are trained to use their lived experiences in mental health recovery to help other Veterans. Peers can provide support and accountability to Veterans as they use mHealth apps. Peers working in VA primary care settings are easily accessible to Veterans who receive VA services. This study aims to improve the health of Veterans by testing the effectiveness of peer-supported mHealth in reducing psychological distress. It will also test how much peer support Veterans need to improve their health with using mHealth apps.",[28],[60,61,62,63,64],"peer support","mHealth","Veterans","SMART design","psychological distress","NOT_YET_RECRUITING","2026-08-17",{"date":68,"type":38},"2026-08-19",{"date":70,"type":22},"2026-09-01",{"date":72,"type":22},"2030-04-30",{"name":74,"class":75},"VA Office of Research and Development","FED",5,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":45},"100652024","effectiveness-of-cognitive-behavioral-intervention-for-trauma-in-schools-cbits-a-study-with-pakistani-adolescents-100652024","NCT07768540","Effectiveness of Cognitive Behavioral Intervention for Trauma in Schools (CBITS): A Study With Pakistani Adolescents","Inclusion Criteria:\n\nStudents who are 10-16 years of age, have experienced at least one trauma.\n\nExclusion Criteria:\n\nStudents who have sexual abuse as only traumatic event",true,"10 Years","16 Years",{"count":87,"type":22},50,[25],"This study will evaluate whether a school-based counseling program, Cognitive Behavioral Intervention for Trauma in Schools (CBITS), helps reduce trauma-related symptoms and improve psychological functioning in adolescents in Pakistan who have experienced traumatic events. Students will first be screened to identify those with trauma exposure and related symptoms. Eligible students will receive the CBITS program, delivered at their school by the researcher. Researcher will measure changes in trauma-related symptoms and other psychological outcomes before and after the intervention to determine whether the program is effective for this population.",[91,28,92],"Post Traumatic Stress Symptoms","Trauma Exposure","2026-08-14",{"date":66,"type":38},{"date":96,"type":38},"2025-12-01",{"date":98,"type":22},"2027-02-28",{"name":100,"class":44},"National University of Modern Languages",{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":83,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100651870","virtual-nature-versus-guided-imagery-for-anxiety-and-well-being-in-hospitalized-older-adults-100651870","NCT07765355","Virtual Nature Versus Guided Imagery for Anxiety and Well-Being in Hospitalized Older Adults","Bottom-Up Virtual Nature Versus Top-Down Guided Imagery in Hospitalized Older Adults: A Randomized Parallel-Group Clinical Trial","Inclusion Criteria:\n\n* Aged 65 years or older\n* Receiving inpatient hospital care, with at least two weeks of hospitalisation at the time of enrolment\n* Montreal Cognitive Assessment (Hungarian version) score of 18 or above, with education correction\n* Physically able to safely wear a head-mounted virtual reality display\n* Adequate corrected or uncorrected vision and hearing\n* Able to communicate in Hungarian\n* Stable psychiatric and cardiovascular condition, as determined from medical history and in consultation with the treating physician\n* Able to provide independent written informed consent\n\nExclusion Criteria:\n\n* Epilepsy with recurrent seizures, or photosensitivity\n* Neurological condition associated with increased risk during virtual reality use, including Meniere's disease and significant carotid stenosis\n* Active psychosis, hallucinations, or severe depression with psychotic features\n* Open wound or skin lesion on the face, chronic neck pain, or spinal condition preventing safe use of the head-mounted display\n* Severe uncorrectable sensory impairment\n* Unstable psychotropic medication during the preceding eight weeks\n* Regular use of analgesic or psychotropic medication that may substantially affect perception of the experience\n* Active alcohol or substance use disorder within the past year\n* Refusal or inability to provide informed consent\n\nEnrolment is deferred, rather than excluded, in the presence of active delirium or infectious illness, until the condition resolves.","65 Years",{"count":110,"type":22},60,[25],"Long hospital stays can be difficult for older adults. Being confined to a ward, with limited mobility and little access to the outdoors, may contribute to anxiety, low mood, and reduced well-being. Contact with nature is known to support relaxation and emotional recovery, but hospitalized patients often cannot go outside.\n\nThis study compares two ways of bringing a nature experience to patients who are staying in hospital. In the first approach, participants wear a virtual reality headset and watch 360-degree videos filmed in real natural settings near Budapest: a meadow, a stream, and a mountain. The nature scene reaches them through their eyes and ears. In the second approach, participants listen to a short recorded audio guide and picture the same three nature scenes in their own minds, with their eyes closed. Here the nature scene is created by their own imagination.\n\nBoth approaches use exactly the same nature themes. The only difference is how the experience reaches the person: from the outside through the senses, or from the inside through imagination. The study asks whether these two routes have different effects, and whether they can be told apart by measuring heart rate variability, which reflects how the body's automatic nervous system responds.\n\nParticipants are adults aged 65 or older who have been in hospital for at least two weeks. After joining the study, each participant is first observed for two weeks while receiving only their usual hospital care. This period serves as their own comparison. They are then assigned by chance to one of the two approaches and take part in three sessions over two weeks. Questionnaires and brief cognitive tests are completed at three points: when joining, before the sessions begin, and after the sessions end.\n\nThe main question is whether anxiety symptoms decrease more during the session period than during the preceding period of usual care. The study also looks at mood, attention and memory, well-being, and resilience.",[114,115,116,28,117],"Anxiety","Hospitalization","Quality of Life","Depression",[119,120,121,122,123,124,125,126,127,128,129],"virtual reality","guided imagery","nature exposure","heart rate variability","hospitalized older adults","top-down processing","bottom-up processing","RMSSD","geriatrics","Katathym Imaginative Psychotherapy","symbol therapy","2026-08-10",{"date":93,"type":38},{"date":133,"type":38},"2025-06-01",{"date":135,"type":22},"2027-01",{"name":137,"class":44},"Semmelweis University",2,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":154,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":45},"100644472","bridging-the-gap-in-psychosocial-care-for-cancer-survivors-100644472","NCT07672314","Bridging the Gap in Psychosocial Care for Cancer Survivors","Bridging the Gap in Psychosocial Care for Cancer Survivors: Integrating Digital Screening With Navigation Call","BRIDGE","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Under oncological care at the USB for ≥9 months\n* Completion of primary cancer treatment (see definition below)\n* Attendance at routine oncological follow-up at USB\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Primary brain tumors\n* Severe cognitive impairment\n* Acute psychiatric symptoms that may impair the participant's ability to provide informed consent or comply with study procedures\n* Insufficient German language skills",{"count":87,"type":22},[25],"The study aims to assess the feasibility and acceptability of the implementation of a routine digital psychosocial screening combined with a psycho-oncological Navigation Call for cancer survivors after completion of primary treatment with the goal to improve identification of psychosocial needs and facilitate access to supportive care.",[151,28,152,153],"Cancer Survivorship","Psycho-Oncology","Supportive Care",[155,156,157,158,159,160,161,162,163],"Cancer survivors","Survivorship care","Digital screening","Psycho-oncology","Psychosocial distress","Patient-reported outcomes (PROs)","Navigation Call","Feasibility study","Acceptability","2026-08-07",{"date":130,"type":38},{"date":167,"type":38},"2026-06-26",{"date":169,"type":22},"2028-05",{"name":171,"class":44},"University Hospital, Basel, Switzerland",{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":205,"leadSponsor":207,"locationsCount":45},"100650880","support-and-healing-intervention-for-adolescents-with-a-parent-diagnosed-with-cancer-shine-100650880","NCT07751185","Support and Healing Intervention for Adolescents With a Parent Diagnosed With Cancer (SHINE)","Support and Healing Intervention for Navigating Parental Cancer Experiences (SHINE): A Mixed-Methods Study to Develop and Pilot-Test a Family-Centered Psychosocial Intervention for Adolescents With a Parent Diagnosed With Cancer","SHINE","Inclusion Criteria:\n\nParent or caregiver aged 18 years or older with a documented diagnosis of Stage I-IV (or equivalent) cancer.\n\nParent or caregiver has at least one adolescent child between the ages of 10 and 17 years living in the household.\n\nParent\u002Fcaregiver and adolescent are able to communicate in English or Spanish. Parent or caregiver is willing and able to provide informed consent, and the adolescent is willing and able to provide assent.\n\nFamily is willing and able to participate in study procedures, including intervention sessions and study assessments.\n\nExclusion Criteria:\n\nAdolescent younger than 10 years or older than 17 years. Parent\u002Fcaregiver or adolescent unable to communicate in English or Spanish. Parent\u002Fcaregiver or adolescent with significant cognitive impairment or developmental delay that would prevent meaningful participation in study procedures.\n\nFamily unable or unwilling to complete study procedures or follow-up assessments.\n\nParent\u002Fcaregiver unwilling or unable to provide informed consent, or adolescent unwilling or unable to provide assent.",{"count":181,"type":22},80,[25],"e purpose of this study is to develop and evaluate SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences), a family-centered program designed to support adolescents whose parent has been diagnosed with cancer.\n\nThe study has two phases. In the first phase, parents and adolescents will participate in interviews or focus groups to help researchers understand their experiences and identify the types of support that families need. Information from these discussions will be used to refine the SHINE program.\n\nIn the second phase, families will be randomly assigned to either receive the SHINE program or continue with their usual supportive care. The SHINE program consists of approximately four sessions delivered over 8 weeks and focuses on improving communication, coping skills, resilience, and emotional well-being. Adolescents will complete questionnaires before the program begins, immediately after the 8-week intervention period, and 3 months later.\n\nResearchers will evaluate whether SHINE is feasible to deliver, acceptable to families, and shows promise for improving psychosocial outcomes among adolescents coping with a parent's cancer diagnosis.",[185,28,186],"Cancer","Adaptation, Psychological",[188,189,190,191,192,193,194,195,196,197,198,199,200,201,178],"Parental cancer","Adolescents","Family-centered intervention","Psychosocial intervention","Supportive care","Cancer survivorship","Family communication","Coping","Resilience","Peer support","Pediatric psychosocial oncology","Behavioral intervention","Mixed-methods","Randomized controlled trial","2026-07-31",{"date":164,"type":38},{"date":70,"type":22},{"date":206,"type":22},"2029-12-31",{"name":208,"class":44},"University of Texas Southwestern Medical Center",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":45},"100648858","digital-psychoeducational-intervention-for-young-adults-with-fertility-related-distress-following-cancer-diagnosis-100648858","NCT07729696","Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis","Effectiveness of a Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed with cancer.\n* Self-report fertility-related distress.\n* Aged 18 to 40 years old.\n* Able to speak Bahasa (the national language of Indonesia).\n* Have a performance status ECOG score of 0-2.\n\nExclusion Criteria:\n\n* Have a severe medical condition which impacts their level of consciousness.\n* Diagnosed with a major psychiatric comorbidity.\n* Unable to fill out the study questionnaires.\n* Unable to decide to participate due to cognitive impairment, decreasing consciousness level, or difficulty verbalizing their wishes.","40 Years",{"count":218,"type":22},38,[25],"The goal of this randomized controlled trial is to evaluate the effectiveness of a digital psychoeducational intervention for young adults experiencing fertility-related distress following a cancer diagnosis. It will also assess how the intervention supports the development of effective coping strategies and social support networks. The main questions it aims to answer are: Does the digital psychoeducational intervention reduce anxiety and depression severity compared with usual care? Does the digital psychoeducational intervention increase patients' self-efficacy, social support, and coping compared with usual care? Does the digital psychoeducational intervention increase patients' quality of life compared with usual care? Researchers will compare the digital psychoeducational intervention to usual care (standard treatment) to see if the intervention effectively manages psychological problems and improves quality of life. Participants will:Be randomly assigned to either the experimental group or the control group. Attend an initial face-to-face introductory session, followed by four digital psychoeducational modules delivered via a mobile phone application (if assigned to the experimental group). Engage with module content including an e-booklet, video, and quizzes, with a new module opening every two days. Receive standard treatment from healthcare providers, and later receive the psychoeducational materials at the end of the data collection period (if assigned to the control group). Complete a series of validated questionnaires measuring depression, anxiety, coping, self-efficacy, social support, and quality of life at four different time points throughout the study.",[222,185,223,224,225,28,114],"Neoplasm","Psychoeducational Intervention","Young Adults","Fertility Outcomes","2026-07-23",{"date":228,"type":38},"2026-07-27",{"date":230,"type":22},"2026-08-24",{"date":232,"type":22},"2026-12-14",{"name":234,"class":44},"Gadjah Mada University",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":45},"100648488","feasibility-of-a-real-world-financial-psycho-oncology-intervention-to-address-cancer-related-financial-distress-100648488","NCT07724041","Feasibility of a Real-world, Financial Psycho-oncology Intervention to Address Cancer-related Financial Distress","Inclusion Criteria:\n\n* Adult patients with cancer receiving treatment at the UAB Medical Oncology and\u002For UAB Supportive Care clinics\n\nExclusion Criteria:\n\n* non-English speakers\n* patients with non-melanoma skin cancers\n* patients with dementia\u002Fcognitive impairments",{"count":242,"type":22},20,[25],"The goal of this pilot, feasibility study is to evaluate the feasibility and preliminary impact of a finance-specific psycho-oncology intervention, as well as to explore perceptions of and experiences with this financial psycho-oncology intervention for patients with cancer experiencing financial hardship. The main questions it aims to answer are:\n\n1. Is this financial psycho-oncology intervention feasible, acceptable, and appropriate for patients with cancer experiencing financial hardship?\n2. How can we refine the financial psycho-oncology intervention to best address financial distress for patients with cancer experiencing financial hardship?\n\nPatients enrolled in the intervention will receive 2, 60-minute long, finance-specific psycho-oncology sessions per month over the course of 3 months, for a total of 6 sessions over the course of the intervention. Patients will complete surveys during intervention enrollment and after intervention completion to assess secondary outcomes of financial hardship, psychological distress, stress, and anxiety. Individuals who consent to the financial psycho-oncology intervention will also be invited to participate in a 30-minute semi-structured interview to explore their perceptions of and experiences with the financial psycho-oncology intervention, including concepts of participation and engagement, relevance and acceptability, content and understanding, logistics and practicality, and potential impact.",[185,246,28],"Financial Hardship","2026-07-20",{"date":226,"type":38},{"date":250,"type":22},"2026-09",{"date":252,"type":22},"2027-08",{"name":254,"class":44},"University of Alabama at Birmingham",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":45},"100648446","feasibility-of-a-culturally-adapted-nurse-led-cope-intervention-for-caregivers-of-children-with-autism-spectrum-disorder-100648446","NCT07722949","Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder","Feasibility of Culturally Adapted, Nurse-Led COPE Intervention on Psychological Wellbeing of Primary Caregivers of Child With Autism Spectrum Disorder (CASD)","COPE-ASD","Inclusion Criteria:\n\n* Male or female primary caregivers aged 18 years or older.\n* Primary caregiver of a child with a confirmed diagnosis of Autism Spectrum Disorder (ASD).\n* Able to communicate in Urdu.\n* Willing and able to provide written informed consent.\n* Available to attend all intervention sessions and follow-up assessments.\n\nExclusion Criteria:\n\n* Caregivers currently participating in another structured psychosocial, behavioral, or parenting intervention.\n* Caregivers with a diagnosed severe psychiatric illness or cognitive impairment that would interfere with participation.\n* Caregivers unable to communicate effectively in Urdu.\n* Caregivers who decline or are unable to provide informed consent.\n* Caregivers who are unavailable to complete the intervention or follow-up assessments.",{"count":264,"type":22},77,[25],"This study aims to evaluate the feasibility of a culturally adapted, nurse-led Creating Opportunities for Parent Empowerment (COPE) intervention to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) in Pakistan. The study will use an exploratory sequential mixed-methods design comprising a qualitative needs assessment followed by a pilot randomized controlled feasibility trial. Qualitative interviews will identify caregivers' training needs and inform the cultural adaptation of the COPE intervention. Eligible caregivers will then be randomly assigned to either an intervention group receiving the culturally adapted COPE program in addition to routine care or a control group receiving routine care alone. The intervention consists of four weekly nurse-led sessions focusing on psychoeducation, cognitive restructuring, coping strategies, positive parenting, emotional regulation, and family resilience. Psychological wellbeing will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21) at baseline and one month after the intervention. The study will also evaluate recruitment, retention, intervention adherence, acceptability, and implementation feasibility to inform the design of a future definitive randomized controlled trial.",[268,28,117,114],"Autism Spectrum Disorder",[268,270,271,272,201],"Caregivers","Psychological Wellbeing","Feasibility Trial",{"date":226,"type":38},{"date":275,"type":38},"2026-07-15",{"date":277,"type":22},"2027-05-25",{"name":279,"class":44},"Khyber Medical University Peshawar",{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":17,"minAge":288,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":296,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100647686","interactive-nature-based-virtual-reality-to-reduce-anxiety-low-mood-and-feelings-of-helplessness-in-hospitalized-older-adults-with-chronic-illness-zenctuary-vr-100647686","NCT07712549","Interactive Nature-Based Virtual Reality to Reduce Anxiety, Low Mood, and Feelings of Helplessness in Hospitalized Older Adults With Chronic Illness (Zenctuary VR+)","Multicenter Randomized Controlled Trial Investigating the Psychological Effects of a Nature-Based VR Intervention in Multimorbid Elderly Patients - ZenctuaryVR+, Within the Framework of the HU-RIZONT International Excellence Research Collaboration Program","ZenctuaryVR+","Inclusion Criteria:\n\n* Aged 60 years or older\n* Diagnosed with at least one chronic medical condition\n* Currently receiving inpatient hospital care\n* Expected to remain hospitalized for at least four weeks following enrolment\n* Physically able to use a head-mounted virtual reality device, as determined by the treating clinical team\n* Able to provide written informed consent\n* Able to complete study assessments and participate in the intervention procedures\n\nExclusion Criteria:\n\n* Cognitive impairment, defined as a score below 18 on the Montreal Cognitive Assessment (MoCA)\n* Impaired consciousness or reduced alertness that would prevent meaningful participation\n* Current or previous diagnosis of a psychotic disorder\n* Current substance use disorder that would interfere with participation in the study procedures\n* Current treatment with antipsychotic medication\n* Untreated epilepsy\n* Severe vestibular dysfunction or recurrent vertigo\n* Any medical condition judged by the treating physician to make participation unsafe or inappropriate","60 Years",{"count":290,"type":22},100,[25],"Prolonged hospitalization can reduce opportunities for independent activity, choice, and control and may contribute to passivity, low mood, anxiety, and distress in some older adults. Zenctuary VR+ is a seated, nature-based virtual reality program that combines calming environments with simple, low-demand activities. The active program allows participants to make choices, move between predefined locations, and influence elements of the virtual environment. Trained staff supervise every session and provide support when needed.\n\nThe trial evaluates whether the interactive version of Zenctuary VR+ reduces psychological distress more than passive exposure to the same virtual environments. A total of 100 hospitalized adults aged 60 years or older will be randomly assigned to the interactive VR condition or the passive VR condition. Eligible participants are expected to remain hospitalized for at least four weeks following enrolment. Both groups will receive six sessions over three weeks. Psychological distress and related psychological factors will be assessed before the first session, immediately after the three-week intervention period, and four weeks after the final session.",[28,294,295],"Chronic Disease","Learned Helplessness",[297,201,298,299,300,301,302,31],"Virtual reality","Digital health intervention","Nature exposure","Self-efficacy","Older adults","Learned helplessness","2026-07-17",{"date":305,"type":38},"2026-07-21",{"date":307,"type":22},"2026-11-01",{"date":309,"type":22},"2028-03-31",{"name":311,"class":44},"Moholy-Nagy University of Art and Design",3,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":320,"minAge":53,"maxAge":216,"enrollmentInfo":321,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":323,"conditions":324,"keywords":327,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":333,"leadSponsor":334,"locationsCount":4},"100647170","effect-of-mandala-art-therapy-on-childbirth-fear-and-anxiety-in-expectant-fathers-100647170","NCT07704541","Effect of Mandala Art Therapy on Childbirth Fear and Anxiety in Expectant Fathers","The Effect of Mandala Art Therapy on Fear and Anxiety of Childbirth in Expectant Fathers Waiting Outside the Delivery Room: A Randomized Controlled Study","Inclusion Criteria:\n\n* Fathers whose partners are nulliparous pregnant women Fathers aged 18 years and older Fathers whose partners are admitted for planned vaginal delivery Fathers present in the obstetric waiting area during the study period Fathers who are able to read and understand Turkish Fathers who voluntarily agree to participate in the study\n\nExclusion Criteria:\n\n* Presence of obstetric emergency or unplanned change in delivery method (e.g., emergency cesarean section) History of diagnosed psychiatric disorders requiring treatment (e.g., anxiety disorders) Inability to understand or complete study questionnaires Absence from the waiting area during the intervention period","MALE",{"count":21,"type":22},[25],"This randomized controlled trial is designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor. Eligible participants will be randomly allocated to either the intervention or the control group. Fathers assigned to the intervention group will participate in a single 20-25-minute mandala art therapy session, whereas those in the control group will receive standard care without any additional intervention. Childbirth fear and state anxiety will be assessed using the Fathers' Birth Fear Scale and the State subscale of the Spielberger State-Trait Anxiety Inventory, respectively, at baseline and immediately following the intervention. The findings of this study are expected to provide evidence regarding the effectiveness of mandala art therapy as a non-pharmacological intervention for alleviating childbirth-related fear and anxiety among expectant fathers.",[325,326,28],"Paternal Childbirth Fear","State Anxiety",[328,329,330],"mandala art therapy","childbirth fear","obstetric waiting room",{"date":247,"type":38},{"date":70,"type":22},{"date":307,"type":22},{"name":335,"class":44},"Inonu University",{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":353,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":45},"100642919","steps---stress-training-and-engagement-via-phone-based-systems-100642919","NCT07639697","STEPS - Stress Training and Engagement Via Phone-Based Systems","Mindfulness Training and Respiration Biosignal Feedback - Study 3","Inclusion Criteria:\n\n* Ages 18-30 years of Age\n* Fluent in English\n* Psychological distress\n* Interested in completing smartphone guided training sessions remotely for 14 days\n* Willing and able to wear physiological monitoring equipment\n* Willing to be randomized to one of three conditions\n* Located in the United States\n* Access to a smartphone without snapdragon processors to complete guided training sessions\n\nExclusion Criteria:\n\n* Currently pregnant\n* Current or previous diagnosis with psychosis or schizophrenia","30 Years",{"count":345,"type":22},300,[25],"This study will evaluate engagement, usability, and psychological outcomes associated with participation in smartphone-based stress management or mindfulness training program among young adults. The study will compare multiple versions of a digital training program delivered through the Equa mobile application.\n\nParticipants will be individually randomized to one of several app-based training programs using a stratified randomization procedure. Each program consists of guided daily lessons completed over a 14-day period and is designed to support stress management and well-being through structured skill development activities.\n\nPrimary objectives include evaluating user satisfaction and usability of the digital platform and assessing changes in mindfulness-related skills and mental distress over time.\n\nParticipants will:\n\nComplete surveys assessing demographics and psychological well-being at baseline, post-intervention, and one-month follow-up.\n\nComplete a 14-day smartphone-delivered training program consisting of guided lessons while physiological data are collected using wearable sensors.\n\nSome participants may receive additional in-app features designed to support personalized learning or engagement with training lessons.\n\nSome participants will complete brief questionnaires before and after selected lessons to assess short-term changes associated with lesson participation.",[28,349,350,351,352],"Mindfulness Skills","Usability Satisfaction","Program Engagement","Loneliness",[354,355,356,357,64,358],"young adults","mental health","well-being","mindfulness skills","stress management",{"date":247,"type":38},{"date":361,"type":38},"2026-06-17",{"date":363,"type":22},"2027-07",{"name":365,"class":366},"Equa Health","INDUSTRY",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":343,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":374,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":383,"locationsCount":45},"100603471","mindfulness-training-and-respiration-biosignal-feedback---study-2-100603471","NCT07136948","Mindfulness Training and Respiration Biosignal Feedback - Study 2","Inclusion Criteria:\n\n* Ages 18-30 years of Age\n* Fluent in English\n* Psychological distress\n* Willing to participate in guided meditation or stress management training.\n* Willing and able to wear earbud headphones and a shirt which uses sensors to track motion and physiological measures.\n* Willing to be randomized to one of two conditions\n* Willing to provide ratings on their training experience\n\nExclusion Criteria:\n\n* Currently pregnant\n* Current or previous diagnosis with psychosis or schizophrenia",{"count":110,"type":22},[25],"The goal of this research is to test usability and user satisfaction with a new breathing feature on the meditation app, Equa, to help young adults who are distressed, understand their physiological responses and mindfulness skill development during meditation.\n\nOur main aims are to test an algorithm that can use physiologic signals to give feedback about how participant physiology is changing during guided lessons on the meditation app, Equa through:\n\n* Assessing user satisfaction and usability\n* Measuring how much participant mindfulness skills are improving\n\nParticipants will:\n\n* Complete a survey about demographics, their thoughts and feelings before and after the mindfulness meditation program\n* Complete 14 smartphone guided mindfulness meditation training units while physiological measures are being recorded\n* A subset of participants will see a graph tracking their physiological responses from the guided meditation lesson and predictive mindfulness skill scores\n* Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills",[28,349,350],[378,354,355,356,357,64],"respiration biosignal feedback",{"date":247,"type":38},{"date":381,"type":38},"2025-07-21",{"date":250,"type":22},{"name":365,"class":366},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":391,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":45},"100648084","ecological-momentary-intervention-e-breathing-to-reduce-psychological-distress-in-adolescents-100648084","NCT07717112","Ecological Momentary Intervention (E-Breathing) to Reduce Psychological Distress in Adolescents","Effect of Slow-Paced Breathing Via Ecological Momentary Intervention on Reducing Psychological Distress in Adolescents: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged between 11 to17 years;\n2. With at least one mild mental health state as reported by Depression, Anxiety, and Stress Scale-21;\n3. Able to read and understand Chinese;\n4. Have access to a mobile phone and data plan.\n\nExclusion Criteria:\n\n1. With a diagnosis of hearing, visual, or physical impairments that may hinder study participation;\n2. With a diagnosed history of major mental illnesses or other diagnosed medical conditions that may affect study participation.","11 Years","17 Years",{"count":290,"type":22},[25],"A two-arm randomized controlled trial (RCT) will be conducted to test a mobile-based intervention, E-breathing, for early detection and intervention to address psychological distress in at-risk adolescents in Hong Kong. E-breathing harnesses the science of real-time, in-situ assessment approach - Ecological Momentary Assessment (EMA) - to capture the psychological symptoms and needs of adolescents. Based on the real-time data collected via smartphone, the mobile application prompts the practice of slow-paced breathing as an Ecological Momentary Intervention (EMI) to reduce psychological distress. This RCT will recruit a total of 100 participants who will be randomly allocated to either (1) an intervention group (EMI group), where they will receive a feedback prompt when they score high on negative affect (i.e., E-breathing) or (2) the control group (EMA group), where they will only complete EMAs without feedback. This project aims to investigate the feasibility and effectiveness of E-breathing in improving psychological symptoms in Hong Kong adolescents. This project also examine the underlying physio-mechanisms of the effects of E-breathing on psychological outcomes in this target population.",[28,397,114,398],"Depressed Mood","Stress","2026-07-16",{"date":305,"type":38},{"date":402,"type":22},"2026-10-01",{"date":404,"type":22},"2027-05-31",{"name":406,"class":44},"The Hong Kong Polytechnic University",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":424,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":434,"leadSponsor":436,"locationsCount":45},"100647358","evaluation-of-a-remote-behavioural-stress-recovery-intervention-for-myocardial-infarction-patients-younger-than-fifty-five-brim-55-a-feasibility-study-100647358","NCT07706816","Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study","BRIM-55","Inclusion criteria:\n\n* Myocardial infarction (MI) before age 55 years\n* MI within one year prior to randomization\n* Report of subjective cardiac distress in the initial interview\n\nExclusion criteria:\n\n* Serious conditions hindering participation (e.g., active substance misuse, severe mental illness)\n* Insufficient Swedish proficiency for study procedures,\n* Disability pension or early retirement at the time of MI","55 Years",{"count":416,"type":22},30,[25],"The goal of this feasibility study is to learn if the randomised controlled trial evaluating the Remote-delivery Balance in Everyday Life (rBEL) programme for adults younger than 55 years who have experienced a myocardial infarction (MI), is feasible.\n\nThe objective is to examine the feasibility of the rBEL programme and the associated study procedures before a controlled evaluation of the programme. This is an uncontrolled, single-arm, pre-post treatment designed study.\n\nParticipants of the target population will take part of the six session over 13 week programme. Feasibility will be evaluated against predefined feasibility criteria regarding study procedures and programme acceptability.",[420,421,422,423,28,114],"Cardiac Disease","Depression and Quality of Life","Cardiac Distress","Myocardial Infarction",[425,426,427,428,429,430,431],"Cardiac distress","Heart Attack","Cognitive Behavioral Therapy","Secondary Prevention","Cardiac Rehabilitation","Stress Recovery","Behavioral Intervention",{"date":399,"type":38},{"date":230,"type":22},{"date":435,"type":22},"2027-06-30",{"name":437,"class":44},"Uppsala University",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":447,"phases":4,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":45},"100618721","care-bia-pilot-study-to-improve-patient-comfort-and-reduce-psychological-distress-during-ia-removal-100618721","NCT07335302","CARE-BI:a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During IA Removal","CARE-BI (Comfort and Analgesia for Removal of Brachytherapy Implants): a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During Intracavitary Applicator Removal","Inclusion Criteria:\n\n* Capable of signing informed consent\n* Age ≥ 18 years old\n* Receipt of multiple intracavitary brachytherapy treatments for gynecologic cancer\n* Capable of completing PRO and patient satisfaction surveys and willing to comply with completion of surveys multiple times throughout and after treatment\n\nExclusion Criteria:\n\n* Patients without ability to sign informed consent\n* Patients unwilling or unable to complete PRO and patient satisfaction surveys at the times required by the study",{"count":446,"type":22},36,"OBSERVATIONAL","The goal of this research study is to learn about the rate of posttraumatic stress disorder (PTSD) experienced by women after undergoing gynecologic brachytherapy.",[28],{"date":399,"type":38},{"date":452,"type":38},"2025-12-18",{"date":454,"type":22},"2028-10-20",{"name":456,"class":44},"M.D. Anderson Cancer Center",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":23,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":45},"100591335","implementation-of-whos-doing-what-matters-in-times-of-stress-in-dutch-small-and-medium-sized-enterprises-smes-100591335","NCT06979089","Implementation of WHO's Doing What Matters in Times of Stress in Dutch Small and Medium-sized Enterprises (SMEs)","Improving the Mental Health of Working Adults in Dutch Small and Medium-Sized Enterprises (SMEs): A Cluster RCT of WHO's Doing What Matters in Times of Stress (DWM)","Inclusion Criteria (SMEs):\n\n* Having 10 to 250 employees\n* Being located in the Netherlands\n\nIn case of insufficient recruitment among SMEs, a mitigation strategy is to recruit public and non-profit organizations, and units of larger organizations, all employing between 10 and 250 employees.\n\nInclusion Criteria (Individual participants):\n\n* 18 years or older\n* Having elevated levels of psychological distress (Kessler Psychological Distress Scale; K10 scores \\> 15.9)\n* Sufficient literacy and mastery (written and spoken) of one of the languages the DWM intervention is being delivered in (i.e., Dutch or English)\n* Having access to an electronic device with internet access to follow the intervention\n* Written informed consent before entering the study\n\nExclusion Criteria (Individual participants):\n\n* Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up\n* Currently receiving specialized psychological treatment (e.g., EMDR or CBT) at the time of screening\n* In case of current psychotropic medication use: being on an unstable dose for at least 2 months or a change in dosage over the past 2 months.\n* Having participated in the preceding ASCEND trial as supervisor (see NCT ID: NCT06989398)",{"count":465,"type":22},518,[25],"The goal of this cluster randomized controlled trial is to explore if mental health in Dutch small and medium-sized enterprises (SMEs) can be improved by the World Health Organization's online program Doing What Matters in Times of Stress (DWM). The main questions it aims to answer are:\n\n* Does DWM improve the mental health of employees working in Dutch SMEs?\n* Does DWM improve work-related outcomes in employees working in Dutch SMEs?\n* How can DWM be implemented at a large scale in Dutch SMEs?\n\nResearchers will compare two groups to see if the DWM program is effective. One group will receive the DWM program and Care-as-Usual (group 1), and the other group will receive Care-as-Usual only (group 2).\n\nParticipants will:\n\n* Follow the online DWM program for 5 weeks (only group 1).\n* Take part in 6 telephone appointments with a facilitator (helper) that provides extra support to complete the program (only group 1).\n* Complete 3 sets of questionnaires. Each set of questionnaire takes about 15 minutes to be completed (group 1 and group 2).",[114,117,28],[117,114,28,470,471,472,473,474,475,476],"Mental health","Work-place mental health","Employee well-being","Digital intervention","Online intervention","Doing What Matters in Times of Stress","Small and medium-sized enterprises","2026-07-14",{"date":399,"type":38},{"date":480,"type":38},"2025-05-19",{"date":482,"type":22},"2027-03",{"name":484,"class":44},"VU University of Amsterdam",{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":494,"briefSummary":496,"conditions":497,"keywords":498,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":510},"100597851","phase-3-psilocybin-microdose-for-psychological-and-existential-distress-in-palliative-care-psyched-pal-rct-100597851","NCT07063862","Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)","PSilocybin Microdose for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site Phase 3 Double-blind, Placebo-controlled, Parallel-arm Clinical Trial","Inclusion Criteria:\n\n1. Patients \\>\u002F=18 years of age with advanced illness under palliative care management, defined as having an estimated 2 to 12 months life expectancy (in the judgment of the palliative care provider)\n2. Experiencing psychological distress, defined as a score of 7 or greater on the Depression, Anxiety, or Well-being item of the Edmonton Symptom Assessment System-revised (ESAS-r)\n3. Living situation falls under one of two categories:\n\n   1. Living in the community (i.e., receiving palliative care as an outpatient or through community home visits)\n   2. Living in a chronic care inpatient facility (i.e., receiving long-term supportive care because care is unable to be provided in a community home - e.g., ALS) and have a family member who can administer the psilocybin\u002Fplacebo medication to the patient\n4. Ability to understand and communicate in English or French\n5. For patients in community settings, patients must be able to have another individual present with them during and for 2 hours after they take their psilocybin\u002Fplacebo dose for the first week of the intervention period\n\nExclusion Criteria:\n\n1. Current or previously diagnosed, or first-degree relative with, psychotic or bipolar disorder\n2. Previously deemed eligible for MAiD with intention to proceed with MAiD regardless of study intervention effectiveness (this criteria is meant to exclude patients who would be unlikely to complete follow-up - those considering or being assessed for MAiD will still be eligible)\n3. Documented or suspected delirium in the past 3 months without a clearly defined reversible cause (e.g. opioid toxicity, infection) and resolution\n4. Documented moderate or severe dementia diagnosis\n5. Inability to provide first-person informed consent\n6. Inability to complete assessments via telephone or video-conferencing platform\n7. Severe or unstable physical symptoms based on the judgment of the palliative care provider\n8. Palliative Performance Scale (PPS) \\\u003C50%\\*\n9. Cancer with known central nervous system (CNS) involvement or other CNS disease\n10. Use of high-dose psychedelic substances in the past year\n11. Taking lithium at any dose\n12. Taking tramadol at any dose\n13. Taking tapentadol at any dose\n14. Taking any monoamine oxidase inhibitor at any dose \\[American Hospital Formulary Service (AFHS) group 28:16.04.12 or 28:36.32, including, but not limited to, moclobemide, tranylcypromine, phenelzine, selegiline, rasagiline\\]\n15. Taking any atypical antipsychotic (aripiprazole, asenapine, brexpiprazole, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)\n\n    a. Note: patients can be included if their atypical antipsychotic is stopped or, if appropriate, substituted with haloperidol 48 hours prior to the start and for the duration of the intervention period and follow-up.\n16. No enteral route of drug administration available\n17. Pregnancy or lactation\n\n    * Does not apply to the open-label access or open-label extension phases (since participants are expected to decline in overall health and function from baseline due to natural disease progression towards the end of life).\n\nIndividuals with dementia (assessed at baseline by the treating team - no formal screening of dementia will be done during the intervention or follow-up period) or delirium are excluded. While the safety and effects of psilocybin have not previously been studied in these populations, it can be reasonably assumed that hallucinogenic substances could exacerbate or lead to worsening of delirium or dementia symptoms common among people at the end of life (e.g., confusion, agitation).\n\nThe use of selective serotonin reuptake inhibitors (SSRIs) and antipsychotic medications (other than atypical antipsychotics) is a relative contraindication. For participants taking either an SSRI or an antipsychotic medication, there are several conditions for participation: (1) the palliative care provider must approve their participation in the study; (2) the SSRI\u002Fantipsychotic medication dose cannot change for the duration of the intervention trial and follow-up, and; (3) the patient must not be taking more than the maximum allowable trial dose for each SSRI.\n\nThe decision to not include SSRI and antipsychotic medications as an absolute contraindication was three-fold. Firstly, there is no empirical evidence from psilocybin microdosing literature that supports these medications as absolute contraindications. Risks related to serotonin syndrome are theoretical in nature for microdosing protocols, with no actual cases being observed. Secondly, the physician investigator team has estimated the risk to participants of rebound syndrome and associated symptoms from being taken off SSRIs and\u002For antipsychotics to be similar to or greater than that of serotonin syndrome. Lastly, to safely have participants stop taking SSRIs and\u002For antipsychotic medications, this would require a relatively long period of time (weeks to months) to taper the medication, which is not feasible for palliative care and end-of-life populations.\n\nAll trial participants must agree to not take any other psychedelic substance for the duration of the clinical trial and follow-up, and to notify the investigative team of any medication changes during intervention or follow-up. Participants must also notify the investigative team if any cannabis products are consumed during the treatment days. Participants must also agree not to take their benzodiazepine or antipsychotic medication, if applicable, within 12 hours (6 hours pre and 6 hours post) of taking their study dose. Participants must also agree not to drive or operate any heavy machinery on any treatment day after taking the drug (psilocybin or placebo) for the duration of the 2-week intervention. Lastly, for patients in the community setting, participants must agree not to take the study dose alone for the first week of the intervention; at least one individual must stay with the participant at the time they take their dose and for at least 2 hours following dose administration. This is to ensure participants are not alone in the event of a serious adverse drug reaction.",{"count":493,"type":22},120,[495],"PHASE3","About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress. Treatment options such as medication and therapy are available; however, they do not always work and can be time-consuming and expensive. We need treatments that work well, quickly, and can be available to all patients with advanced illness who have psychological distress.\n\nPsilocybin, a psychedelic medication (commonly called 'magic mushrooms') works well for improving psychological distress in people with cancer or chronic illness when given in high doses with specific forms of therapy. However, psilocybin has not been well-studied among people with advanced illness, and there are concerns about safety and side effects in people approaching the end of life.\n\nHowever, reports on psilocybin microdosing, which involves taking small doses that do not cause hallucinations and do not require therapy, suggest that this may be effective, safer, and more acceptable for people with advanced illness. We recently completed a small study of psilocybin microdosing. Our results showed psilocybin microdose improved psychological distress in most participants with advanced illness, without serious side effects. Our next step is to do a randomized clinical trial where some patients receive psilocybin microdose and some receive placebo (a drug that contains no medicinal ingredients). By comparing these two groups, we can remove the possibility that improvements in symptoms are only because patients thought they were getting treatment.\n\nWe will enroll 120 patients from inpatient, outpatient, and community care settings across seven sites. Participants in the microdose psilocybin group will receive 2 or 3 mg of psilocybin daily, 4 days per week, for two consecutive weeks. The placebo group will receive placebo with the same treatment schedule. All participants will be offered microdose psilocybin after 2-week follow-up. If this study is successful, we have the potential to change how psychological distress is managed in patients with advanced illness.",[28],[31,499,500],"psilocybin","microdosing","2026-07-08",{"date":503,"type":38},"2026-07-10",{"date":505,"type":38},"2026-01-28",{"date":507,"type":22},"2027-09",{"name":509,"class":44},"Bruyère Health Research Institute.",7,{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":531,"leadSponsor":533,"locationsCount":4},"100541584","development-of-a-multilevel-hiv-prevention-intervention-for-the-emergency-department-100541584","NCT06331767","Development of a Multilevel HIV Prevention Intervention for the Emergency Department","mSYNC: an mHealth SYNdemic-based Consultation-liaison HIV Prevention Intervention for the Emergency Department","mSYNC","Inclusion Criteria:\n\n* At least 18 years old\n* No HIV positive test in electronic medical record or self-reported\n* Past month HIV risk behavior (condomless sex or needle sharing not protected by adherent PrEP \\[pre-exposure prophylaxis\\])\n* Past month use of illicit drugs (excluding marijuana)\n* Belong to at least one of key HIV risk group (transgender woman, MSM, Black\u002FLatinx\u002FIndigenous)\n* Own a smartphone\n* Able to read and understand English\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Medical or psychiatric condition that would interfere with ability to participate in study procedures\n* Presented to the emergency department (ED) for a psychiatric issue\n* Expected to be admitted to ED for more than 48 hours",{"count":290,"type":22},[25],"The goal of this clinical trial is to pilot test a psychosocial-behavioral mobile health (mHealth) human immunodeficiency virus (HIV) prevention intervention in people who use drugs presenting to the emergency department (ED). The main question the study aims to answer is: is the intervention acceptable and appropriate? Participants will use the mHealth app while waiting in the ED and also at home for 90 days. Participants will be asked to complete surveys at baseline, before leaving the ED, and at 30-, 60-, and 90-day follow up visits.",[523,524,525,28,526,527],"HIV","Drug Use","Mental Health","Social Marginalization","Problems With Access to Health Care",{"date":529,"type":38},"2026-07-09",{"date":250,"type":22},{"date":532,"type":22},"2029-04",{"name":534,"class":44},"Brigham and Women's Hospital",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":83,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":447,"phases":4,"briefSummary":545,"conditions":546,"keywords":550,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":556,"leadSponsor":558,"locationsCount":4},"100646141","psychological-support-and-psycho-emotional-trajectories-in-cancer-genetics-100646141","NCT07695506","Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics.","Apport d'un Accompagnement Psychologique au Cours du Parcours en oncogénétique : étude de la Trajectoire Psycho-émotionnelle Des Consultants","PsyOncoGen","Inclusion Criteria:\n\n* Adult individuals referred for their first genetic counselling consultation, with an indication for a genetic test;\n* Individuals capable of understanding and expressing themselves sufficiently in French (able to complete questionnaires and participate in interviews);\n* Must not present with neurocognitive or psychopathological disorders, or impairments that could compromise their understanding of the study and informed decision-making regarding participation;\n* Affected or unaffected index case or relatives.\n\nExclusion Criteria:\n\n* Individuals under guardianship, curatorship, or a legal protection order, or deprived of liberty by a judicial or administrative decision;\n* Individuals presenting with neurocognitive or psychopathological disorders and\u002For linguistic difficulties that preclude understanding the study and questionnaires, or participating in an informed manner;\n* Individuals already enrolled in a hereditary cancer testing care pathway.",{"count":544,"type":22},220,"Undergoing a cancer genetic testing pathway and receiving results regarding a personal or familial cancer predisposition can generate substantial, multifaceted psycho-emotional distress for patients. While professional psychological support is strongly recommended in clinical guidelines, very few studies have formally quantified its actual contribution to the longitudinal psycho-emotional experiences of patients within real-world clinical practices. The primary objective of the PsyOncoGen study is to describe the longitudinal psycho-emotional trajectories of patients within the routine care pathway. It evaluates the clinical impact of psychological support by observing the natural outcomes of patients who choose to accept this systematically offered service versus those who choose to decline it. The study will follow 220 adult patients across two natural cohorts determined solely by patient choice: 110 patients utilising the clinical psychological support and 110 patients declining it.",[28,547,548,549],"Genetic Testing","Hereditary Neoplastic Syndromes","Neoplasms",[551,547,28,552,158],"Hereditary Cancer Syndromes","Psychological Needs","2026-07-06",{"date":503,"type":38},{"date":70,"type":22},{"date":557,"type":22},"2028-06-01",{"name":559,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":83,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":575,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":587,"locationsCount":45},"100644982","efficacy-of-vicarious-post-traumatic-growth-intervention-for-nurses-in-emergency-units-100644982","NCT07677527","Efficacy of Vicarious Post-Traumatic Growth Intervention for Nurses in Emergency Units","Efficacy of Vicarious Post-Traumatic Growth Intervention for Nurses in Emergency Units: A Randomized Controlled Trial","VPTG-RCT","Inclusion Criteria:\n\n1. Registered nurses currently employed in emergency departments.\n2. Minimum six months of emergency department work experience.\n3. Able to read and understand English or Urdu.\n4. Willing to provide informed consent.\n5. Available to participate throughout intervention and follow-up assessments.\n\nExclusion Criteria:\n\n1. Current diagnosis of severe psychiatric disorder requiring intensive treatment.\n2. Current participation in trauma-focused psychotherapy.\n3. Cognitive impairment affecting study participation.\n4. Planned transfer from emergency unit during study period.\n5. Refusal to provide informed consent.",{"count":110,"type":22},[25],"This randomized controlled trial aims to evaluate the efficacy of a Vicarious Post-Traumatic Growth (VPTG) Intervention among nurses working in emergency units. Emergency nurses are frequently exposed to traumatic events through patient care, which may contribute to vicarious trauma and psychological distress. The intervention is designed to facilitate positive psychological growth, resilience, adaptive coping, and psychological well-being while reducing the adverse impact of indirect trauma exposure. Participants will be randomly assigned to intervention and control groups. Outcomes will be assessed at baseline, post-intervention, and follow-up periods to determine the effectiveness of the intervention in promoting vicarious post-traumatic growth and reducing vicarious trauma among emergency nurses.",[572,28,573,574],"Vicarious Trauma","Post-Traumatic Growth, Psychological","Psychological Well-being",[576,577,578,196,572,525,579,580],"Vicarious Post-Traumatic Growth","Emergency Nurses","Randomized Controlled Trial","Psychological Intervention","Coping Strategies","2026-07-02",{"date":583,"type":38},"2026-07-07",{"date":585,"type":38},"2026-03-01",{"date":70,"type":22},{"name":588,"class":44},"Fatima Jinnah Women University",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":596,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":45},"100546025","change-my-story-task-shifted-mental-health-intervention-100546025","NCT06389565","Change My Story Task Shifted Mental Health Intervention","Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression","Inclusion Criteria:\n\n* HIV-positive\n* age 16-29 years\n* self-reported proficiency in reading and understanding English.\n* PHQ9 score of 9-17 and impairment in functioning (consistent with clinical depression)\n\nExclusion Criteria:\n\n* pregnant or nursing\n* in care and on ART for \\\u003C6 months\n* history of- or positive assessment for- bipolar or psychotic disorder.","29 Years",{"count":181,"type":22},[25],"Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress.",[601,117,28],"Hiv","2026-07-01",{"date":553,"type":38},{"date":605,"type":38},"2026-01-09",{"date":607,"type":22},"2026-08-30",{"name":609,"class":44},"Massachusetts General Hospital",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":616,"maxAge":392,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":618,"briefSummary":619,"conditions":620,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":626,"locationsCount":45},"100516259","development-and-testing-of-imhere4u-a-digital-suicide-prevention-intervention-for-cyberbullied-adolescents-100516259","NCT06002191","Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents","Inclusion Criteria:\n\n* English-speaking\n* access to a phone or device capable of text messaging\n* past 3-month history of cyberbullying assessed by the cybervictimization subscale of the Traditional Bullying and Cyberbullying Victimization and Perpetration Scale and\u002For presence of online discrimination measured by a modified version of a discrimination measured developed as part of the Adolescent Brain and Cognitive Development (ABCD) study\n* past 3-month history of suicidal risk, including: psychological distress (\\>13 on the 6-item Kessler Psychological Distress Scale) and\u002For suicidal ideation or behavior (via the Columbia Suicide Severity Rating Scale)\n\nExclusion Criteria:\n\n* intellectual challenges, low literacy levels, or other conditions that might inhibit adolescents' ability to effectively engage with Flourish (reported by parents and, if needed, confirmed through the age-appropriate Wechsler Intelligence scale)\n* acuity levels suggesting need for a higher level of care (e.g., inpatient hospitalization) or referral for emergency services","12 Years",{"count":181,"type":22},[25],"The objective of this study is to test the feasibility and preliminary efficacy of Flourish (formerly referred to as imHere4U), a digital suicide prevention intervention for cyberbullied adolescents.\n\nThe specific aims are to:\n\nAim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs. Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, \\>35% underserved youth).\n\nH2a. Primary outcome: Feasibility will be evidenced by recruitment\u002Fretention rates \\> 80% and imHere4U engagement \\> 70%.\n\nH2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and reduced distress and suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up period.\n\nExploratory Aim: Examine the feasibility of delivering feedback on online interactions from machine learning algorithms. All youth assigned to Flourish may optionally provide their social media data to receive feedback from machine learning algorithms. H3a. Feedback from algorithms will have high acceptability (identified via qualitative themes and \\>70% acceptance rates) and usability, defined by mean scores on Post-Study System and Usability Questionnaire (PSSUQ) \\> 6.",[28,621],"Suicidal Ideation",{"date":553,"type":38},{"date":624,"type":38},"2023-11-21",{"date":252,"type":22},{"name":627,"class":44},"University of Pittsburgh",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":632,"acronym":633,"eligibilityCriteria":634,"healthyVolunteers":83,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":23,"phases":637,"briefSummary":638,"conditions":639,"keywords":641,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":45},"100641714","italian-yolo-a-web-based-act-mental-health-promotion-intervention-for-university-students-100641714","NCT07654569","Italian YOLO: A Web-Based ACT Mental Health Promotion Intervention for University Students","YOLO","Inclusion Criteria:\n\n* University Students\n\nExclusion Criteria:\n\n* Not enrolled in university",{"count":636,"type":22},1000,[25],"The mental health of university students requires urgent attention, as many students are exposed to increased risk of psychological distress, including symptoms of depression, anxiety, academic stress, and reduced well-being. Although many students experience mental health difficulties, most do not seek help. University counselling and health services may also face increasing demand and limited resources to meet students' needs.\n\nAcceptance and Commitment Therapy (ACT) is a transdiagnostic psychological approach that aims to increase psychological flexibility. Rather than focusing only on symptom reduction or problem solving, ACT helps individuals develop a more flexible relationship with difficult thoughts and emotions, clarify personally meaningful values, and engage in committed action. However, access to traditional psychological interventions may be limited by long waiting lists, time constraints, conflicts with academic schedules, high costs, stigma, and shortages of trained professionals.\n\nWeb-based interventions may help reduce these barriers by providing accessible and flexible support that students can complete privately and at their own pace. Previous research suggests that ACT can be effectively adapted to online formats and may improve mental health and well-being outcomes in university student populations.\n\nThe present study aims to evaluate the effectiveness of the YOLO web-based ACT intervention among students at the University of Bologna. Participants will be allocated to either immediate access to the YOLO program or a waitlist\u002Fdelayed intervention condition. Outcomes will be assessed at baseline, post-intervention, and follow-up assessments, including psychological flexibility, depression, anxiety, psychological well-being, academic performance, academic self-efficacy, resilience, and purpose in life. The study will examine whether changes in psychological flexibility are consistent with the theoretical basis of the program. It will also assess the feasibility, acceptability, and usability of the intervention to inform its potential dissemination in other Italian higher education contexts. In addition, exploratory analyses will examine caregiving responsibilities among students with caregiving roles and assess whether caregiving demands are associated with mental health, well-being, and academic functioning.",[28,271,640],"Academic Stress",[642],"Italian YOLO",{"date":644,"type":38},"2026-06-22",{"date":646,"type":22},"2026-06-11",{"date":648,"type":22},"2028-12-31",{"name":650,"class":44},"University of Bologna",{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":83,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":23,"phases":659,"briefSummary":660,"conditions":661,"keywords":665,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":45},"100642634","self-help-plus-sh-for-stress-reduction-in-social-service-workers-a-pilot-rct-100642634","NCT07644949","Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT","Feasibility and Preliminary Effectiveness of WHO Self-Help Plus (SH+) for Stress Reduction Among Social Service Workers: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Currently employed (permanent, contracted, or temporary staff) at an institution under the Istanbul Provincial Directorate of Family and Social Services\n* Able to read and write in Turkish\n* Willing to participate voluntarily\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Imminent suicide risk, screened at baseline (T0) via PHQ-9 item 9; participants scoring 2 or higher are not enrolled and are immediately referred to a mental health professional\n* Active psychosis, severe substance use disorder, or severe intellectual disability\n* An acute medical condition that would preclude participation\n* Planned extended leave (e.g., maternity or unpaid leave) during the study period",{"count":87,"type":22},[25],"This is a two-arm, stratified cluster-randomized controlled pilot trial evaluating the feasibility and preliminary effectiveness of the World Health Organization's Self-Help Plus (SH+) intervention for stress reduction among social service workers employed by the Istanbul Provincial Directorate of Family and Social Services (ASHP). Four institutions (clusters) are randomized 1:1, stratified by service type, to receive either SH+ plus Enhanced Care as Usual (ECAU) or ECAU only, with a target of 50 participants (25 per arm). The primary aim is to assess feasibility indicators (recruitment, session attendance, retention, and acceptability) to inform a future full-scale definitive trial. Preliminary effects on perceived stress and related mental health and well-being outcomes are examined as secondary outcomes.",[662,663,28,664],"Stress, Psychological, Occupational","Stress, Psychological","Burnout, Professional",[666,667,668,669,670,671,672,673,674],"Self-Help Plus","SH+","social service workers","universal prevention","cluster randomized trial","pilot study","Acceptance and Commitment Therapy","Turkey","social care workers","2026-06-09",{"date":677,"type":38},"2026-06-12",{"date":679,"type":22},"2026-07",{"date":681,"type":22},"2026-11",{"name":683,"class":44},"Istanbul Medeniyet University"]