Clinical Research Directory

Future School of Comprehensive Well-Being

Good physical, mental and social health, particularly in childhood and early adolescence, are powerful predictors of positive life trajectories. Contrary to this, problems in these domains expose individuals to negative developmental trajectories. Schools are ideal settings to address these issues due to their incisiveness and long-term impact. However, school-based well-being interventions are not designed to be ingrained in basic pedagogical processes of school, this is, learning, teaching and studying. In this study the effects of a school-based pedagogically ingrained comprehensive well-being trial will be studied, involving curriculum embedded socio-pedagogical activities, designed to cultivate simultaneously learning and their mental, social and physical well-being. In the Future School of Comprehensive Well-Being (SchoolWell) Comprehensive wellbeing pedagogy intervention for primary and lower secondary school students: rationale and study protocol for the SchoolWell cluster randomized controlled trial -study the investigators use a cluster randomized hybrid type 1 effectiveness-implementation design. SchoolWell involves 10 Finnish speaking Teacher Training Schools including both primary and secondary schools. Randomization occurs at the school level. The intervention is a multicomponent implementation strategy that has been co-designed by SchoolWell research team and case schools' teachers. All 5th and 8th graders (aged 11-12 years and 14-15 years), from the control and intervention schools are eligible for the study. Total of 1440 students (560 5th and 880 8th graders) will be recruited for the study (n=717 students from intervention schools and n=723 students from control schools). Data is collected from Grade 5 and 8 students representing schools randomized to experimental (n=5) and control condition (n=5). The control group in Year 1 remains on the waitlist until the start of Year 2, when the second cohort of the experiment (low support condition) for these schools begins. The purpose of the low support condition is to examine whether intervention effects can be achieved with less support than in the high support condition, where researchers are more actively involved. Schools allocated to the intervention group deliver weekly SchoolWell activities over the full school year as part of the regular curriculum. The activities include socio-pedagogical activities, these are modes of teaching, learning and studying, promoting student mental, social and physical well-being as well as learning aligned with regular curriculum goals. Intervention schools have access to six implementation support strategies in addition to the training received as usual delivery to build knowledge and skills. Implementation and effectiveness outcomes are assessed using weekly online surveys, interviews at baseline T0 (8/2024), T1 (11/2024), T2 (4/2025) and at 19-month follow-up (T3; 4/2026) and four dialogues with teachers. Semi-structured interviews with teachers and support staff will be used to examine which implementation strategies worked for whom and under what conditions. The primary outcome is study engagement. Secondary outcomes include measures on learning, mental, social and physical well-being. Economic and process evaluations will also be conducted to determine cost-effectiveness, program acceptability, implementation, adaptability, and sustainability in schools. SchoolWell draws on the Consolidated Standards of Reporting Trials (CONSORT) and the Standards for Reporting Implementation Studies (StaRI) in evaluating the SchoolWell intervention. Also, the Consolidated Framework for Implementation Research (CFIR) is used to guide support strategies. The CFIR provides constructs that have been associated with effective implementation (intervention, outer settings, inner settings, individuals, implementation process). Subsequently, the Proctor's framework is followed to evaluate the implementation process. The framework stands for acceptability (treatment is agreeable or satisfactory), adoption (intention to employ an innovation or evidence-based practice), appropriateness (fit of the innovation to address a particular issue or problem), cost (cost impact of an implementation effort), feasibility (extent to which a new treatment can be successfully carried out in given setting), fidelity (extent how intervention is delivered as intended), penetration (number of providers who deliver treatment), and sustainability (extent to which a newly implemented treatment is maintained). Hypotheses are: H1. SchoolWell 1 intervention will have a positive effect on student-level outcomes (8- and 19-month post-tests). H2. The multidisciplinary intervention enhances both learning and mental, physical, and social well-being.

PREWELL Digital Well-being Promotion Intervention With the BitHabit App

Mental wellbeing is a major public health concern, and digital interventions have emerged as a scalable approach for promoting mental well-being and healthy lifestyle behaviors. However, evidence regarding long-term effectiveness and the role of user engagement remains limited. This study evaluates the effectiveness of the BitHabit digital wellbeing application in promoting mental wellbeing and healthy lifestyle among adults living in North Savo, Finland. The BitHabit application is a digital behavior change intervention designed to support mental wellbeing through the adoption of small, self-selected wellbeing-promoting habits. The application incorporates principles of self-determination theory, habit formation, self-monitoring, and behavior change techniques. Participants select habits from a library of well-being-promoting activities and track their implementation over time. The intervention study uses a stepped-wedge randomized controlled design in which all participants eventually receive access to the intervention, while participants awaiting access serve as controls. Adults aged 18 to 64 years living in North Savo were recruited between 2024 and 2025 through population registry sampling and open public recruitment. Following informed consent and baseline assessment, participants were randomly allocated to receive access to the intervention at different time points during the study. Power calculations using Monte Carlo simulations indicated that approximately 1,600 participants would provide 80% power to detect a standardized mean difference of 0.30 in mental wellbeing (SWEMWBS), assuming four intervention sequences, five measurement occasions, a within-person intraclass correlation coefficient of 0.70, and 30% attrition. The primary outcome mental wellbeing is assessed using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). Secondary outcomes include depressive symptoms measured with the Patient Health Questionnaire (PHQ-9), self-reported capabilities, loneliness measured with the UCLA 3-item Loneliness Scale (UCLA-3), life satisfaction measured on a 0-10 scale, and self-reported health behaviours. Outcomes are measured at baseline and repeated follow-up assessments throughout the study. We hypothesize that participants receiving the intervention will show greater improvement in all primary and secondary outcome measures compared with the control condition. App usage data are used to evaluate intervention adoption and engagement and to examine whether effectiveness differs according to actual intervention use. Statistical analyses will be conducted using mixed-effects regression models that account for the stepped-wedge design and repeated measurements within participants. Models will include fixed effects for intervention exposure and time, and a random intercept for participants. Estimates will be reported with 95% confidence intervals and a two-sided significance level of 0.05. In addition to quantitative outcome assessments, participant experiences and acceptability of the intervention will be evaluated with user satisfaction questionnaires and qualitative interviews conducted among a subset of participants. These data will be used to assess perceived usefulness, user experiences, and opportunities for further development of the intervention. In addition to questionnaire and app usage data, participants will be linked to regional and national administrative registers. Register-based follow-up covers the period from one year before study enrolment until up to ten years after study completion. Data sources include health and social care registers, prescription and reimbursement registers, employment-related registers, and population registers. These data will be used to evaluate the long-term effectiveness and cost-effectiveness of the intervention, including health service use, medication use, social outcomes, and associated costs.

Friendship Bench for Women Who Use Methamphetamine in Vietnam

The high comorbidity of mental health issues and meth use in women worsens both their mental health and meth use outcomes. The study team proposes to evaluate the potential of Friendship Bench to be used as a low-threshold, task-shifting mental health intervention among women who use methamphetamine in Vietnam - a lower-middle-income country. The study will provide preliminary data for a R01 trial testing the effectiveness Friendship Bench to improve mental health and methamphetamine use outcomes among women who use methamphetamine in Vietnam.

Transdiagnostic Online CBT vs. Care as Usual for Primary Care Patients With Common Mental Disorders

The goal of this randomized controlled trial is to investigate if online transdiagnostic cognitive behavior therapy (CBT) can be effective in the treatment of common mental disorders in adult primary care patients. The main aim is to investigate: if online transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with a common mental disorder. Researchers will compare online transdiagnostic CBT to primary care as usual to see if psychiatric symptoms can be reduced. Participants will be randomized to online transdiagnostic CBT or primary care as usual. Participants in online transdiagnostic CBT will receive a cognitive behavioral treatment provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform. Participants randomized to care as usual will receive health care services as usual in primary care. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project, but the investigators expect that participants will receive an active treatment.

Durability of the Effects of Low-Intensity Cognitive Behavioural Therapy

This exploratory study investigates the relapse condition in Hong Kong adults after low-intensity cognitive behavioural therapy (LICBT) treatment for 18 to 48 months with a 6-month interval. Individuals who received LICBT treatment between 2017 and 2020 will be recruited to assess their current mental health status. It is hypothesised that the improvements in depression and anxiety scores will be maintained at 18-to-48-month follow-up.