Clinical Research Directory

SanaMente: A Peer-Led Program to Reduce Health Disparities in Rural Latino/a Communities

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of the SanaMente peer-led mental health and lifestyle program for rural Latino/a adults with chronic medical conditions and mental health concerns. The main questions it aims to answer are: * Is the SanaMente program feasible and acceptable for rural Latino/a adults with chronic medical conditions and mental health concerns? * Does participation in the SanaMente program improve mental health outcomes (depression, anxiety, and stress), healthy lifestyle behaviors (sleep, physical activity, and nutrition), and overall well-being? This is a single-arm pilot study without comparison group. Participants will: * Participate in the 6-8 week SanaMente peer-led group program. * Complete surveys at baseline, mid-program, and post-program assessing mental health, lifestyle behaviors, overall well-being, and program satisfaction. * Complete an exit survey and have the option to participate in a focus group to provide feedback on the program's usability, acceptability, perceived impact, and suggestions for improvement.

Effect of a Programme Including an AI-enhanced Mobile Application on the Mental Well-being of Young Adolescents in Hong Kong - A Cluster RCT Study

The goal of this trial is to evaluate the effectiveness, user perception, and applicability of the e CAMP intervention for improving mental well-being and reducing depressive symptoms among young adolescents. Primary Research Question 1. Does the e-CAMP intervention significantly reduce depressive symptoms among students, as measured by the Patient Health Questionnaire-9 (PHQ-9)? Secondary Research Questions 2. To what extent does the e-CAMP intervention enhance mental health knowledge and literacy among adolescents, as assessed by the Chinese-version Universal Mental Health Literacy Scale for Adolescents (UMHL)? 3. How does participation in the e-CAMP intervention impact students' smart device usage behaviors, as measured by the Smartphone Addiction Scale (SAS)? 4. Does the e-CAMP intervention effectively reduce sedentary behavior and increase total physical activity, as measured by the Global Adolescent and Child Physical Activity Questionnaire (GAC-PAQ) and smartwatch data? 5. How do participants and teachers perceive the applicability, acceptability, and sustainability of the e-CAMP intervention, based on survey and in-depth interview feedback guided by the RE-AIM framework? Method : A prospective cluster RCT with two arms according to the cluster CONSORT 2010 checklist and guide \[23\] will be conducted. Eight eligible schools will be assigned randomly to the intervention or usual care group. The process evaluation will be guided by the RE-AIM framework \[19-20\]. Convenience sampling will be used to recruit eligible students ( about 320 ) from eight primary or secondary schools in Hong Kong. All schools are under Education Bureau of Hong Kong. The inclusion criteria will be students at participating schools who can read Chinese and are aged 11-15 (P5 to F2), with parental consent. Students with known physical (musculoskeletal) or cognitive/mental problems that would compromise physical exercise or our intervention or outcomes will be excluded. experimental group ( e-CAMP mobile app group) : In addition to receiving the usual school care, participants in intervention schools will be provided with a QR code and installation guide and instructed to install the e-CAMP mobile app. Participants will be encouraged to use the e-CAMP app at least thrice weekly during the first 8 weeks of the intervention. Each usage session is expected to last approximately 10-15 minutes. Control group : Participants in control schools will receive usual school care, a 45-minute health talk delivered by a nurse. A PowerPoint handout will be provided to all participants after the health talk.

Social Prescribing for a Mindful Lifestyle

The goal of this clinical trial is to evaluate the effectiveness of an 8-week mindfulness lifestyle social prescribing program in community-dwelling older adults aged 55 and older. The main questions it aims to answer are: To establish a mindfulness lifestyle social prescribing model applied to the psychological and social health promotion of middle-aged and older populations. To evaluate the effectiveness of the intervention on improving depressive symptoms, loneliness, and quality of life in this population. Participants will receive an 8-week group intervention program, with each weekly session lasting approximately 3 hours. The structured curriculum integrates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (such as herbal therapy and leaf printing). Researchers will collect and evaluate data from pre- and post-intervention assessments to measure changes in depressive symptoms, loneliness risk, and overall quality of life.

Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore

Cognitive-behavioural therapy (CBT) has a robust evidence base for treating anxiety disorders and depression, including transdiagnostic CBT. Internet-based CBT (iCBT) offers a new approach to delivering these therapies. iCBT is a digital adaptation of traditional CBT that leverages digital platforms to deliver similar therapeutic interventions. iCBT encompasses structured programmes that provide users with tools and techniques to manage mental health issues such as depression and anxiety. The digital format ensures timely access to CBT and typically includes interactive modules, videos, self-assessment tools, and virtual therapist support. This study aims to evaluate the effectiveness of iCBT in reducing symptoms of anxiety and depression, as well as its cost-effectiveness and acceptability in local context. The main questions it aims to answer are: 1. Do participants receiving iCBT show a reduction in symptoms of anxiety and/or depression, and does the effectiveness of iCBT vary based on individual user characteristics? 2. What are the factors that influence the acceptance, adoption, and engagement rates of iCBT among Singaporeans? 3. Is iCBT more cost-effective as compared to usual care? Researchers will compare guided iCBT to usual care (traditional CBT) to assess iCBT's clinical effectiveness, cost-effectiveness, and acceptability in Singapore's primary and community healthcare settings. Participants in the intervention group will: 1. Undergo guided iCBT intervention consisting of 8 weeks of online modules covering core CBT techniques 2. Counsellors will schedule 3 regular check-ins 3. Questionnaires will be administered at 5 timepoints 4. Selected participants will be invited for a semi-structured interview to assess their experiences with iCBT Participants in the control group will: 1. Continue usual care 2. Questionnaires will be administered at 5 timepoints A parallel qualitative study involving service providers is required to contextualise trial findings, identify implementation barriers and enablers and inform national scale-up and policy decisions. It aims to explore service providers' experiences, perceptions and contextual factors influencing the implementation of iCBT within routine primary-care and community mental-health services participating in this trial.

Testing Adapted Self-Help Plus (SH+) for Stress and Well-Being in International Students at a U.S. University

The goal of this clinical trial is to learn if an adapted version of Self-Help Plus (SH+), a stress management program developed by the World Health Organization, can reduce stress and improve well-being in international students at a U.S. university. The main questions it aims to answer are: Does SH+ reduce perceived stress, anxiety, and depressive symptoms in international students? Does SH+ improve feelings of social support, self-efficacy, and adjustment in a new cultural environment? Participants will: Attend a two-day in-person workshop that includes animated videos, interactive activities, and group discussions. Complete three surveys (before the workshop, right after, and six weeks later) about stress, mood, and well-being. Optionally, take part in a short interview to share feedback about their experience.