Clinical Research Directory

PERMA-Based Mobile Psychological Intervention With and Without Telephone Support for University Students

University students face increasing academic and psychosocial demands that place them at risk of reduced psychological well-being. Positive psychology interventions have demonstrated efficacy in promoting mental health; however, few are grounded explicitly in Seligman's PERMA model and adherence to digital interventions remains limited. This randomized controlled trial aims to evaluate the efficacy of a brief PERMA-based psychological intervention delivered via a smartphone application, with and without supplementary telephone multiconference support, compared to a waiting list control group. The intervention consists of five weekly modules targeting Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment. Assessments will be conducted at baseline, post-intervention, and at six-month follow-up.

Meet Me on the Pitch: Developing and Testing a Community-Based Sports and Behavioral Health Intervention for Youth

This study evaluates Meet Me on the Pitch (MMotP), a community-based intervention that integrates sports, schools, and behavioral health with the goal of improving the behavioral health, well-being and academic performance of youth. MMotP is a novel approach that builds on evidence-based practices by using sports as a means to foster social-emotional development and address barriers to academic, health, and social services. The study assesses feasibility, acceptability, and short-term outcomes through a randomized controlled trial comparing MMotP to standard sports programming. The intervention will be implemented by the non-profit organization Soccer Without Borders and evaluated by the University of California, San Francisco.

Test-Retest Reliability of the WB6Dim Digital Well-Being Tool: A 3-Day Interval Study

This study aims to establish the test-retest reliability of the WB6Dim digital self-assessment tool across its eight well-being dimensions, using a 3-day interval protocol designed to minimize the probability of genuine well-being changes between assessments. Participants complete the 28-item WB6Dim questionnaire at baseline (T1) and again 3 days later (T2). A single contamination control question at T2 identifies participants who experienced a significant life event during the interval; these pairs are excluded from primary ICC analyses and retained for exploratory analyses. An optional third assessment at 9 weeks (T3) provides preliminary exploratory data on sensitivity to change following access to a well-being program. T3 is not part of the primary design.

Development of the Online Mindfulness-based Intervention (Mind Space Application) for Thai-university Students: Phase II

Development of the online mindfulness-based intervention (MFU-mindful Application for Thai university students: Phase II Objectives: Phase I: (October 2025 to September 2026) 1. To develop the mindfulness-based intervention (Mind Space application) for Thai university students. 2. To test the feasibility of the mindfulness-based intervention (Mind space Application) for Thai university students. 3. To determine the effect size of mindfulness-based intervention (Mind space Application) on mental health outcomes for Thai university students: A pilot study. Phase II: (October 2026 to December 2026) 1\. To examine the effects of mindfulness-base intervention (Mindspace Application) on mental health outcomes for Thai university students For this research project, investigators will develop the mindfulness-based intervention (Mindspace application) based on mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) by encouraging participants to pay attention to their present thoughts, emotions, feelings, and behaviors without judgment. This attention will help them learn the relationship between their thoughts, emotions, and behaviors and their mental health outcomes (mindfulness, stress, anxiety, and depression), though. mindfulness practice (body scan, sitting meditation, and mindful movement) using an online application). Furthermore, investigators will teach participants how to shape their thoughts and manage their wandering minds and negative and irritable thoughts. Finally, participants will learn how to become an individual with reasonable flexibility and positive thoughts. Settings: the researchers plan to conduct the program in three universities in Northern Thailand. Population and sample: Population: Thai university students who are between years 1 and 4 (undergraduate). Sample: Phase I: Mae Fah Luang University, Phayao University, and Utraradit University students who are studying during the Fall semester, year 2026. Investigators will specifically recruit volunteers who: Inclusion criteria: 1. are current studying in years 1-4 of undergraduate programs 2. can read, speak, and write in Thai 3. be risk of the mental health problem (score higher than 6 on the General Health Questionnaire (GHQ-28) 4. have no history of learning disorders (ADHD, other specific learning disorders) 5. have no psychiatric disorders (schizophrenia, adjustment disorders, delusion disorders, and substance use disorders) 6. have no meditation experience within the past 6 months Exclusion criteria: 1. have a limitation for mindful movement (hearing loss, blindness, and movement limitations) 2. They may feel uncomfortable or distressed and may not be able to participate in each mindfulness-based intervention session. Conceptual frameworks. For this research project, the investigators will develop and refine an online mindfulness-based intervention, the Mind Space Application, grounded in the principles of Mindfulness-Based Stress Reduction (MBSR; Kabat-Zinn, 2003) and Mindfulness-Based Cognitive Therapy (MBCT; Segal et al., 2002). The program is designed to cultivate nonjudgmental awareness of thoughts, feelings, emotions, and behaviors among university students (Kabat-Zinn, 2003). In addition, it aims to enhance participants' understanding of the interrelationships among cognitions, emotions, affective experiences, and behaviors that contribute to psychological distress, including stress, anxiety, and depressive symptoms. The intervention incorporates core mindfulness practices delivered via an online application, including body scan exercises, sitting meditation, and mindfulness-based movement for relaxation. Furthermore, participants will be guided to develop cognitive awareness and adaptive responses to internal and external stressors, with particular emphasis on recognizing and managing automatic thoughts (wandering mind), negative thoughts, and irrational or maladaptive cognitions. Through this process, participants are encouraged to cultivate more rational, flexible, and positive thinking patterns. The researchers anticipate that this program will enhance mindfulness skills and, in turn, contribute to reductions in stress, anxiety, and depressive symptoms among the study participants. The effectiveness of the Mind Space application will be examined across both short-term and long-term periods. Short-term effects will be assessed at baseline and immediately post-intervention (8 weeks), while long-term effectiveness will be evaluated at a 6-month follow-up. Outcomes in the intervention group will be compared with those in a control group. The primary outcome variables include mental health indicators-stress, anxiety, and depressive symptoms-as well as levels of mindfulness among Thai university students. Data will be analyzed using a one-way repeated-measures multivariate analysis of variance (MANOVA).

A Robot-assisted Tailored Activity Programme for People With Dementia and Their Caregivers

To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads.

Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants

The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a culturally adapted internet-based cognitive behavioral therapy (i-CBT) intervention in reducing symptoms of common mental health issues among Farsi/Dari-speaking youth migrants and refugees. Investigator hypothesizes that there will be a significant decrease in psychological symptoms after participants receive the intervention compared to a control group.

The Effects of Nature-Based Activity vs. Indoor Exercise on Cognition, Psychological, and Physiological Health

This randomized controlled trial aims to investigate the comparative effects of nature-based versus indoor exercise interventions on cognitive performance, psychological well-being, and physiological stress in Malaysian adults. Participants will be randomly assigned to one of four groups: (1) active nature engagement (walking outdoors), (2) passive nature engagement (seated outdoor observation), (3) indoor treadmill walking, or (4) a no-intervention control group. The study will examine changes in attention, working memory, affect, blood pressure, body composition, and salivary cortisol across baseline, mid-point, and post-intervention assessments.

Interventions to Promote Well-being and Social Relationships Among University Students

This study evaluates the impact of a psychological group intervention aimed at promoting well-being and social connectedness among university students. The intervention is part of the UNIST-HEALTH (PRO-BEN) initiative and targets students enrolled at the University of Padua. Participants will be randomly assigned to either an intervention group or a waitlist control group. The intervention consists of six weekly group sessions focused on psychoeducation and experiential activities designed to enhance the quality of social relationships, reduce loneliness, and improve psychological well-being. Assessments will be conducted at baseline, post-intervention, and at a four-week follow-up.

Va Meh Du: A Sports-based Mental Health Promotion Intervention for Karenni Refugees

The goal of this clinical trial is to learn if a soccer program focused on mental health positively impacts mental health in Karenni refugee young boys and men. The main questions it aims to answer are: Does mental health education provided during a sports program improve mental health coping for Karenni refugee young boys and men? Does participation in a sports-program improve social connection for Karenni refugee young boys and men? Researchers will compare those receiving mental health education to a comparison group to see if mental health education improves mental health coping skills. Participants will: Participate weekly soccer practices for 6 months Receive mental health education or comparison activities Answer questions about their health, such as their coping skills, social connection, and physical activity

ENERGY2MOB STUDY: OBESITY MANAGEMENT IN BERGUEDÀ

Background: Obesity is a prevalent multifactorial disease worldwide and has become a significant public health concern. The latest data from the 2022 Catalonia Health Survey show that 56.2% of men and 43.7% of women are overweight or obese, and 39% of children aged 6 to 12 years have excess weight. Excess adiposity poses a health risk as it is associated with various chronic diseases such as type 2 diabetes mellitus, hypertension, and dyslipidaemia, all of which affect quality of life and increase mortality risk. Hypothesis: The Energy2MOB obesity management programme in Berguedà is a group-based intervention incorporating nutrition education and physical activity. It aims to reduce excess body weight and the risk of chronic diseases, including type 2 diabetes mellitus, dyslipidaemia, and hypertension, through a multicomponent approach that enhances dietary habits, physical activity, and emotional eating regulation. Objectives * Assess the effectiveness of the Energy2MOB programme in reducing body weight by 5-10% among adults with obesity in the Berguedà health region. * Measure lifestyle modifications, including dietary habits, physical activity, and emotional eating. Methodology: A randomised clinical trial with two groups (control and intervention) over one year, including individuals aged 18-65 years in the Berguedà health region with overweight grade II (BMI 27-30 kg/m²) or obesity (BMI 30-40 kg/m²). Exclusion criteria include significant language barriers, previous bariatric surgery, moderate to severe cognitive impairment, and severe psychiatric disorders preventing participation in sessions. Participants must attend at least 80% of the programme. Measurements * Sociodemographic factors: sex, age, education level, marital status, employment status. * Lifestyle factors: alcohol and tobacco use, dietary habits, physical activity, emotional eating, health-related quality of life. * Anthropometric parameters: body weight, height, BMI, waist circumference. * Blood pressure, medication use, biochemical parameters (fasting glucose, glycated haemoglobin, lipid profile, liver and kidney function markers, C-reactive protein). Statistical Analysis: Accepting an alpha risk of 0.05 and a statistical power above 0.8 in a bilateral contrast, 68 subjects per group are required to detect a difference of at least 2.5 kg. A common standard deviation of 4.77 is assumed, with an estimated 15% dropout rate. Sample size calculations were performed using GRANMO version 8.0 (https://www.datarus.eu/ca/aplications/granmo/; consulted in November 2024). Expected Outcomes, Applicability, and Relevance: This study aims to generate scientific evidence on the effectiveness of multicomponent group-based interventions focused on improving nutrition, physical activity, and psychological well-being in obesity and chronic disease management. It seeks to create an environment that facilitates behavioural changes, leading to weight reduction and improved quality of life. The findings will also contribute to the development of a practical guide for addressing excess weight in primary healthcare settings. Keywords (maximum 6): Adult obesity, primary health care, group interventions, dietary interventions, multicomponent interventions, Mediterranean diet.

Survey of Psychological Well-being of Health Care Workers in the Hospital Setting

The psychological well-being of healthcare workers in hospital settings is a topic of growing interest in the scientific literature, given the crucial importance of their role in ensuring high-quality care. In addition, the Covid-19 pandemic health emergency has further accentuated the relevance of this issue, increasing anxiety and stress levels, testing the resilience and resistance of those working in care settings, revealing and highlighting how the accumulation of work-related stress can result in disabling pathologies for the caregiver, with an inevitable impact on the facility and care in general. Recent studies show that health care workers are particularly vulnerable to work-related stress, which can result from various factors such as high work demands, emotional pressure, irregular shifts, and interactions with critically ill patients. Burnout syndrome, characterized by emotional exhaustion, depersonalization and reduced personal accomplishment, is widely documented among hospital staff. Research indicates that burnout not only compromises the psychological health of healthcare workers, but also negatively affects the quality of care provided by increasing the risk of medical errors. In light of these factors, it is crucial to deepen our understanding of the dynamics that influence psychological well-being and work-related stress in health care workers in order to develop effective interventions that can improve their quality of life and consequently the quality of care provided to patients. Preliminary assessment of the emotional burden and motivational aspects of health care workers (showing what very often eludes a first glance, making visible something that is often invisible), along with effective stress management, would allow for greater ability to remain calm under pressure, reduced frustration, increased ability to make informed decisions, and to communicate effectively with patients and colleagues. These aspects translate into an image of a safer and more caring health care system in promoting better quality of care. The aim of this project is to highlight the importance of psychological wellbeing for those working in health care settings and to promote attention to this area, also with a view to identifying possible interventions aimed at identifying preventive and protective factors in relation to health care workers. The aim, therefore, is to show what is very often invisible at first sight, to make visible what is invisible: to explore, accommodate and contain areas of criticality and fragility in the context of work in health care settings, working on interventions aimed at the psychological well-being of workers.

Biopsychosocial Effects of Gardening Activities

Due to the increasing number of elderly population worldwide, elderly care is becoming increasingly important and the number of elderly in institutional care is increasing. In this context, the implementation of easily applicable, cost-effective and accessible physical activity programmes for the elderly in nursing homes is important for the physical, mental and social health of the elderly. Gardening activities are a non-pharmacological intervention that has recently increased in popularity in the elderly and can be easily applied. It is known that gardening activities in the elderly affect some biochemical parameters along with mental health effects and reduce stress, especially by reducing cortisol levels. By providing physical mobility in the elderly with gardening activities, there may be an increase in irisin level and BDNF level, which is an indicator of improvement in cognitive functions, and a decrease in cortisol level, which is an indicator of stress. With the project, the effects of gardening activities on the elderly will be examined comprehensively in a biopsychosocial manner. In this project, the effects of gardening activities on anxiety, depression, life satisfaction, psychological well-being and biochemical parameters will be examined in the elderly living in a nursing home. In the project, gardening activities will be applied to the elderly in the experimental group once a week for 60 minutes for 16 weeks (4 months). With the project, it is aimed to strengthen the elderly biopsychosocially by making them do gardening activities.