[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659864":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":44,"studyPopulation":34,"armGroups":45,"interventions":56,"overallOfficials":62,"centralContacts":67,"locations":34,"responsibleParty":76,"collaborators":79,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":34,"enrollmentInfo":99,"targetDuration":34,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":114,"whyStopped":34,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":34},{"fullName":5,"class":6},"Unidade Local de Saúde de Coimbra, EPE","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Change in severity of obsessive-compulsive symptoms (Y-BOCS-II)","This outcome is assessed using the gold-standard Yale-Brown obsessive-compulsive scale-second edition (Y-BOCS-II).It is a clinician-administered scale comprising 10 items (five assessing obsessions, five assessing compulsions), each rated from 0 to 5. Subscale scores range from 0 to 25, yielding a total score range of 0 to 50, with higher scores indicating greater severity of obsessive-compulsive symptoms: non-\u002Fsub-clinical (0-14), mild (15-21), moderate (22-34), severe (35-50). Validation in a portuguese cohort (Castro-Rodrigues, Front Psychiatry. 2018) defined a diagnostic threshold: scores ≥13 indicate the presence of obsessive-compulsive symptomatology consistent with an OCD diagnosis. Scores below this value suggest the absence of clinically significant OCD.","To be administered once a week, throughout the 9 weeks of intervention (baseline until week 9).",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Change in well-being status (WHO-5 Well-Being Index)","This outcome is assessed using a PROM (self-report instrument Patient Reported Outcome Measure) comprising 5 items, each rated on a 6-point scale from 0 (\"at no time\") to 5 (\"all of the time\"), over the preceding two weeks. The raw score, obtained by summing the 5 items, ranges from 0 to 25 and is then multiplied by 4 to yield a percentage score ranging from 0 to 100, with higher scores indicating better well-being. A cut-off under 50 is usually indicative of depression.","To be administered at baseline, at mid-intervention (week 4 out of 9), and at end of study (week 9).",{"measure":19,"description":20,"timeFrame":21},"Change in functionality\u002Fdisability status (WHODAS 2.0)","This outcome is assessed using a PROM (self-report instrument, Patient-Reported Outcome Measure) through the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), based on the World Health Organization's International Classification of Functioning, Disability and Health (ICF) model. It is a 36-item instrument that assesses functioning and disability across six life domains: cognition, mobility, self-care, getting along with others, life activities, and participation. Each item is rated on a 5-point scale from 0 (\"no difficulty\") to 4 (\"extreme difficulty\u002Fcannot do\"). Using simple scoring, item scores are summed to produce a total score ranging from 36 to 180, as well as domain-specific scores, with higher scores indicating greater functional impairment\u002Fdisability.","To be administered at baseline and week 9 (end of study).",{"measure":23,"description":24,"timeFrame":25},"Change in Patient Perception of Patient Centeredness Questionaire (PPPC)","This outcome is assessed using the Patient Perception of Patient Centeredness Questionaire (PCCP), a self-report instrument PROM originally developed by Moira Stewart and colleagues and culturally adapted and validated into European Portuguese, designed to assess the patient's perception of person-centered care received during a clinical consultation. The questionnaire evaluates three core dimensions of the person-centered clinical method: exploring the patient's health, illness, and experience of illness; understanding the whole person; and finding common ground regarding management. Items are rated on a Likert-type scale. We will use the Portuguese version of the questionnaire (Macedo et al., 2019), which showed good psychometric properties.","Baseline and end of study (week 9).",{"measure":27,"description":28,"timeFrame":29},"Feasibility and Engagement metrics (DWAI)","Feasibility will be assessed through initial adherence and retention, engagement (number of daily\u002Fweekly\u002Ftotal hours of platform use, number of materials consumed per week\u002Fin total, consistency of use), and explanatory factors (facilitators and barriers to adherence). These variables will be assessed using platform-collected data (adherence and engagement metrics) and individual interviews with participants. Exclusive to the intervention group.","During the study, and at week 9 (end of study; interviews).",{"measure":31,"description":32,"timeFrame":33},"Acceptability","Acceptability will be assessed through participants' perception of the intervention (usability, usefulness, and satisfaction) using self-report questionnaires (PROMs) administered after completion of the program (quantitative method; Digital Working Alliance Inventory, Goldberg, 2022) and individual interviews with participants (qualitative method). The Digital Working Alliance Inventory (DWAI; Henson et al., 2019) is a 6-item measure adapted from the Working Alliance Inventory (WAI) that assesses the therapeutic alliance between the user and the digital platform across three domains- Goal, Task, and Bond (two items each). Items are rated on a 7-point Likert-type scale from 1 (\"strongly agree\") to 7 (\"strongly disagree\"), yielding a total score range of 6 to 42. Validation of the DWAI for the Portuguese population will be conducted as part of the study. Exclusive to the intervention group.","At week 9 (end of study).",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","Participants will be randomized based on age, sex, illness duration, and current clinical severity at study entry, into two matched groups: Intervention Group, which will receive Standard Therapy (psychiatry + psychology) in addition to the Study Intervention (a digital mindfulness-based cognitive-behavioral therapy program), and Control Group which will receive Standard Therapy alone (psychiatry + psychology).","SUPPORTIVE_CARE",{"masking":41,"maskingDescription":34,"whoMasked":42},"SINGLE",[43],"OUTCOMES_ASSESSOR","The primary objective of this study is to evaluate the efficacy of a digital mindfulness-based cognitive-behavioral therapy program in reducing symptoms of Obsessive-Compulsive Disorder. The secondary objectives regarding this digital mindfulness-based cognitive-behavioral therapy program are to evaluate its impact on users' functionality, users' well-being index, as well as its feasibility and acceptability.\n\nThis is a prospective, randomized, outcome assessor-blinded study. Participants recruited at ULS de Coimbra and Family Health Unit Fernão Magalhães will be invited to participate, preferably during their psychiatry, psychology, or family medicine appointment. The remaining participants will be recruited by telephone (patients on the waiting list) through flyers disseminated on social media, and will only be enrolled in the study following an in-person evaluation by a psychiatrist, in order to confirm the diagnosis of Obsessive-Compulsive Disorder and all inclusion criteria. All volunteers will be given an explanation of the study's purpose and the main aspects related to informed consent. Volunteers who agree to participate will be asked to access a link via their smartphone or personal computer (https:\u002F\u002Foblivia.app), where they will be able to register using their e-mail address. On this platform, they will find a mindfulness-based cognitive-behavioral therapy program, specifically designed for Obsessive-Compulsive Disorder and adapted for digital format. Participation in the study lasts 9 weeks (the duration of the intervention program), during which participants will be guided through mindfulness practices (audio recordings), psychoeducational material on strategies for managing their symptoms, and practical tasks (incorporating meditation practices and proactive strategies into their daily routine). The program was developed in accordance with recommendations from the current literature (e.g., Hershfield \\& Corboy, 2013; Hawley et al., 2022; Selchen et al., 2020) by the research team, namely Mariana Marques and Frederica Carvalho (Psychologists and Certified Teachers from the Mindfulness-Based Professional Training Institute at the University of California, San Diego, and from the Oxford Mindfulness Foundation, University of Oxford) and Ana Araújo (Psychiatrist, PhD in the field of Obsessive-Compulsive Disorder). Participation in the study does not interfere with usual clinical practice, as it does not require any additional travel or medical procedures beyond those already scheduled as part of standard clinical care. The \"Being with OCD\" program was designed to be delivered digitally, allowing participants to complete it at home. Should in-person evaluations be required, these will be scheduled according to the participant's usual clinical pathway.\n\nPatients will be randomized into two groups: the intervention group (which will follow standard clinical practice through psychiatry and psychology appointments and will also undergo the mindfulness-based cognitive-behavioral therapy intervention) and the control group, which will follow standard clinical practice alone.\n\nThis study follows a 9-week visit schedule (V0 to V9), beginning with a baseline\u002Fscreening visit and closing with an end-of-study visit at Week 9.\n\nAt V0, eligibility and recruitment procedures take place, followed by informed consent and randomization. Participants undergo a clinical psychiatric evaluation. At this visit, the following questionnaires are applied: the Y-BOCS-II, the WHO-5 Well-Being Index, the WHODAS 2.0 and Patient Perception of Patient-Centeredness Questionnaire - assumed here to reflect further baseline clinical\u002Fsociodemographic characterization instruments.\n\nThroughout the intervention period, the Y-BOCS-II is administered weekly to monitor changes in obsessive-compulsive symptom severity. At V4 (mid-intervention), the WHO-5 is additionally applied to assess well-being at the midpoint of the program. For the intervention group only, the digital mindfulness-based cognitive-behavioral therapy program is delivered weekly from V1 through V9.\n\nAt the final visit, all participants complete the full battery of assessments: the Y-BOCS-II, the WHO-5, the WHODAS 2.0 and Patient Perception of Patient-Centeredness Questionnaire. For the intervention group only, two additional assessments are conducted exclusively at this visit, to overall evaluate the intervention \"Being with OCD\" mindfulness based therapy: the feasibility assessment (engagement metrics and qualitative interviews via the Digital Working Alliance Inventory DWAI) and the acceptability and viability assessment (self-report questionnaires and individual interviews), respectively.\n\nThe use of digital therapies appears to achieve outcomes comparable to in-person psychotherapy, particularly when it involves a restructuring of cognitive-behavioral aspects (i.e., individuals' ways of thinking and acting). However, the widespread adoption and sustained use of digital therapies still face several barriers, including: the scarcity of studies conducted in real clinical settings; the excessive focus of these studies on symptom improvement, with less attention paid to functional level and potential practical benefits; and the limited inclusion of end-users' perspectives (needs and preferences of both patients and clinicians) in the development of this type of solution.\n\nThe present study was designed to overcome these current limitations. Additionally, we aim to test the incorporation of mindfulness-based techniques into standard cognitive-behavioral therapy for Obsessive-Compulsive Disorder, given that this third-generation therapy (mindfulness) has already been shown to reduce rumination, increase acceptance, and improve emotional self-regulation in patients with Obsessive-Compulsive Disorder (Selchen, 2020; Hershfield \\& Corboy, 2013).\n\nShould our digital program for Obsessive-Compulsive Disorder prove effective, it may become a specialized, low-cost, and highly scalable therapeutic tool, thereby helping to ensure broader access to treatment for this psychiatric condition.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Interventional Group","EXPERIMENTAL","The intervention group will receive Standard Therapy (psychiatry + psychology) in addition to the Study Intervention (a digital mindfulness-based cognitive-behavioral therapy program). Participants will be asked to access a link via their smartphone or personal computer (https:\u002F\u002Foblivia.app), where they register using their e-mail address. On this platform, they will find a mindfulness-based cognitive-behavioral therapy program, specifically designed for Obsessive-Compulsive Disorder and adapted for digital format. Participation in the study lasts 9 weeks (the duration of the intervention program), during which participants will be guided through mindfulness practices (audio recordings), psychoeducational material on strategies for managing their symptoms, and practical tasks (incorporating meditation practices and proactive strategies into their daily routine).",[51],"Behavioral: Mindfulness-based cognitive-behavioral therapy digital program",{"label":53,"type":54,"description":55,"interventionNames":34},"Control Group (CRT)","NO_INTERVENTION","Control Group will receive Standard Therapy alone (psychiatry + psychology).",[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":34},"BEHAVIORAL","Mindfulness-based cognitive-behavioral therapy digital program","A digitally-delivered mindfulness-based cognitive-behavioral program, specifically designed for Obsessive-Compulsive Disorder. The program includes 9 weeks, during which participants will be guided through mindfulness practices (audio recordings), psychoeducational material on strategies for managing their symptoms, and practical tasks (incorporating meditation practices and proactive strategies into their daily routine).\n\nELIMINAR ESTA DESCRIÇÃO ACIMA, PARA NÃO FICAR REPETIDO?",[47],[63],{"name":64,"affiliation":65,"role":66},"Ana I Araujo, MD, PhD","Unidade Local de Saude de Coimbra","PRINCIPAL_INVESTIGATOR",[68,74],{"name":69,"role":70,"phone":71,"phoneExt":72,"email":73},"Clinical Trials Unit do Centro Académico Clínico de Coimbra CTU-CACC","CONTACT","+351 239 400 400","8408","ctu-cacc@ulscoimbra.min-saude.pt",{"name":75,"role":70,"phone":71,"phoneExt":72,"email":73},"Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC",{"type":66,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Ana Isabel Araújo","Ana Isabel Araujo (Psychiatrist), MD, PhD",[80,82,85,87],{"name":81,"class":6},"University of Coimbra",{"name":83,"class":84},"Coimbra Institute for Clinical and Biomedical Research","UNKNOWN",{"name":86,"class":84},"Institute of Psychological Medicine (IPM) of the Faculty of Medicine",{"name":88,"class":84},"CIBIT - Coimbra Institute for Biomedical Imaging and Translational Research","100659864","a-digital-mindfulness-based-program-for-ocd-100659864",false,"NCT07871344","A Digital Mindfulness-Based Program for OCD","Being With OCD: A Digital Mindfulness-Based Cognitive-Behavioral Program for Obsessive-Compulsive Disorder","MBCT-OCD","Inclusion Criteria:\n\n* Adults (\\>18 years old) diagnosed with Obsessive-Compulsive Disorder, recruited from the corresponding outpatient clinic of the Psychiatry CRI (Responsibility Center for Integration) at ULS de Coimbra (Coimbra Local Health Unit), preferably from the waiting list, currently in follow-up care, or recruited from the community.\n\nExclusion Criteria:\n\n* Low digital literacy or lack of the resources required for participation (smartphone or computer with internet access); history of other severe neuropsychiatric conditions (such as epilepsy, severe traumatic brain injury, cognitive impairment); significant language, vision, or hearing impairments; alcohol, drug, or other substance abuse.","ALL","18 Years",{"count":100,"type":101},128,"ESTIMATED","INTERVENTIONAL",[104],"NA","Obsessive-Compulsive Disorder (OCD) is a common long-lasting, and disabling condition, affecting 1 in every 25 people in Portugal. People with OCD experience unwanted, repeated thoughts (obsessions) and repetitive behaviors (compulsions) that impair their daily lives and well-being. Even though OCD is common, many people do not get the specialized help they need. On average, it takes about 10 years from when symptoms first appear until someone receives proper treatment. This happens mainly because specialized care is mostly available in central hospitals, which makes it harder for people living outside big cities to get help. This delay is caused by a mix of factors: distance from specialized centers, financial barriers, and the stigma that still surrounds mental illness. These are well-known problems, and they highlight the urgent need for treatment options that are easier to access and can reach more people.\n\nThe \"Being with OCD\" study aims to test whether an online program - combining cognitive-behavioral therapy (a well-established talk therapy approach) with mindfulness techniques - can effectively help people with OCD. Digital tools like websites and phone apps have become a promising way to make mental health care more available, more affordable, and easier to reach for more patients.\n\nRecent research shows that online cognitive-behavioral therapy programs for OCD can meaningfully reduce symptoms, working about as well as in-person therapy - especially when patients get some support from a clinician along the way. That said, these digital tools have not been tested enough in real-world, everyday settings, and few have been developed by actually listening to what patients and healthcare professionals need. This is a problem because it leads to low engagement by patients in these programs. In fact, a common pattern has been observed: people tend to start using digital therapy programs enthusiastically, but usage drops off quickly after the first few weeks - largely because these programs are not designed around what users actually want and need.\n\nAt the same time, mindfulness - the practice of paying attention to the present moment without judgment - has become an increasingly valuable tool to cognitive-behavioral therapy for OCD. This combined approach can help reduce excessive worrying\u002Foverthinking, increase acceptance of difficult thoughts, and improve emotional control, helping people relate to their intrusive thoughts in a calmer, less reactive way. Among the different types of therapy available, mindfulness-based approaches tend to work particularly well in digital formats, with people sticking with them more and reporting higher satisfaction. For this reason, beyond testing whether our program works, this study will also look at how practical and well-received the program is for users.\n\nWe will recruit 128 patients with OCD, split into two groups: a control group, who will continue receiving their usual care, and an intervention group, who will receive the online program in addition to their usual care. The program will be delivered through a website\u002Fapp (usable on a computer or smartphone) and will run for 9 weeks, offering audio recordings, educational materials, and practical exercises based on cognitive-behavioral therapy and mindfulness. The goal is to help patients change unhelpful thought patterns and behaviors linked to their condition. Throughout the 9 weeks, participants will complete some tests and interviews so the research team can track changes in symptom severity, well-being, day-to-day functioning, and how practical and acceptable the program is to use.\n\nIf this online program proves effective and usable, it could help expand access to OCD treatment for people who currently struggle to find care.\n\nTesting whether this kind of program is practical, well-received, and effective is an important step toward developing new mental health care options that are both clinically effective and genuinely accessible.",[107],"Obsessive-Compulsive Disorder (OCD)",[109,107,110,111,112,113],"Cognitive-Behavioral Therapy","Psychiatric disorder","Mindfulness-based intervention","Digital therapeutics","Psychoeducation","NOT_YET_RECRUITING","2026-10-06",{"date":117,"type":118},"2026-10-13","ACTUAL",{"date":120,"type":101},"2027-03-01",{"date":122,"type":101},"2028-12-31",{"name":5,"class":6}]