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.

Arts for Wellness (AFW): Arts-Based Social Prescribing During Inpatient Rehabilitation for Older Adults in Singapore

This mixed-methods study examined whether Arts for Wellness (AFW), an artist-led arts programme introduced during inpatient rehabilitation, improves mental wellbeing among older adults in a Singapore community hospital, and explored how and for whom it works. Adults aged 50 years and above admitted to Outram Community Hospital for rehabilitation were randomly assigned (2:1) to AFW plus standard care or to standard care alone. AFW consisted of six group sessions (twice weekly for 3 weeks, 45-60 minutes each) in either dance or literary arts, delivered by trained National Arts Council artists. The art form was determined by which programme was running on the ward during the participant's admission, not by randomisation. After discharge, AFW participants were offered two virtual "Social Hour" sessions, a Take-Home Kit, and linkage to community arts programmes. The main question was whether AFW improves mental wellbeing (Warwick-Edinburgh Mental Well-being Scale, WEMWBS) 4 weeks after baseline compared with standard care. Secondary questions were whether it affects symptoms of depression and anxiety, health-related quality of life, patient satisfaction, and health-care utilisation, and whether any benefit is maintained up to 4 months later. Participants completed questionnaires at baseline, 4 weeks, 12 weeks, and about 20 weeks after baseline. A nested qualitative strand involved interviews with AFW participants and focus groups with artists, health-care professionals, and programme implementers to understand mechanisms, inclusion, and sustainability.

Evaluating Practices That Foster Care Partnerships and Wellbeing Among Informal Carers and Long-term Care Workers

WELL CARE aims to strengthen the supports available to informal carers and long-term care (LTC) workers for improving their resilience and mental wellbeing through care partnerships. The project consortium, lead by prof. Elizabeth Hanson (Linnaeus University) and consisting of six research organizations and nine national and European advocacy organizations, identifies good practices able to prevent or mitigate both occupational and non-occupational risks for informal carers' and LTC workers' resilience and mental wellbeing. On this basis, and under its Grant Agreement with the European Commission, the project team develops innovative solution prototypes, which will be transferable across different countries and contexts and guide stakeholders into the actual implementation in 5 European Union (EU) countries (Germany, Italy, Netherlands, Slovenia, Sweden), where the LTC sector presents dissimilar characteristics. Finally, the investigators will exploit the data and evidence collected and generated by WELL CARE to analyze related EU and national policies, and to formulate action-oriented recommendations for policy makers and stakeholders. The current study protocol concerns the research activities within Work Package 3 of the project, particularly the activities during the Implementation and Evaluation Phase that runs from September 2026 until the end of 2027. During this phase the project team studies the results of local implementation partners' efforts who - building on the solution prototypes developed earlier in the WELL CARE project - develop and implement new supportive work and care practices. The investigators study the effects that implementing these practices brings about among participating caregivers in terms of mental wellbeing, resilience and care partnership dynamics, while also studying the implementation process itself to capture the processes, conditions and (organizational) contexts favorable to fostering care partnerships.

Reducing Problematic Internet Use and Improving Well-Being in Adolescents Through Online Yoga Meditation: A Randomized Controlled Trial

This randomized controlled trial investigated the effects of an online Sahaja Yoga meditation program on problematic internet use, mental well-being, self-esteem, and psychological distress among adolescents and youth in the United States. Participants aged 12-18 years were randomly assigned to either a six-week online meditation intervention or a waitlist control group. The meditation sessions were delivered online by experienced adolescent practitioners of Sahaja Yoga meditation under adult supervision. All participants completed standardized self-report questionnaires before and after the intervention period. The study examined whether participation in the meditation program was associated with improvements in mental well-being and self-esteem, as well as reductions in problematic internet use and psychological distress. A follow-up assessment was also conducted for participants in the intervention group.

The MICROSCOPE Project

This multicenter observational prospective study aims to explore the impact of peri-operative support measures (mentorship or coaching or intraoperative consultation) on the mental well-being of early career surgeons. Furthermore sub-analyses will be conducted to explore the impact that surgeons mental wellbeing related to different support measures could have on patients' outcomes

MDMA-Assisted Therapy for Mental Healthcare Providers

This is a phase 1, open-label study to assess changes in mental well-being following MDMA administration within a therapeutic setting, in mental health providers who are in training to become MDMA assisted therapists. Secondary outcome measures will examine the effects on provider burnout, provider self-efficacy, mood, self-compassion, quality of life, and other psychological factors. Participants will work with a co-therapy pair as they engage in a preparatory session, one experimental session with MDMA, and an integration session the following day.

Preliminary Evaluation of a Mental Health Program: a Comparison Study

The mental hygiene challenge is a Royal Ottawa Health Care Group led initiative to engage the staff, clients and community members to attend to their mental well-being by way of practicing mental hygiene activities for 10 min on a daily basis, throughout the month of March. Participants are encouraged to choose one or many of the practices recommended and do them for about 10 minutes a day. Participants are encouraged to make it their own, in that they can combine the practice or tailor them in a way that suits them best. When signing up for the challenge, participants receive free access to a toolkit with brief outlines and instructional videos on various mental hygiene practices. Study investigators also encourage participants to divide the 10 minutes in whatever way best works for them, such as 10 minutes all at once, 5 minutes twice, or even 2 minutes five times. This study aims to expand on the work that was done in 2022 and 2023, when the World Health Organization - 5 Wellbeing Index (WHO-5) and the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) were collected from participants to ascertain the impact of mental hygiene, by way of including a control group.

Brief Mindfulness Workshop With or Without Virtual Reality: A Pilot Study

The current study uses a randomized cross-over design, in which participants are exposed to brief mindfulness-based experiential sessions with and without incorporating virtual reality (i.e., the experimental and control conditions, respectively). Order of exposure to these two conditions are counter-balanced and participants are randomized into the two arms of exposure in a different order. Furthermore, this study includes the use of both subjective self-report and objective physiological measures of mental wellbeing. It is hypothesized that VR-incorporated mindfulness-based experiential session brings a greater improvement in state mindfulness, state affect, and stress response. Results shed light on the added value of incorporating VR into brief MBIs, particularly in reference to the typical practice of promoting mindfulness in the local community.

RCT: the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students.

Psychological issues are common among university students and affect mental wellbeing. The Caring Universities (CU) project, involving nine Dutch universities, aims to enhance students' mental health through an annual online questionnaire and a platform offering guided eHealth interventions. One intervention, LifeHack, utilizes cognitive behavioral therapy-based modules to improve mental wellbeing by enhancing resilience and life skills. The effects of LifeHack with pre-post measurements (total n = 216 at post-test) found found that LifeHack led to improvements in mental wellbeing, but dropout rates were influenced by lack of motivation and module relevance. A personalized version of LifeHack is being developed to address these issues and will be evaluated in an RCT to assess its effectiveness in improving mental wellbeing and related outcomes among university students.