Mental Health

184

Review clinical trials related to Mental Health. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

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Status: Not yet recruiting

A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...

Background: As of 2021, almost 45 million people in the United States were foreign-born immigrants. South Asians, including people from Bhutan, are the fastest-growing immigrant subgroup in the US. Their income and education levels are higher than the US average. Yet they have worse physical and mental health outcomes than their White US-born counterparts. These risks include type 2 diabetes and obesity. Objective: This natural history study will explore how life experiences and environmental factors affect heart health and metabolism among Bhutanese people living in the US. Eligibility: Adults aged 18 years or older who identify as Bhutanese and live in the US. Design: Participants will be recruited and screened by the Bhutanese Community of Central Ohio (BCCO). They will have 1 visit to the BCCO s Arogya Clinic in Reynoldsburg. The visit will last 2 hours. Participants will take a survey; they may use either English or Nepali. They will answer questions about their background; their experiences living in the US; and how their customs and habits might have changed. They will also be asked about their experiences with discrimination; their mental health and well-being; their community; quality of life; and overall physical health. The survey will take 60 minutes. Participants will also speak with a researcher. They will be asked how they feel about providing biological samples; these may include saliva, blood, and urine. Their answers will be audio recorded.

Participants needed: 50
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: National Institute of Environmental Health Sciences (NIEHS)Updated: Oct 13, 2026Locations: 1
Eligibility criteria

Adults (aged 18 years and older) living in the United States [+2]

Any South Asian participants that do not identify as Bhutanese. [+1]

Status: Recruiting

Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France

Women seeking asylum (WSA) are overexposed to sexual violence (SV) in their countries of origin, along migration routes, and within host countries. This overexposure does not cease upon arrival in host countries; on the contrary, the first months following arrival are characterised by heightened vulnerability, with an increased incidence of sexual violence, particularly among women with a prior history of victimisation. Sexual violence has major consequences on physical health, mental health, quality of life, and healthcare utilisation, and generates substantial individual and societal costs. International organisations, including the United Nations High Commissioner for Refugees, have identified the prevention of sexual violence and the improvement of care for survivors as public health priorities. Previous work suggests that addressing sexual violence within primary care, when embedded in a comprehensive, culturally informed, and coordinated approach integrating medical, psychological, social, and medico-legal dimensions, may contribute to preventing the occurrence or recurrence of sexual violence in host countries. However, no comparative study has yet evaluated the effectiveness of such a coordinated model of care on the prevention of sexual violence among women seeking asylum, nor assessed its efficiency or transferability. The primary objective of this study is to evaluate the effectiveness of a coordinated, transcultural, multidisciplinary outpatient care model on the prevention of sexual violence occurring in host European countries among women seeking asylum.

Participants needed: 675
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Assistance Publique Hopitaux De MarseilleUpdated: Oct 13, 2026Locations: 6
Eligibility criteria

Woman seeking asylum in France [+4]

Re-examination of a previous asylum application. [+1]

Status: Recruiting

Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation

This study examines online programs for parents navigating divorce or separation. Researchers will study whether a self-guided mindfulness app called Healing Hearts, followed by a self-guided online parenting program called the electronic New Beginnings Program, is feasible and acceptable to parents and shows promising effects on parent and child wellbeing. Ninety-six parents who live in the United States, have a child aged 6 to 18 with a former partner, and report mild to moderate psychological distress will be randomly assigned to one of three groups: Healing Hearts followed by the parenting program, the parenting program alone, or a set of online educational resources. Participants complete online assessments before assignment, about seven weeks later, and about seven weeks after the second assessment. The study measures parent wellbeing, parenting, parent reports of child behavior, program use, and participant experiences. All participation takes place remotely.

Participants needed: 96
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of ConnecticutUpdated: Oct 13, 2026Locations: 1
Eligibility criteria

Age 18 years or older. [+6]

Low-speed internet. [+5]

Status: Recruiting

PeerScreen Trial - Reducing Screen Media Use in Peer-groups of Young People

The purpose of the PeerScreen trial is to investigate whether reducing screen media use affects mental health, social interaction, sleep, physical activity, heart rate variability, and behavioral patterns in young people aged 13 to 24 years. The primary question the trial aims to answer is: Does reducing screen media use over a 4-week period improve mental health among young people? Researchers will compare a screen media reduction intervention with a control condition in which participants continue their usual screen media use to determine whether reducing screen media use leads to improvements in mental health. Participants will: * be allocated to either a 4-week screen media reduction intervention or a control condition * complete a study protocol including questionnaire-based assessments, daily self-reports, and objective monitoring of screen media use, sleep, physical activity, heart rate variability, social interactions, and geolocation

Participants needed: 240
Trial details
Age: 13-24Biological sex: AllType: InterventionalSponsor: University of Southern DenmarkUpdated: Oct 13, 2026Locations: 1
Eligibility criteria

Participants must have at least 2 hours/day of self-reported smartphone use duri... [+2]

Participants with no smartphone will be excluded (data from recruitment intervie... [+3]

Status: Recruiting

Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women

In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (STI). Kisumu and Migori counties in Western Kenya have some of the highest HIV/STI incidence in the country. Food insecurity (FI) and poverty are also highly prevalent in Western Kenya. FI and poverty are important drivers of vulnerability to HIV and STIs among AGYW. Poverty alleviation interventions have the potential to reduce STIs and HIV risk among AGYW but, to date, these interventions have reported mixed findings on HIV/STI outcomes, have been primarily targeted at the individual level, and none have focused on agriculture or FI. Therefore, there remains a critical need to develop sustainable, multi-level, economic and FI interventions that improve AGYW STI/HIV prevention outcomes. Our team has successfully developed a household-level agricultural intervention in Western Kenya called Shamba Maisha ("farm life" in Kiswahili; SM) to reduce household FI. In our prior pilot study with AGYW, the investigators found that SM was feasible, acceptable, and associated with less FI and improved mental health. In this proposal, the investigators will build upon our promising SM work by examining the effectiveness and implementation of our SM intervention, including provision of a water pump and agricultural implements for use at home, training in agriculture delivered at school-based demonstration farms, and adolescent-caregiver relationship strengthening training. The investigators plan to conduct this school- and home-based cluster randomized trial with 800 AGYW and their primary caregivers recruited from schools in Kisumu and Migori counties. The investigators will randomize 20 schools in Kisumu and Migori in a 1:1 ratio to intervention or control conditions and follow AGYW-caregiver dyads for 18 months with surveys and STI/pregnancy testing to assess intervention impacts. The study has the following aims: Aim 1. Determine the impact of SM on adolescent HIV prevention and sexual and reproductive health outcomes (primary outcome is gonorrhea and/or chlamydia incidence). Aim 2. Assess the effect of SM on intermediate outcomes theorized from our published conceptual framework to be on the causal pathway, including household food security and wealth, and adolescent and caregiver factors including mental health and aspects of the caregiver-AGYW relationship dyad (e.g., communication). Aim 3. Identify critical implementation facilitators and barriers influencing SM effectiveness and delivery and conduct a programmatic cost assessment. The investigators will also evaluate the extent to which SM can have "spillover" nutritional benefits for a larger population of adolescents who had access to demonstration farms at intervention schools but did not receive other aspects of the intervention. The ultimate goal is to provide an innovative household-level intervention to halt the cycle of FI, and poor HIV-related outcomes among vulnerable populations including AGYW, consistent with the "Ending the HIV Epidemic".

Participants needed: 900
Trial details
Age: 15+Biological sex: AllType: InterventionalSponsor: University of California, San FranciscoUpdated: Oct 8, 2026Locations: 1
Eligibility criteria

AGYW assigned female at birth [+9]

AGYW or adult caregivers who have inadequate cognitive and/or hearing capacity t... [+3]

Status: Recruiting

M3-JIA: Making Mindfulness Matter for Children With JIA

The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their parents will attend an 8 week online program called Making Mindfulness Matter (M3). This is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. The child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level.

Participants needed: 74
Trial details
Age: 4-12Biological sex: AllType: InterventionalSponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUpdated: Oct 9, 2026Locations: 3
Eligibility criteria

Children aged 4 to 12 years diagnosed with JIA [+3]

Other major co-morbid disorders (e.g. Crohn's disease, diabetes, renal failure). [+1]

Status: Recruiting

Effectiveness of the Self-Control Module of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: Protocol for a Randomised Controlled Trial

The primary objective of this study is to evaluate the effectiveness of the self-control module of the Mentis Plus+ Positive Mental Health Promotion Programme for Caregivers (Mentis Plus+ Caregivers), compared with usual care, in improving positive mental health among adult informal caregivers of people with dementia. The secondary objectives are to assess the programme's effectiveness in reducing symptoms of depression, anxiety and stress, as well caregiver burden, compared with usual care.

Participants needed: 108
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Rovira i VirgiliUpdated: Oct 9, 2026Locations: 1
Eligibility criteria

Informal caregivers of non-institutionalised individuals with dementia [+2]

Unable to read and write in Portuguese [+1]

Status: Recruiting

Integrated Digital Psychosocial and Reproductive Health E-Clinic for Women and Adolescent Girls in Jordan

This implementation study evaluates an integrated digital e-clinic designed to provide mental health, psychosocial, and reproductive health support to women and adolescent girls in Jordan, including Jordanian and Syrian refugee participants and other vulnerable groups. The e-clinic provides individualized psychosocial support, evidence-based educational content, self-help resources, scheduled interactions with trained healthcare providers, and referral pathways for participants requiring additional or specialized services. Participants complete baseline assessments before using the e-clinic and follow-up assessments approximately three months after baseline or following completion of the intervention. The study evaluates changes in mental health and well-being outcomes as well as acceptability, appropriateness, feasibility, accessibility, digital health literacy, reproductive health knowledge and attitudes, service utilization, participant satisfaction, privacy, and engagement with the e-clinic.

Participants needed: 250
Trial details
Age: 14-65Biological sex: FemaleType: InterventionalSponsor: Jordan University of Science and TechnologyUpdated: Oct 6, 2026Locations: 1
Eligibility criteria

Female participants aged 14 to 65 years. [+5]

Acute psychiatric or psychological condition requiring immediate specialist or e... [+4]

Status: Not yet recruiting

Neurocomputational Dynamics of Cooperation

The purpose of this study is to understand brain function, how people make decisions when they interact with others, and how brain function and behavior relate to personality traits.

Participants needed: 1,612
Trial details
Age: 18-100Biological sex: AllType: InterventionalSponsor: University of PittsburghUpdated: Oct 6, 2026Locations: 1
Eligibility criteria

English fluency [+3]

Participants who have participated in an earlier version of the study [+18]

Status: Recruiting

Evaluating WhatsOK Helpline for Youth With Concerns About Sexual Thoughts and Behaviors

Research suggests up to 77% of harmful sexual experiences during childhood are caused by other youth. Sometimes called peer-peer abuse or youth-perpetrated child sexual abuse, problematic and harmful sexual behavior among youth (PHSBY) involves sexual behaviors that are not developmentally appropriate and have potential to cause harm to the child or children involved. Compared to adults, children and adolescents who engage in sexual exploration are at greater risk of making mistakes or causing harm, in large part because they have insufficient information about healthy sexual behavior and development, consent, and related concepts. However, the available support, information, and resources for youth who have engaged in or are at risk of engaging in PSHB are limited. To address these unmet needs, Stop it Now! (stopitnow.org) created the first youth-focused website and helpline services (WhatsOK) for young people with concerns about their sexual thoughts, interests, and behaviors. WhatsOK.org is a microsite developed specifically for youth aged 14-21 years. If a child or young person has concerns about their sexual thoughts or behaviors, the WhatsOK Online Help Center and Helpline can provide support and resources to support healthy behavior and prevent problematic or harmful behavior. If someone has already engaged in PHSBY or if they are unsure about whether what has been done is illegal, they can still reach out for confidential help to learn about taking steps to stop. Preliminary findings from a longitudinal, observational study of the WhatsOK helpline suggest that youth are willing to seek out help for their (and others') sexual interests and behaviors, highlighting the critical need for prevention strategies targeting youth with potentially concerning sexual behaviors. We examined the characteristics of contacts to the WhatsOK helpline via data collected from pre-set questions on age, primary reason for contact, timing of inquiry relative to other help-seeking, and timing relative to harm caused. Most inquiries came from youth aged 14 to 21 (57.7%) via email (54.4%). Over half (54.6%) had already engaged in harmful or illegal behaviors or were potentially at risk to do so. The majority of contacts sought help prior to seeking out other external professional resources (54%). The current study is a randomized control trial evaluating the impact of the WhatsOK helpline in reducing PHSBY and improving help-seeking attitudes and behavior in a sample of participants ages 14-17 with concerns about their sexual thoughts and behaviors.

Participants needed: 920
Trial details
Age: 14-17Biological sex: AllType: InterventionalSponsor: Center for Violence Prevention Research IncUpdated: Oct 6, 2026Locations: 1
Eligibility criteria

must be ages 14-17 years at baseline [+2]

Under 14 or over 17 years of age [+4]

Status: Recruiting

SBIR/ STTR Family Check-up Online

The Family Check-Up Online, a digital health intervention, was designed to improve child mental health through family-centered intervention. The Family Check-Up is grounded in over 25 years of evidence-based research and has been shown to improve child mental health and behavior including depression and conduct problems. The investigators were supported by an SBIR Phase I award (R43MH132191) to evaluate the feasibility and acceptability of the digital health product in schools and to adapt the product based on findings of that work. Findings from that project suggested the model is a good fit for schools, with school providers stating a need for family-centered interventions that target child behavior and mental health, but with few resources or evidence-based programs available. The research team received feedback that suggests the model should be evaluated as both an uncoached version and coached version, delivered with provider support. In the current project, the investigators plan to continue work in schools to develop the model for commercialization, including understanding the process for embedding the FCU Online into current student support systems and implementation factors that lead to maintenance of the model in schools. The investigators plan to conduct a hybrid type 2 effectiveness-implementation trial to evaluate the effectiveness of the FCU Online when delivered by real world providers. Thirty providers (N=600 students/families) will be randomly assigned to receive training in the FCU Online coached vs. uncoached models. The research team will then evaluate outcomes including family relationships, parenting skills, and child mental health and behavior. The investigators predict that the FCU Online will improve child mental health and behavior, and will test for moderators such as provider training and child baseline risk. Findings will have implications for commercialization of the product in schools and implementation of the model in a range of different school settings.

Participants needed: 670
Trial details
Biological sex: AllType: InterventionalSponsor: University of OregonUpdated: Sep 29, 2026Locations: 1
Eligibility criteria

A caregiver must have a child between the ages of 11 and 14 enrolled at a partic... [+3]

the caregiver is unable to read in either English or Spanish; or [+1]

Status: Recruiting

Study of Individual Neurocognitive Changes Associated With the Training of the Working Memory.

8 participants including 2 pilots. The 2 pilot participants will each execute an MRI acquisition session in order to adjust the experimental paradigm

Participants needed: 8
Trial details
Age: 18-30Biological sex: AllType: ObservationalSponsor: Centre Hospitalier St AnneUpdated: Oct 1, 2026Locations: 1
Eligibility criteria

age between 18 and 30 years, [+3]

contraindications to MRI, [+3]

Status: Not yet recruiting

Social Contact-Based Brief Video Interventions To Reduce Stigma and ImproVe Engagement in HIV Prevention and Care and Mental Health Care for Youth Living With and Vulnerable to HIV

HIV stigma, poverty, and racism contribute to high rates of mental health problems and impede treatment for young sexually minoritized men living with and vulnerable to HIV. Intersectional interventions can reduce barriers and promote access to health services, thus preventing poor health outcomes including HIV transmission related behaviors. The STRIVE intervention will address public and internalized HIV stigma and thus reduce the duration of untreated HIV and mental health problems among young men living with or vulnerable to HIV.

Participants needed: 3,900
Trial details
Age: 18-30Biological sex: AllType: InterventionalSponsor: City University of New York, School of Public HealthUpdated: Oct 1, 2026
Eligibility criteria

YSMM from the New York area aged 18-30 who are either living with HIV or vulnera...

N/A

Status: Recruiting

SAFEGUARD Level Up Study

This project will evaluate the effectiveness of Level Up: Boost Your Life Skills ("Level Up"), a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal-related behaviors (SRBs) and other harmful behaviors, improve mental health, enhance job performance, and reduce early military separation. The Level Up program components will be made available to participants through an online platform or mobile app that can be downloaded onto their personal mobile devices. These training materials will help Soldiers learn and practice skills. The Level Up program will also involve personalized messages from a Level Up trainer and virtual booster sessions. Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon will be randomized to receive either Level Up or Training as Usual (TAU). Participants will complete baseline and follow up surveys 1, 3, and 6 months post-baseline.

Participants needed: 5,000
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Uniformed Services University of the Health SciencesUpdated: Sep 25, 2026Locations: 1
Eligibility criteria

Active duty Soldiers Active duty Soldiers who are currently stationed at Fort Ho...

Soldiers who are not present at the time of recruitment [+1]

Status: Not yet recruiting

ImprovINg the TIMEly Diagnosis and Treatment of Cancer and Cardio-metabolic Diseases in People With Mental Disorders: Reducing Health Disparities Through Integrated Care

One in five people in Italy has a mental disorder, with depression being the most common and schizophrenia the most severe. People with mental illness have a higher risk of cardio-metabolic and oncologic comorbidities. They also face disparities in accessing appropriate care, with a 20-year life expectancy reduction. IN-TIME will employ an innovative and highly interdisciplinary approach to characterize barriers to healthcare in people with mental illness for informing interventions and enhancing screening, diagnostic pathways and health outcomes. The project will provide: 1) population-based evidence and characterization of disparities in diagnosis and care for cancer and cardio-metabolic disorders; 2) a fine-grained identification of modifiable barriers, such as those relating to stigma and communication; 3) change promoting interventions, including a policy brief to orient clinical guidelines and best practice to reduce stigma, improve doctor-patient communication and optimize care.

Participants needed: 120
Trial details
Age: 40-70Biological sex: AllType: ObservationalSponsor: IRCCS San RaffaeleUpdated: Sep 28, 2026
Eligibility criteria

Age 40-70 years; [+4]

Age <40 years or >70 years. [+2]

Status: Not yet recruiting

Supporting Treatment Access and Recovery in Re-entry (STAR-R)

This application is aimed at testing a multicomponent intervention called "Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) or Peer Linkage Support post-release from two jails in Massachusetts for individuals with co-occurring substance use and mental health disorders (COD), given high rates of COD among incarcerated populations. The research will examine engagement in treatment, behavioral health outcomes, mediators and moderators, an economic analysis, and facilitators and barriers of MISSION-CJ implementation.

Participants needed: 240
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Massachusetts, WorcesterUpdated: Sep 22, 2026Locations: 2
Eligibility criteria

18 years or older; [+3]

Are acutely suicidal based on the CSSRS; or [+1]

Status: Recruiting

RISE Lab: Building Resilience Through Responsibility

RISE Lab: Building Resilience Through Responsibility Specific Aims The goal of this pilot study is to develop, implement, and evaluate RISE Lab (Regulate, Identity, Strengthen, Empower), a small-group Tier 2 intervention that builds self-regulation, responsibility, and resilience among middle school students with behavioral and mental health needs. A two lesson, Cognitive Behavioral Therapy (CBT) aligned sequence on self-regulation from an employability social skills curriculum originally developed for justice-involved youth into a Tier 2 intervention for middle school students with behavioral and mental health needs. This project will accomplish the following aims: Aim 1: Intervention Adaptation (development phase). This study will adapt a two lesson CBT-aligned sequence on Actions, Thoughts, and Feelings and Taking Responsibility into the RISE Lab intervention, designed for middle school students with behavioral and mental health needs. Content will be revised for developmental appropriateness and flexible delivery formats (push-in, pull-out, hybrid) and co-designed with relevant community members. This aim will address the following research questions: 1. How can lessons originally designed for justice-involved youth be adapted for middle school students with behavioral and mental health challenges? 2. What modifications (e.g., language, visuals, delivery format, context, lesson activities) make the lessons more engaging, accessible, and appropriate for middle school students? 3. What do teachers, counselors, parents, and students find most critical for ensuring feasibility in a school setting? Aim 2: Pilot Study (implementation phase). Implement RISE Lab in 6-8 Tier 2 small groups of 4-5 students across two middle schools to assess feasibility, acceptability, and fidelity of implementation. Facilitators will receive training, and students will participate in a multi-session intervention cycle with opportunities for practice, reflection, and generalization. The following questions will be addressed: 1. Is RISE Lab feasible to deliver within a middle school MTSS framework without excluding students from general education instruction? 2. How acceptable do students, teachers, and school mental health staff find the intervention content, structure, and delivery? 3. Can RISE Lab be delivered with fidelity across different facilitators (e.g., counselor vs. SPED teacher) and formats (e.g., push-in vs. pull-out)? Aim 3: Outcomes and Refinement (evaluation phase). Conduct a mixed-methods evaluation of RISE Lab to assess preliminary impacts on student mental health and behavioral outcomes (e.g., self-regulation, responsibility, and resilience) and to gather teacher, student, and family feedback on the intervention. Findings will be used to refine RISE Lab for scalability and readiness for larger-scale efficacy testing in future grants. This aim will address the following research questions: 1. Do students who participate in RISE Lab show improvements in self-regulation, responsibility, and resilience relative to baseline? 2. How do teachers perceive changes in participating students' classroom behaviors (e.g., emotional regulation, peer interactions, accountability)? 3. What does qualitative feedback from students, teachers, and parents suggest about refinement of RISE Lab for acceptability, feasibility, and implementation fidelity? The primary outcome of RISE Lab is acceptability, feasibility, and fidelity of the intervention package with secondary outcomes of improved student self-regulation as measured by taking responsibility, resilience, and improvements in classroom behavior. Project outputs will include an adapted intervention with age-appropriate examples, worksheets, and visuals; a facilitator implementation guide with strategies for effective delivery; training materials; and a pilot feasibility report. Findings will provide the groundwork for a future efficacy trial and broader integration of RISE Lab within school-based MTSS.

Participants needed: 30
Trial details
Age: 11-14Biological sex: AllType: InterventionalSponsor: University of OregonUpdated: Sep 22, 2026Locations: 1
Eligibility criteria

Enrolled in partner middle schools; identified by MTSS/PBIS teams for Tier 2 sup...

Receiving Tier 3 or clinical mental health services; unable to participate in sm...

Status: Recruiting

Study of Mental Health and Relationships

The goal of this clinical trial is to test effects of the Great Life Mentoring (GLM) program on the mental health and adaptive functioning on school-age youth (ages 9-16) from low-income families who are receiving outpatient mental health services. The main questions it aims to answer are: • Does participation in the GLM program improve mental health and related outcomes among school-age youth (9- to 16-years-old) from low-income families as an adjunct to outpatient mental health services? 180 youth will be enrolled in the study and assigned randomly to either continue mental health services as usual (SAU) or to continue mental health services while also participating in GLM (SAU+GLM). Participating youth, and their parent/guardians and therapists, will be surveyed annually. Mental health services records also will be obtained with appropriate permissions. . Researchers will compare the SAU and SAU+GLM groups to see if participation in GLM has an effect on the mental health and related outcomes of study youth.

Participants needed: 180
Trial details
Age: 9-16Biological sex: AllType: InterventionalSponsor: University of Illinois at ChicagoUpdated: Sep 21, 2026Locations: 1
Eligibility criteria

Youth is between 9- and 16-years-old [+1]

Parental primary language other than English [+1]

Status: Not yet recruiting

Qungasvik (Toolbox)-Healthy Hearts: A Cultural Approach to Reducing Chronic Disease Risk

Due to the extreme remoteness, transportation challenges, and lack of access to clinical care, the delivery of preventative health interventions in rural Alaska Native communities is a top tribal priority. Chronic disease and behavioral health contribute to the higher rates of mortality and morbidity experienced in rural Alaska. This study will test the effectiveness of a culturally-grounded, community-delivered preventive intervention, Qungasvik-Healthy Hearts, to reduce risk factors associated with chronic disease and behavioral health in three rural Alaska Native communities. Implementation science outcomes will identify key contextual factors, social determinants and costs associated with health outcomes related to positive change in behavior, blood pressure, diet and physical activity, assessed among 300 participants from the three rural communities.

Participants needed: 300
Trial details
Age: 12+Biological sex: AllType: InterventionalSponsor: University of Alaska FairbanksUpdated: Sep 21, 2026Locations: 1
Eligibility criteria

self-identify as a permanent resident of the study community [+2]

does not have permanent residence in the community [+1]

Status: Recruiting

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

Participants needed: 150,000
Trial details
Age: 1+Biological sex: AllType: ObservationalSponsor: Murdoch Childrens Research InstituteUpdated: Sep 17, 2026Locations: 1
Eligibility criteria

Birth date between 4th October 2021 and 3rd October 2023 [+5]

Children who are deceased at the time of recruitment (i.e. still born or died af... [+1]

Status: Recruiting

Disparities in Mental Health Screening and Support

To develop and administer online surveys to cancer patients and their families across diverse regions within the EU to detect possible disparities in their access to mental health screening and psychological-cognitive support

Participants needed: 2,000
Trial details
Biological sex: AllType: ObservationalSponsor: European Institute of OncologyUpdated: Sep 10, 2026Locations: 1
Eligibility criteria

residence in EU [+9]

NA

Status: Not yet recruiting

Effectiveness and Implementation of a School-based Mental Well-being Intervention Among Adolescents of Bharatpur, Nepal

The goal of this study is to evaluate the effectiveness and assess the implementation of CROSS-MIND, a school-based mental well-being intervention for adolescents in Nepal. The study uses a Hybrid Type 1 mixed-methods design. The main questions it aims to answer are: Does CROSS-MIND improve students' mental well-being, self-esteem, and behavioural and emotional outcomes compared with usual school activities? Is CROSS-MIND acceptable, feasible, appropriate, and delivered with adequate fidelity, and what barriers and facilitators influence its delivery by teachers? For the effectiveness evaluation, classes of grades 6 to 10 in five schools in Bharatpur Metropolitan City will be randomly assigned to receive either the CROSS-MIND intervention or usual school activities. Students will complete questionnaires before and after the intervention. Students in intervention classes will participate in eight weekly storytelling and reflection sessions of approximately 90 minutes, delivered by trained teachers. Qualitative interviews and focus group discussions will also be conducted with selected students, teachers, school principals, and psychologists to explore experiences of the intervention and factors influencing its implementation.

Participants needed: 1,060
Trial details
Age: 11-19Biological sex: AllType: InterventionalSponsor: University of AarhusUpdated: Sep 10, 2026Locations: 1
Eligibility criteria

Students enrolled in grades 6-10 in the participating schools [+2]

Status: Not yet recruiting

Food Menu Labelling Effects on Individuals With Eating Disorders and Other Mental Health Conditions.

Calorie labelling in out-of-home (OOH) settings was introduced by the government in England as part of a wider strategy to 'tackle obesity' (DHSC, 2020). The OOH sector encompasses outlets where food and drinks are prepared for immediate consumption, on or off the premises (DHSC, 2021). Increased consumption of OOH food is associated with greater intake of energy and nutrients of concern; therefore, is implicated in poorer dietary quality and ill-health (Gesteiro et al., 2022). The key ambition for the calorie labelling policy was to inform consumers of the calorie content of their food choices, making it easier to select healthier food choices (DHSC, 2020). An additional potential benefit of the policy was to prompt reformulation by the food industry to either reduce the calorie content of foods on offer or provide new lower calorie options (DHSC, 2021). The calorie labelling policy in England was criticised at the time of implementation in the media for its potential to cause harm in individuals with eating disorders (Polden et al., 2023). However, limited research had explored effects on individuals with eating disorders (Robinson et al., 2023). It is estimated that over a million individuals in the UK are living with an eating disorder (Beat Eating disorders, 2026). Therefore, it is important for research to understand the impact of food labelling interventions on mental health outcomes in individuals with eating disorders and other mental health conditions, and whether alternative nutritional labelling practices that are not focused on calories alone could have positive health impacts without unintended negative consequences. One alternative form of nutritional labelling that could be considered in OOH settings is Nutri-score. Nutri-score provides food items with a label from A (dark green, healthiest) to E (Red, least healthy) according to the content of both positive (e.g. fibre, protein) and negative (e.g. saturated fat, salt, sugar) nutrients. Nutri-score has been implemented as a front-of-pack label in several countries across Europe, with positive impacts on the healthiness of food purchasing in supermarkets (Andreani et al., 2025). Two studies have assessed Nutri-score in OOH settings, also finding associations between Nutri-score and healthier food choices (Chandon \& Indaburu, 2026; Julia et al., 2021). However, Nutri-score on food menus has not previously been examined in terms of the potential impact on individuals with eating disorders and other mental health outcomes. Nutri-score encompasses the nutritional quality of a food product, by accounting for both positive and negative components. This may be less harmful to individuals with eating disorders as it would remove the focus on calorie content. Previous qualitative research has shown that individuals with eating disorders may support labelling strategies that provide more holistic approaches to nutrition (Trompeter et al., 2026). It could also be of benefit to general population health to focus on helping individuals to consume a well-rounded diet higher in positive nutrients (fibre, protein), with high fruit, vegetable and nut content, and lower in negative nutrients that contribute to ill health (salt, sugar, fats). To date, limited research has compared Calorie labelling to Nutri-score in the general population or among those living with mental health conditions, like eating disorders. OBJECTIVES This new study will explore the impact of Nutri-score labelling vs Calorie labelling vs no labelling (Control) in a simulated OOH food delivery ordering platform (common setting for food purchasing and calorie labelling is required by law in England) on participants' perceived effectiveness of nutritional labelling, healthiness of food choices, positive and negative affect, and perceived impacts on mental health. We will examine effects in a general population sample (no eating disorder diagnosis), a sample of participants with a past or current diagnosis of an eating disorder by a medical practitioner and a sample of participants with a common mental health condition diagnosed by a medical practitioner without eating disorder (e.g., anxiety), in order to understand potential effects across groups of participants who may differ in their risk of poorer mental health in response to nutritional labelling. (references in attached protocol)

Participants needed: 900
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of LiverpoolUpdated: Sep 9, 2026Locations: 1
Eligibility criteria

Residing in the UK [+7]

Pregnant/breastfeeding [+1]

Status: Recruiting

Improv Comedy to Reduce Anxiety and Improve Mental Well-Being in Young Chinese Adults in Hong Kong

The goal of this clinical trial is to learn if improv comedy helps reduce anxiety symptoms and improve mental well-being in Chinese young adults in Hong Kong. The main questions it aims to answer are: 1. Does improv comedy reduce anxiety symptoms? 2. Does improv comedy improve mental well-being? Researchers will compare participants who join the improv comedy workshops to participants who are placed on a waiting list to receive the workshops later, to see if improv comedy reduces anxiety and improves mental well-being. Participants will: 1. Attend weekly three-hour improv comedy workshops for 4 consecutive weeks 2. Complete four assessments and brief reflections during or around the workshop sessions 3. Take part in up to two individual interviews (optional)

Participants needed: 150
Trial details
Age: 18-29Biological sex: AllType: InterventionalSponsor: The University of Hong KongUpdated: Sep 4, 2026Locations: 1
Eligibility criteria

Ethnic Chinese, fluent in spoken Mandarin and able to read Chinese [+5]

Unstable or severe chronic physical illness that would contraindicate participat... [+3]

Status: Recruiting

Improving School Climate and Children's Well-being Through the Life Skills "Feel Good" Intervention in French Schools: A Controlled Before-and-After Study

Life skills are major determinants of health that can be influenced through health promotion initiatives. Numerous educational interventions exist to foster the development of life skills. However, few interventions have been validated in France. The Feel Good program has been implemented for six years by CRIPS Île-de-France, particularly to address these public health challenges related to promoting children's health. Its goal is to improve life skills and the school climate among children in the 4th and 5th grades (CM1 and CM2). A playful, interactive, and recurring approach to developing PSS at school is expected to effectively promote a positive school climate and enhance children's well-being at school. The main objective of this study is to evaluate the effectiveness of a school-based life skills development program in improving school climate and children's well-being, through a before-after, here-elsewhere (control group) design. This action-research project adopts an interdisciplinary approach and will use mixed methods to evaluate the intervention. Three components are planned: 1) the study of implementation, 2) the effectiveness evaluation (main objective), and 3) the development of recommendations for the development and evaluation of such interventions. A theoretical model of change has been developed for the effectiveness study, aligned with process data. The project has received ethical and regulatory approvals (UPC and Inserm), and a pilot study has already been conducted. The expected outcomes include scientific knowledge on the validity of health promotion programs based on the development of life skills for children. The project also aims to develop research methodologies for evaluating health promotion interventions (evidence-based data) and to establish recommendations (replicability), as well as for other themes or populations (transferability).

Participants needed: 1,500
Trial details
Age: 8-12Biological sex: AllType: InterventionalSponsor: Université Paris CitéUpdated: Sep 4, 2026Locations: 1
Eligibility criteria

Children enrolled in grades 4 or 5 during the 2025-2026 school year who will par... [+2]

Children not enrolled in grades 4 or 5 during the 2025-2026 school year who will... [+2]