Clinical Research Directory

Heart Rate Variability Biofeedback in Security Forces

This exploratory study evaluates the effectiveness of a 12-session Heart Rate Variability Biofeedback (HRV-BFB) protocol in reducing distress and burnout while promoting psychological well-being among Portuguese National Republican Guard (GNR) professionals. Exposed to high occupational stress from unpredictable risks, shift work, and limited resources, these individuals face elevated vulnerability to chronic stress outcomes. The intervention leverages real-time HRV feedback to enhance autonomic regulation, breathing techniques, and emotional self-regulation.

Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia

This is an assessor-blinded, randomized, MAS-controlled trial. A total of 148 adolescents aged 15-22 years experiencing mild to moderate anxiety or depressive symptoms will be recruited. They will be randomly assigned to DCEAS+BA (n = 74) and MAS (n = 74) for 2 sessions per week for 8 weeks, followed by a 4-week post-treatment observation period. A post-intervention visit will be held at week 12. The primary outcome will be assessed using the Chinese version of the Beck Anxiety Inventory (BAI-C). The secondary outcomes include the Beck Depression Inventory II (C-BDI-II) for depression, the Zung Self-Rating Anxiety Scale (SAS) and the Zung Self-Rating Depression Scale (SDS) as additional assessments for anxiety and depression, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, and the World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) for the general quality of life. Assessment will be carried out every 4 weeks till week 12, while saliva will be collected at baseline and at the end of the 8 weeks. Salivary oxytocin and cortisol will be analyzed. A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the two groups and linear regression will be conducted to examine intercorrelations among clinical improvement and changes in biomarker levels. Subgroup analysis will be conducted to identify specific effects of DCEAS+BA.

Group Psychological Intervention to Reduce Distress Among Nursing Undergraduates

This is a randomized controlled trial. The study aims to explore the effect of group psychological intervention on academic distress among nursing undergraduates whose score on the self-developed Nursing Undergraduate Academic Distress Scale is ≥29. Eligible students will be randomly assigned to the intervention group or the control group. The intervention group will receive an 8-week structured group psychological intervention, while the control group will receive routine mental health education. The primary outcome is the change in academic distress score from baseline to the end of the 8-week intervention. Feasibility of the intervention program will also be evaluated.

Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT

This is a two-arm, stratified cluster-randomized controlled pilot trial evaluating the feasibility and preliminary effectiveness of the World Health Organization's Self-Help Plus (SH+) intervention for stress reduction among social service workers employed by the Istanbul Provincial Directorate of Family and Social Services (ASHP). Four institutions (clusters) are randomized 1:1, stratified by service type, to receive either SH+ plus Enhanced Care as Usual (ECAU) or ECAU only, with a target of 50 participants (25 per arm). The primary aim is to assess feasibility indicators (recruitment, session attendance, retention, and acceptability) to inform a future full-scale definitive trial. Preliminary effects on perceived stress and related mental health and well-being outcomes are examined as secondary outcomes.

Homeless Lifestyle Community Survey

This survey will help investigators learn everything about how people view and respond to trauma, and if nutrition, body-mind-spirit, or holistic practices will be effective in helping people recover from these types of lifestyles. The responses will be used to shape the integrative protocols that the investigators develop for professionals involved with trauma clients. This can help increase recovery rates and lead to productive lives.

Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.

Diabetes-related distress is a psychological construct associated with poorer glycaemic control in people living with diabetes. In France, few data are available on this topic and none focus specifically on adults with type 2 diabetes. Diabetes-related distress is not mentioned in the current French national guidelines on the management of type 2 diabetes, whereas international societies such as the ADA and, more recently, the EASD now recommend its regular assessment. This single-centre observational study conducted in the endocrinology department of Nice University Hospital aims to estimate the prevalence of severe diabetes-related distress in adults with type 2 diabetes receiving usual care, and to identify associated clinical, psychosocial and lifestyle factors. Participants complete validated self-report questionnaires (PAID-20 for diabetes distress, WHOQOL-BREF for quality of life, and a modified Starting The Conversation dietary questionnaire), and clinical data are extracted from electronic medical records. The study does not modify usual medical management and participation consists only in completing the questionnaires and receiving feedback on the results.

Testing a Non-Deceptive Placebo Intervention for Subclinical Depressive Symptoms

Subclinical depression - depressive symptoms that fall below the threshold for major depressive disorder - is common in young adults and predicts later depressive episodes, yet it often goes untreated. This study tests whether a brief, remotely delivered non-deceptive (open-label) placebo intervention reduces subclinical depressive symptoms over approximately two weeks. Participants aged 18-30 living in Ohio, with PHQ-8 scores in the 5-9 range, are randomly assigned to one of three groups: a non-deceptive placebo group, a blinded control group, or an unblinded control group. All participants complete three remote sessions over 16-18 days and complete the same assessments on the same schedule. Participants in the non-deceptive placebo group additionally receive psychoeducation about placebo effects and placebo pills that are explicitly described as containing no active ingredients, which they take twice daily for two weeks. Participants in the unblinded control group are told they have been assigned to a control condition. Participants in the blinded control group are not told their group assignment until debriefing at the end of the study. The study has two aims. The first is to estimate the effect of the non-deceptive placebo intervention on depressive symptoms and related outcomes. The second is methodological: to determine whether telling control participants that they are in a control group changes their outcomes, and therefore whether the choice of control condition systematically biases estimates of non-deceptive placebo effects.

A Community-based, Peer-led Counseling Service: A Hybrid Type 3 Effectiveness-implementation Study

The goal of this observational study is to learn how a community-based peer counselling service works in everyday practice and whether it helps people who are going through a psychologically difficult time. Peer counsellors are trained people with their own lived experience of mental health problems. The service, Peerberatung St. Gallen, already exists in St. Gallen, Switzerland. It offers up to six one-hour counselling sessions per year per client. The study does not change the service or decide who receives it. The main questions this study aims to answer are: * Do clients report changes in their personal recovery, well-being and stress after using the service? * How do clients experience the counseling, and what do they find helpful? * How is the service put into practice, and how do peer counsellors and partner organizations view it? Clients who use the service will: * Fill out an anonymous questionnaire at the start of counseling and again after their last session * Be invited to take part in an interview about their experience Peer counsellors and staff of partner organizations will: \- Fill out a questionnaire about how acceptable, appropriate and practical they find the service Be invited to take part in group discussions (peers) or interviews (staff of organizations)

Two Sessions of Coach-Delivered Core Transformation for Distress and Well-Being

The goal of this study is to learn if Core Transformation, a guided coaching process, lowers psychological distress in adults. It will also look at well-being, daily functioning, and whether any changes last over time. The main questions it aims to answer are: * Do people who have two Core Transformation sessions have less psychological distress after their second session than people who are still waiting for their sessions? * Do any changes last up to 12 months after the sessions? * Do participants feel better about the issue they chose to work on? Researchers will compare a group that has the sessions earlier with a group that has the same sessions about 2 weeks later (a waitlist group). Participants will: * Choose one moderate issue to work on * Be placed by chance into an earlier-start group or a later-start group * Have two one-on-one online video coaching sessions with a Core Transformation coach (a coach in training or a certified coach), about one week apart. Sessions are recorded. * Complete online surveys before the sessions; at about 4 weeks (after the sessions for the immediate arm, and before the sessions for the delayed treatment arm); at about 6 weeks (after the sessions for the delayed treatment arm); and for long-term follow-up at about 3, 6 and 12 months after the second session. Everyone in the study is offered the sessions.

EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A RCT Study

This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of an ecological momentary intervention (EMI) in reducing psychological distress among young adults with multiple adverse childhood experiences (ACEs). The intervention targets three potentially modifiable transdiagnostic psychological processes: emotional clarity, self-esteem, and catastrophizing. Approximately 100 young adults aged 18-29 years who have experienced at least two types of ACEs and report elevated psychological distress will be recruited. Participants will be randomly assigned in a 1:1 ratio to either the EMI intervention group or the waitlist control group. Those assigned to the intervention group will receive a 2-week smartphone-based EMI delivered in their daily lives. Intervention effectiveness will be evaluated by comparing changes in psychological distress and related psychological outcomes between the two groups.

EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A Feasibility Study

This single-arm feasibility study aims to evaluate the feasibility and acceptability of an ecological momentary intervention (EMI) designed to reduce psychological distress among young adults with high levels of adverse childhood experiences (ACEs). The intervention targets three potentially modifiable transdiagnostic psychological processes: emotional clarity, self-esteem, and catastrophizing. Approximately 20 young adults aged 18-29 years who have experienced at least two types of ACEs and report elevated psychological distress will be enrolled. All participants will receive a 2-week smartphone-based EMI delivered in daily life. Feasibility, acceptability, and safety will be evaluated using recruitment, retention, intervention use, participant satisfaction, perceived burden, and adverse events. Changes in psychological distress and related psychological outcomes from baseline to post-intervention will also be explored as exploratory outcomes.

PICS-p Longitudinal Cohort Study

Children who survive critical illness may develop new or worsening problems with physical health, cognitive status, emotional well-being, and social functioning. These problems, collectively known as post-intensive care syndrome in pediatrics (PICS-p), may also affect family well-being. Evidence on how frequently these problems occur, how they change over time, and which factors influence recovery remains limited in China. This single-center, prospective observational cohort study at Children's Hospital of Fudan University aims to describe the occurrence and recovery trajectories of PICS-p and identify factors associated with persistent difficulties or recovery. The study focuses on children admitted to the pediatric intensive care unit (PICU) with sepsis, severe pneumonia or acute respiratory distress syndrome, those receiving cranial neurosurgical care, and those requiring prolonged mechanical ventilation. Clinical information and standardized assessments will be collected to evaluate physical function, overall quality of life, cognitive function, psychological well-being, social functioning, and family outcomes. Follow-up will include assessments at 1, 3, 6, and 12 months after PICU discharge, with longer-term follow-up planned at 2 years, 3 years, and beyond. The study will examine how outcomes change over time and identify potentially modifiable risk factors. The findings will help identify early which children and families need additional support and guide the development of rehabilitation and coordinated follow-up care across hospital, home, and community settings.

Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation

This study examines online programs for parents navigating divorce or separation. Researchers will study whether a self-guided mindfulness app called Healing Hearts, followed by a self-guided online parenting program called the electronic New Beginnings Program, is feasible and acceptable to parents and shows promising effects on parent and child wellbeing. Ninety-six parents who live in the United States, have a child aged 6 to 18 with a former partner, and report mild to moderate psychological distress will be randomly assigned to one of three groups: Healing Hearts followed by the parenting program, the parenting program alone, or a set of online educational resources. Participants complete online assessments before assignment, about seven weeks later, and about seven weeks after the second assessment. The study measures parent wellbeing, parenting, parent reports of child behavior, program use, and participant experiences. All participation takes place remotely.

Online Therapist-guided Receptive Music Therapy in Adults With Psoriasis

This single-center, three-arm randomized controlled trial evaluated a four-week online therapist-guided receptive music therapy program as an adjunct to treatment as usual in adults with moderate-to-severe psoriasis and clinically relevant psychological or quality-of-life burden. Seventy-five participants were randomized in a 1:1:1 ratio to treatment as usual, treatment as usual plus an audio-based active relaxation control, or treatment as usual plus therapist-guided receptive music therapy. The principal comparison was between the music therapy and active control groups. Dermatology-specific quality of life, perceived psychological stress, anxiety, and depressive symptoms were assessed at baseline, at the end of the four-week intervention, and at three and six months after the intervention. Dermatological severity, treatment adherence, intervention adherence, and other prespecified or documented exploratory measures were also assessed. Alcohol, drugs and nicotine-use information, as well as the Revised Illness Perception Questionnaire 9, are reserved for a distinct secondary exploratory analysis and are not part of the primary efficacy evaluation.

The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project

Many breast cancer survivors (estimated 70% in some studies) experience clinically significant depression and/or anxiety in the months and years after finishing cancer treatments. This research will build on the rigor of prior research to reduce breast cancer survivor depression and anxiety with a compassion meditation intervention called CBCT (Cognitively-Based Compassion Training) for online synchronous delivery that is also inclusive of informal caregivers (i.e., adult family members who live with and typically provide half the care for survivors, aka supportive partners).

Virtual Nature Versus Guided Imagery for Anxiety and Well-Being in Hospitalized Older Adults

Long hospital stays can be difficult for older adults. Being confined to a ward, with limited mobility and little access to the outdoors, may contribute to anxiety, low mood, and reduced well-being. Contact with nature is known to support relaxation and emotional recovery, but hospitalized patients often cannot go outside. This study compares two ways of bringing a nature experience to patients who are staying in hospital. In the first approach, participants wear a virtual reality headset and watch 360-degree videos filmed in real natural settings near Budapest: a meadow, a stream, and a mountain. The nature scene reaches them through their eyes and ears. In the second approach, participants listen to a short recorded audio guide and picture the same three nature scenes in their own minds, with their eyes closed. Here the nature scene is created by their own imagination. Both approaches use exactly the same nature themes. The only difference is how the experience reaches the person: from the outside through the senses, or from the inside through imagination. The study asks whether these two routes have different effects, and whether they can be told apart by measuring heart rate variability, which reflects how the body's automatic nervous system responds. Participants are adults aged 65 or older who have been in hospital for at least two weeks. After joining the study, each participant is first observed for two weeks while receiving only their usual hospital care. This period serves as their own comparison. They are then assigned by chance to one of the two approaches and take part in three sessions over two weeks. Questionnaires and brief cognitive tests are completed at three points: when joining, before the sessions begin, and after the sessions end. The main question is whether anxiety symptoms decrease more during the session period than during the preceding period of usual care. The study also looks at mood, attention and memory, well-being, and resilience.

Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study

The goal of this feasibility study is to learn if the randomised controlled trial evaluating the Remote-delivery Balance in Everyday Life (rBEL) programme for adults younger than 55 years who have experienced a myocardial infarction (MI), is feasible. The objective is to examine the feasibility of the rBEL programme and the associated study procedures before a controlled evaluation of the programme. This is an uncontrolled, single-arm, pre-post treatment designed study. Participants of the target population will take part of the six session over 13 week programme. Feasibility will be evaluated against predefined feasibility criteria regarding study procedures and programme acceptability.

Evaluating the Effectiveness of a School-based Stepped Care Treatment Model for Adolescent Depression in Pakistan

This study aims to test the effectiveness of a stepped-care model to reduce depressive symptoms in adolescents in school settings in Pakistan. The study will examine whether the universal intervention, delivered by non-specialists, can reduce depressive symptoms in adolescents after 3 months. For adolescents who do not improve with universal intervention, the study will assess whether a Cognitive Behavioural Therapy (CBT)-based guided self-help app can provide additional support as a second-step intervention. Six hundred adolescents aged 13-15 from 40 schools in Rawalpindi, Pakistan, will take part. The study will determine which interventions work best and for which students to reduce depressive symptoms in school settings in Pakistan.

Feasibility of a Real-world, Financial Psycho-oncology Intervention to Address Cancer-related Financial Distress

The goal of this pilot, feasibility study is to evaluate the feasibility and preliminary impact of a finance-specific psycho-oncology intervention, as well as to explore perceptions of and experiences with this financial psycho-oncology intervention for patients with cancer experiencing financial hardship. The main questions it aims to answer are: 1. Is this financial psycho-oncology intervention feasible, acceptable, and appropriate for patients with cancer experiencing financial hardship? 2. How can we refine the financial psycho-oncology intervention to best address financial distress for patients with cancer experiencing financial hardship? Patients enrolled in the intervention will receive 2, 60-minute long, finance-specific psycho-oncology sessions per month over the course of 3 months, for a total of 6 sessions over the course of the intervention. Patients will complete surveys during intervention enrollment and after intervention completion to assess secondary outcomes of financial hardship, psychological distress, stress, and anxiety. Individuals who consent to the financial psycho-oncology intervention will also be invited to participate in a 30-minute semi-structured interview to explore their perceptions of and experiences with the financial psycho-oncology intervention, including concepts of participation and engagement, relevance and acceptability, content and understanding, logistics and practicality, and potential impact.

Investigating the (Cost-)Effectiveness of an Online Social Therapy Platform (ENYOY) for Young People Aged 16-25 on Mental Healthcare Waiting Lists

This study, run by Amsterdam UMC in the Netherlands, looks at whether an online mental health platform called ENYOY can help reduce psychological distress in young people aged 16 to 25 who are waiting for mental health care. Young people can take part if they are experiencing mental health problems and are currently on a waiting list for mental health care. The study lasts 12 months. During this time, participants complete questionnaires four times: at the start of the study and after 3, 6, and 12 months. After joining the study, participants are randomly placed into one of two groups: * Intervention group: receives access to the ENYOY platform plus care as usual. * Control group: receives care as usual. Young people in the intervention group can use the platform for the duration of the study, with three months of guidance from a coach and/or a peer with lived experience with mental health problems. The platform includes activities based on proven psychological methods. These activities help with issues such as low mood, anxiety, sleep problems, and low confidence. Participants also have access to a safe online community where young people can talk, share experiences, and support each other. The community is moderated to keep it safe and supportive. Taking part may help reduce psychological distress and improve participants' mental health. There are no known risks associated with taking part in this study. Participant recruitment will take place from May 2026 to December 2027. Final follow-up assessments are expected to be completed by December 2028. The study is funded by ZonMw. For questions, you can contact Sascha Struijs (s.y.struijs@vu.nl) or Fenna Hellegers (f.hellegers@amsterdamumc.nl).

A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers

The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.

Testing an Adaptive Intervention for Peer-Supported Mobile Health for Primary Care Veterans With Psychological Distress

Many Veterans experience psychological distress including depression, post-traumatic stress disorder (PTSD), anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. VA mobile health applications (mHealth apps) that teach skills to manage psychological distress are widely available. However, Veterans rarely use these apps enough to experience health benefits. Peer specialists are VA employees who are trained to use their lived experiences in mental health recovery to help other Veterans. Peers can provide support and accountability to Veterans as they use mHealth apps. Peers working in VA primary care settings are easily accessible to Veterans who receive VA services. This study aims to improve the health of Veterans by testing the effectiveness of peer-supported mHealth in reducing psychological distress. It will also test how much peer support Veterans need to improve their health with using mHealth apps.

Effectiveness of Group-based Positive Psychotherapy and Positive Cognitive Behavioral Therapy in Improving Psychological Distress, Coping Strategies, and Well-being Among Incarcerated Individuals.

The foremost idea of the proposed research is to highlight the impact of psychological distress and coping strategies on the wellbeing of individuals in incarceration. In Pakistan, there is limited literature available to support the psychological wellbeing of individuals in incarceration. The current research will not only explore the impact of psychological distress and coping strategies on the wellbeing of inmates. In addition, the research will also aim to investigate the effectiveness of group-based interventions, which includes Positive Psychotherapy (PPT) and Positive Cognitive Behavioral Therapy (PCBT) in improving psychological distress, coping strategies, and wellbeing of Incarcerated Individuals.

Meditation to Reduce Firefighter Distress

The more than one million firefighters in the United States provide critical emergency medical services in communities they serve and are on the front lines of healthcare delivery, including in the post-pandemic world. As a result of exposure to occupational stressors, a high proportion of firefighters experience considerable stress-related burden including psychological distress (i.e., increased features of anxiety and depression). To address this need, this project will test the efficacy of a 10-day meditation intervention (i.e., 10 individual prerecorded audio units delivered by smartphone app) among career firefighters to decrease psychological distress (i.e., anxiety and depression).