Clinical Research Directory

Randomized Controlled Trial on Precision Mental Health

The current study aims to evaluate the effectiveness of different online psychological interventions, including guided and unguided transdiagnostic cognitive behavioural therapy, and unguided mindfulness-based intervention, on mental well-being in comparison to waitlist control. It is hypothesized that participants with the guided psychological intervention will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants with unguided psychological intervention and the control condition.

Study of Self-Help and Support Services for Student Mental Health in Tertiary Institutions

This proposed study aims to evaluate the implementation of integrating the existing services in tertiary education institutions with the JCTH+ platform. The study aims to evaluate the efficacy of JCTH+ on students' mental health outcomes as compared to service as usual, and to assess the cost-utility of the platform to determine whether the benefits of implementing the platform justify the costs associated. It is hypothesized that participants who receive integrated self-help and support services will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants in the control condition, i.e. service-as-usual (SAU).

Active Families, Healthy Minds: A Family-Centered School Physical Activity Program for Early Adolescents

This study evaluates the effectiveness of a family-centered school physical activity program, titled "Active Families, Healthy Minds," designed to improve mental health among early adolescents (ages 10-14) in China. In response to high academic pressure and low physical activity levels, this program integrates structured physical education sessions at school with simple, interactive home-based activity routines involving parents. The study compares this family-supported intervention against a standard school-only physical activity program and a wait-list control group. The primary goal is to determine if involving parents in school-based physical activity initiatives leads to better mental well-being, increased habitual physical activity, and stronger family support compared to school-only approaches.

Impact of Mental Health First Aid-trained Peers on the Mental Well-being of First-year Medical Residents.

Medical students, especially those in postgraduate training, face a complex array of challenges such as fatigue; work-life balance conflicts; difficulties managing dual hierarchies (hospital and university). Surprisingly, residents receive little to no dedicated training in recognizing and managing psychiatric disorders, except for psychiatry residents. This gap is exacerbated by persistent stigma towards psychiatric conditions. The Mental Health First Aid (MHFA) training approach could offer an innovative solution, addressing the root of the problem. This prospective, single-center cohort study aims to compare (1) the mental well-being of first-year specialty residents in the Lyon subdivision exposed to MHFA-trained peers; with (2) the mental well-being of unexposed second-year specialty residents. The hypothesis is that exposure to peers trained in MHFA improves well-being and reduces symptoms of burnout, depression, and anxiety at 3, 6, 9, and 12 months among peer residents.

The Effect of Heat Application and Abdominal Massage on the Gastrointestinal System and Mental Well-being of Patients With Hip Fractures

This randomised controlled trial was designed to determine the effect of early-stage heat application and abdominal massage on patients' gastrointestinal function and mental well-being following hip fracture surgery. The study's hypotheses are as follows: H0: Heat application and abdominal massage administered in the early postoperative period have no effect on gastrointestinal function or mental well-being. H1: Heat application in the early postoperative period affects gastrointestinal function and mental well-being. H2: Abdominal massage administered in the early postoperative period has an effect on gastrointestinal function and mental well-being. The Patient Information Form, Gastrointestinal Symptom Rating Scale (GSRS) and Warwick-Edinburgh Mental Well-being Scale will be administered. Starting from the morning of the first day after surgery, patients will receive abdominal massage and heat application twice daily, in the morning and evening, for three days. The warm compress and abdominal massage will be performed consecutively. The total application time will be 30 minutes, consisting of 15 minutes of warm compress and 15 minutes of abdominal massage. Abdominal massage will be performed on patients in the experimental group using the 'abdominal massage application guidelines'. Abdominal massage involves techniques such as effleurage (stroking and spreading), petrissage (kneading) and vibration. After each application of massage, the patient's bowel sounds and movements will be listened to using a stethoscope. Before applying heat and performing the abdominal massage, care will be taken to ensure that the patient does not need to urinate, and that the room is quiet and at a suitable temperature. Patients in the experimental group will not be given laxatives, suppositories or enemas for three days; only heat application and massage will be performed during this period. During this period, researchers will assess the defecation of patients using the Bristol Stool Scale. At the end of the three-day follow-up period, patients will be asked to complete the Bristol Stool Scale, the Gastrointestinal Symptom Rating Scale and the Warwick-Edinburgh Mental Well-being Scale.

Youth-for-Youth Mental Wellness Care and Action

This initiative aims to improve flourishing and quality of life of secondary school students, reduce mental distress (e.g., depression and suicidal ideation), enhance their understanding of mental health (e.g., mental health literacy) and help-seeking intention, and foster a supportive school environment (e.g., school climate-caring relationship, and sense of community). Also, this initiative aims to improve students' process of change in psychological (e.g., mattering, emotion regulation, empowerment) and social (e.g., trust belief) aspects and mental health awareness (e.g., mental health stigma). The feasibility, acceptability, and sustainability of the programme from multiple perspectives (e.g., students, student leaders, and stakeholders) will also be evaluated. In addition, the cost-effectiveness of delivering this programme (e.g., the incremental cost-effectiveness ratio (ICER)) among secondary schools in Hong Kong will be assessed. The programme will be implemented among students in 130 local secondary schools over three academic years. The first is a pilot phase (Year 1), which 40 schools will implement the intervention and student participants will be evaluated at pre- (T0) and post-intervention (T1) using questionnaires. In this stage, participatory research will be conducted before and after the intervention among students, student leaders, and stakeholders in 20 pilot schools to co-design the intervention, ensuring the programme meet the actual wellness needs of youth. In following two academic years, an additional 90 schools will participate in a cluster randomized controlled trial (RCT) with a 1:1 ratio between intervention and waitlist control groups. Each year, 45 schools will implement the intervention. Summative evaluation will be conducted among RCT schools at T0 and T1, and 3-month follow-up (T2). Quantitative data be collected to assess the effectiveness of intervention, and qualitative data will provide understanding of students' and stakeholders' perspectives of the intervention implementation. Cost outcomes will include intervention costs and cost savings, calculated from the payer (i.e., JC/government) perspective using administrative records or validated tools. The primary outcome of effectiveness will be the quality-adjusted life-years (QALYs) of students. Cost and QALYs will be used to evaluate the cost-effectiveness of the intervention, for example, estimate the incremental cost-effectiveness ratio (ICER).

Evaluation of the School-based SIM Program in Upper Secondary School Students

Söderqvist et al. recently reported on a new school-based program designed to promote mental well-being in adolescents: the Solution-Focused Intervention for Mental Health (SIM, https://doi.org/10.1016/j.ssmmh.2025.100493). While previous studies on SIM were designed mainly to test, develop, refine and improve the program and its feasibility in a school setting, the current project aims to test the efficacy of SIM on adolescent mental health, primarily mental well-being. A two-arm, cluster, randomized, controlled trial will be conducted. The intervention group will receive the SIM program, and the control group will receive a lecture on mental well-being along with the usual school provisions. Randomization is done by class because the intervention takes place in mentor groups. Based on the results of our largest feasibility study, 559 students are required for paired measurements to detect a small effect on mental well-being with 80% power and a significance level of 0.05. The evaluation is based on validated instruments, with measurements taken before and after the intervention, as well as six and nine months later. The project is being implemented in collaboration with six upper secondary schools in Sweden. Recruitment and anchoring at the participating schools, as well as class randomization strafied on educational program, took place in 2025. Enrollment of participating students will begin in January 2026. This project will contribute new knowledge to the field by evaluating a universal program for schools to use in their health promotion work. The latter is important since high levels of mental well-being independently predict a lower incidence of subsequent mental illness and have a range of positive effects on individuals and society.

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.

Emotional Freedom Techniques and Virtual Reality Application for Fear of Childbirth

Fear of labour in primiparous pregnant women is an important factor that directly affects the mother-infant relationship and the mental health of the mother. In this process, it is common for expectant mothers to experience feelings of uncertainty and anxiety about labour. Such intense fear of birth may weaken maternal attachment and make it difficult for her to establish a healthy emotional relationship with her baby. In addition, this fear may negatively affect the mother's mental well-being and increase the risk of depression and anxiety. In this context, emotional liberation techniques (EFT) and virtual reality (VR) applications stand out as effective nonpharmacological methods used to reduce fear of childbirth in primiparous pregnant women. EFT is a technique that provides relaxation by touching the energy meridians that help the person to regulate negative emotions and cope with stress. SG, on the other hand, allows expectant mothers to interact with simulations similar to the real world in a virtual environment, providing therapeutic benefits through distraction, stress reduction and cognitive restructuring, allowing them to manage their fears about birth and enter the process more prepared. The use of SLT and SG, especially for primiparous pregnant women, can alleviate these women's anxiety about childbirth and enable them to approach the process in a safer and more conscious manner. Thus, it may also help to reduce the negative effects on the mother's postnatal attachment and mental health. This study aims to examine the effects of SLT and SG practices on fear of childbirth, attachment and mental well-being, and to reveal the effects of these two methods on primiparous pregnant women. In this context, this study will fill the gap in the literature by providing a new perspective in clinical practice and antenatal education programmes and will make important contributions to increase antenatal attachment and mental well-being in primiparous pregnancy.

Youth Promotion of Resilience Involving Mental E-health

There is a critical gap in access to mental health promotion, prevention and support among youth worldwide, especially in low and middle-income countries like Vietnam. The Y-PRIME Study aims to respond to this gap by co-designing with Vietnamese youth a mobile app that delivers life skills and self-management skills intervention to promote mental well-being in grade 10 Vietnamese students. Working with the Vietnam Youth Advisory Council (V-YAC) to adapt and co-design the intervention and app ensure that the intervention will be culturally appropriate and relevant to Vietnamese youth. The goal of the current phase is to test this intervention with grade 10 students across three provinces (Hanoi, Thai Binh, and Hung Yen) to assess: 1. Whether the app helps to improve mental well-being and resilience among youth in Vietnam and helps to reduce factors that might increase the risk of poor mental well-being, like stress related to school and other pressures 2. Whether the app can be delivered in Vietnamese schools 3. Whether Vietnamese youth and school staff think the app is appropriate and appealing for youth in order to scale-up the model across the country The control group (meaning they do not have access to the app-based intervention) will complete the outcome survey at baseline, 6 months, and 12 months. After 12 months, they will gain access to the intervention app (at the same time as the experimental group) but no more data will be collected. The intervention group will use the app at their own pace for 1 year while completing the same survey at baseline, 6 months, and 12 months marks. Afterwards, students and school health staff will be invited to a focus group discussion to talk about their experience using the app.

PPI and Mindfulness App for Parents of Children with a NDD

An app based on positive psychology and mindfulness to support the mental well-being of parents of children with a Neurodevelopmental Disorder (NDD) was developed and will be evaluated on effectiveness.

Fitness Buddy Program to Boost Physical Activity in University Students

This study explores whether a peer-supported "fitness buddy" program can help first-year university students increase physical activity levels and improve mental well-being. Over 12 weeks, participants will form small exercise groups, choose enjoyable activities (such as jogging, cycling, or yoga), and support each other through shared goals and regular check-ins. A professional coach will offer weekly guidance on exercise safety, injury prevention, and motivation strategies, but the actual workouts will be conducted by the students. The investigators aim to determine if this peer-based approach helps reduce stress, anxiety, and depressive symptoms, while boosting self-esteem and social connectedness. Students in a control group will receive usual campus resources without structured group support. By comparing outcomes at the start, after the 12-week program, and again at follow-up, the study will assess whether peer-led, knowledge-supported exercise can sustainably enhance both physical and mental health during the critical transition into university life.

Long-term Academic and Psychosocial Impact of Child's Sleep: Parental Influences

The proposed longitudinal project aims to understand parental influences on children's sleep and will investigate the effect of sleep-related parental factors - (1) parents' value of their children's sleep relative to other activities, (2) parental involvement in setting children's sleep habits and enforcing good sleep hygiene, and (3) parent's own sleep habits - on school-age children's sleep, mental health, socio-emotional resilience, and academic/cognitive performance. It will also investigate the impact of social economic status on these sleep -related parental factors.

From the Heart: Comparing the Effects of Spiritual and Secular Meditation on Psychophysiology, Cognition, Mental Health, and Social Functioning in Healthy Adults

The purpose of this study is to investigate and compare the effects of Christian and Islamic heart-centred spiritual meditation to mindfulness meditation and waitlist control conditions, respectively, in healthy adults. The potential effects will be studied at multiple levels, with a focus on psychophysiology, cognition, mental health, and social functioning.

Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)

The Alpha Omega Cohort is a prospective study of 4,837 state-of-the-art drug-treated Dutch patients aged 60-80 years who had a clinically diagnosed myocardial infarction up to 10 years before enrolment. During the first 40 months of follow-up, patients took part in an experimental study of low doses n-3 fatty acids (Alpha Omega Trial, ClinicalTrials.gov NCT00127452). At baseline (2002-2006), data on medical history, medication use, diet, lifestyle and other factors were collected by means of questionnaires. Patients were physically examined by trained research nurses and blood samples were obtained. Follow-up for vital status and cause-specific mortality is ongoing. The trial was approved by a central medical ethics committee (Haga Hospital, The Hague, The Netherlands) and all patients provided written informed consent.