Clinical Research Directory

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.

Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration

The investigators are conducting a randomized controlled trial to assess the impact of Resiliency in Stressful Experiences (RISE) - a comprehensive trauma-based program for young men releasing from a southeastern state's prisons. The investigators are assessing whether treating trauma and providing other transitional supports - such as employment assistance - as young men return home will help to improve their community stability and enhance their psychological well-being, in turn, resulting in less likelihood that a person will become incarcerated in the future.

MB-PAT for Demoralization in Advanced Cancer ('PAT-MIND') Trial

This pilot clinical trial will study psilocybin-assisted therapy for adults with advanced cancer who are experiencing demoralization, existential distress, or related psychological concerns. Demoralization can include feelings of hopelessness, helplessness, loss of meaning, and distress related to illness or end of life. The purpose of this study is to assess whether a hybrid group-based psilocybin-assisted therapy program is feasible, acceptable, and safe in adults with advanced cancer. The study will also explore which combination of psilocybin dose and psychotherapy approach may be most promising for a future larger trial. Participants will be randomly assigned by wave to one of four intervention combinations: 25 mg psilocybin with mindfulness-based psilocybin-assisted therapy, 25 mg psilocybin with standard psilocybin-assisted therapy, 5 mg psilocybin with mindfulness-based psilocybin-assisted therapy, or 5 mg psilocybin with standard psilocybin-assisted therapy. The psilocybin dose will be blinded, meaning participants and some members of the study team will not know which dose was assigned. Psychotherapy approach will not be blinded. The study will enroll at least 60 participants across Calgary and Kingston.

Italian YOLO: A Web-Based ACT Mental Health Promotion Intervention for University Students

The mental health of university students requires urgent attention, as many students are exposed to increased risk of psychological distress, including symptoms of depression, anxiety, academic stress, and reduced well-being. Although many students experience mental health difficulties, most do not seek help. University counselling and health services may also face increasing demand and limited resources to meet students' needs. Acceptance and Commitment Therapy (ACT) is a transdiagnostic psychological approach that aims to increase psychological flexibility. Rather than focusing only on symptom reduction or problem solving, ACT helps individuals develop a more flexible relationship with difficult thoughts and emotions, clarify personally meaningful values, and engage in committed action. However, access to traditional psychological interventions may be limited by long waiting lists, time constraints, conflicts with academic schedules, high costs, stigma, and shortages of trained professionals. Web-based interventions may help reduce these barriers by providing accessible and flexible support that students can complete privately and at their own pace. Previous research suggests that ACT can be effectively adapted to online formats and may improve mental health and well-being outcomes in university student populations. The present study aims to evaluate the effectiveness of the YOLO web-based ACT intervention among students at the University of Bologna. Participants will be allocated to either immediate access to the YOLO program or a waitlist/delayed intervention condition. Outcomes will be assessed at baseline, post-intervention, and follow-up assessments, including psychological flexibility, depression, anxiety, psychological well-being, academic performance, academic self-efficacy, resilience, and purpose in life. The study will examine whether changes in psychological flexibility are consistent with the theoretical basis of the program. It will also assess the feasibility, acceptability, and usability of the intervention to inform its potential dissemination in other Italian higher education contexts. In addition, exploratory analyses will examine caregiving responsibilities among students with caregiving roles and assess whether caregiving demands are associated with mental health, well-being, and academic functioning.

A Hybrid Effectiveness Implementation Study of Latino/a Alcohol and Drug Users

Alcohol use is a significant problem among Latinxs and immigration-related stress increases risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of immigration-related stressors (e.g., stigma, social isolation) resulted in significant reductions in alcohol-related harms for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious addiction interventions are not common, yet are needed to advance implementation science. This Hybrid Type 1 Effectiveness-Implementation study will investigate the feasibility of implementing CAMI in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus a booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol-related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from this Hybrid study to the broader community to focus on population health for all primary care patients.

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.

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

Many Veterans experience psychological distress including depression, 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.

Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers

The primary objective of this study is to evaluate the ability to recruit and retain participants, and to successfully conduct a psilocybin-based protocol, for a study of the treatment of distress related to stage IV or inoperable gastrointestinal cancers. Secondary objectives include pre/post, and longitudinal measurement of distress in intervention participants and a paired family member who is in an observational arm.

Musical Group Intervention for Children in Shelters

The aim of the study is to augment knowledge on interventions for children who live, or have lived, in shelters after exposure to domestic violence. Research questions concern the feasibility of a music group intervention for children. The experiences of children, caregivers, and professionals will be investigated. Additionally, outcomes concerning emotional reactivity, capacity for emotional regulation, quality of life, and psychological health will be evaluated.

Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students

The goal of this trial is to investigate the effect of freeze-dried table grape powder (FTGP) on psychological distress and gut microbiota in college students. The main questions it aims to answer are: Does FTGP reduce anxiety, depression, and perceived stress? Does FTGP improve the gut microbiota? Researchers will compare FTGP to a placebo to see how FTGP affects psychological distress and gut microbiota. Participants will: Drink a daily supplement containing FTGP or a placebo for 4 weeks. Record consumption of grape powder or placebo in a compliance log. Complete surveys and provide stool samples. Three in-person visits.

Bridging the Gap in Psychosocial Care for Cancer Survivors

The study aims to assess the feasibility and acceptability of the implementation of a routine digital psychosocial screening combined with a psycho-oncological Navigation Call for cancer survivors after completion of primary treatment with the goal to improve identification of psychosocial needs and facilitate access to supportive care.

Impact of Mindful Self-Compassion Therapy on Self Harm Behaviors, Emotional Regulation and Quality of Life Among Patients With Borderline Personality Disorder

The primary purpose of the study is to investigate whether Mindful Self-Compassion (MSC) therapy can significantly reduce self-harm behaviors, improve emotional regulation, and enhance the quality of life in individuals diagnosed with Borderline Personality Disorder (BPD). The study aims to contribute to the existing literature by providing robust evidence on the efficacy of MSC therapy for BPD, which could inform clinical practices and improve treatment outcomes

Transcranial Magnetic Stimulation for Psychological Distress in Patients With Advanced Illness

Psychological and existential distress are a common cause of suffering among patients nearing the end of life, and a major reason for requesting medical aid in dying. Existing treatments for psychological and existential suffering have low efficacy and are challenging to use in a palliative context. There is a need to develop scalable, brief, and rapidly effective therapeutic approaches that can reduce psychological and existential distress in patients nearing the end of life. Repetitive Transcranial Magnetic Stimulation is an effective treatment for refractory depression, and new protocols and increasing availability of rTMS may make this therapy feasible and acceptable for patients who suffer from psychological or existential distress near the end of life. Among patients with advanced illness followed by a PC provider, the study objectives are to: 1. Identify the lowest and range of therapeutic rTMS dose to relieve psychological distress, including an analysis of clinical predictors of response. 2. Test the feasibility and preliminary efficacy of rTMS for the treatment of psychological distress including: 1) ease of recruitment; 2) completion of follow-up; 3) effect size and variance estimates of treatment for primary and secondary outcomes; and 4) patient satisfaction with treatment. This study is a phase 2a dose-finding open-label clinical trial, followed by a phase 2b prospective, sham-control or sham-crossover study, depending on the therapeutic dose identified in phase 2a. The investigators will enroll eligible patients from an inpatient palliative care unit and administer rTMS according to established best practice international guidelines. Two screening tests will be conducted (one completed by patient and another by the treating physician) to ensure the patient has no contraindications to rTMS. In the open-label dose-finding study, investigators will determine the appropriate dose of treatment that leads to positive patient outcomes, assess characteristics associated with positive and rapid response to rTMS, and examine if this treatment is feasible and acceptable to patients by measuring rates of enrollment and completion of the treatment sessions. Based on results from this first phase, a phase 2b feasibility and preliminary efficacy randomized clinical trial will be conducted to measure the effect of rTMS by comparing patient symptoms before and after the rTMS intervention.

EMDR Group Therapy for Posttraumatic Stress Symptoms in Migrants

The goal of this randomized controlled trial is to evaluate the effectiveness and feasibility of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) in migrants with posttraumatic stress symptoms attending an adult education center (CPIA Salerno) in Italy. The main questions it aims to answer are: * Do participants who receive the EMDR-IGTP-OTS intervention show greater reductions in posttraumatic stress symptoms compared with participants assigned to a control condition? * Does the intervention lead to improvements in psychological distress and broader psychological functioning over time? * Is the EMDR-IGTP-OTS intervention feasible in an adult education setting, as indicated by treatment completion and adherence to the intervention protocol? Researchers will compare participants receiving the EMDR-IGTP-OTS group intervention with participants assigned to a control condition to determine whether the intervention is effective in reducing posttraumatic stress symptoms and psychological distress. Participants will: * Complete questionnaires assessing posttraumatic stress symptoms and psychological distress before the intervention, after the intervention, and at follow-up. * Participate in four structured group sessions of EMDR-IGTP-OTS delivered on consecutive days. * Be monitored for treatment completion and protocol adherence throughout the intervention period.

Impact of a Climate-Adapted Self-Management Intervention for Hypertension: A Randomized Controlled Trial Examining Psychosocial and Environmental Determinants

This study aims to evaluate the effectiveness of a Climate-Adapted Self-Management Intervention in improving the quality of life among adults with hypertension. The study employed a two-phase design comprising a cross-sectional survey followed by a randomized controlled trial. The intervention was evaluated for its effects on quality of life, psychological distress, health behaviors, environmental determinants, and blood pressure.

Psychopharmacological Treatment of Emotional Distress

This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the Suicide Crisis Syndrome (SCS). All participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. The primary outcome measure is SCS at discharge and one-month follow-up. The secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.

Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis

The goal of this randomized controlled trial is to evaluate the effectiveness of a digital psychoeducational intervention for young adults experiencing fertility-related distress following a cancer diagnosis. It will also assess how the intervention supports the development of effective coping strategies and social support networks. The main questions it aims to answer are: Does the digital psychoeducational intervention reduce anxiety and depression severity compared with usual care? Does the digital psychoeducational intervention increase patients' self-efficacy, social support, and coping compared with usual care? Does the digital psychoeducational intervention increase patients' quality of life compared with usual care? Researchers will compare the digital psychoeducational intervention to usual care (standard treatment) to see if the intervention effectively manages psychological problems and improves quality of life. Participants will:Be randomly assigned to either the experimental group or the control group. Attend an initial face-to-face introductory session, followed by four digital psychoeducational modules delivered via a mobile phone application (if assigned to the experimental group). Engage with module content including an e-booklet, video, and quizzes, with a new module opening every two days. Receive standard treatment from healthcare providers, and later receive the psychoeducational materials at the end of the data collection period (if assigned to the control group). Complete a series of validated questionnaires measuring depression, anxiety, coping, self-efficacy, social support, and quality of life at four different time points throughout the study.

Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder

This study aims to evaluate the feasibility of a culturally adapted, nurse-led Creating Opportunities for Parent Empowerment (COPE) intervention to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) in Pakistan. The study will use an exploratory sequential mixed-methods design comprising a qualitative needs assessment followed by a pilot randomized controlled feasibility trial. Qualitative interviews will identify caregivers' training needs and inform the cultural adaptation of the COPE intervention. Eligible caregivers will then be randomly assigned to either an intervention group receiving the culturally adapted COPE program in addition to routine care or a control group receiving routine care alone. The intervention consists of four weekly nurse-led sessions focusing on psychoeducation, cognitive restructuring, coping strategies, positive parenting, emotional regulation, and family resilience. Psychological wellbeing will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21) at baseline and one month after the intervention. The study will also evaluate recruitment, retention, intervention adherence, acceptability, and implementation feasibility to inform the design of a future definitive randomized controlled trial.

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.

Ecological Momentary Intervention (E-Breathing) to Reduce Psychological Distress in Adolescents

A two-arm randomized controlled trial (RCT) will be conducted to test a mobile-based intervention, E-breathing, for early detection and intervention to address psychological distress in at-risk adolescents in Hong Kong. E-breathing harnesses the science of real-time, in-situ assessment approach - Ecological Momentary Assessment (EMA) - to capture the psychological symptoms and needs of adolescents. Based on the real-time data collected via smartphone, the mobile application prompts the practice of slow-paced breathing as an Ecological Momentary Intervention (EMI) to reduce psychological distress. This RCT will recruit a total of 100 participants who will be randomly allocated to either (1) an intervention group (EMI group), where they will receive a feedback prompt when they score high on negative affect (i.e., E-breathing) or (2) the control group (EMA group), where they will only complete EMAs without feedback. This project aims to investigate the feasibility and effectiveness of E-breathing in improving psychological symptoms in Hong Kong adolescents. This project also examine the underlying physio-mechanisms of the effects of E-breathing on psychological outcomes in this target population.

Effect of Mandala Art Therapy on Childbirth Fear and Anxiety in Expectant Fathers

This randomized controlled trial is designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor. Eligible participants will be randomly allocated to either the intervention or the control group. Fathers assigned to the intervention group will participate in a single 20-25-minute mandala art therapy session, whereas those in the control group will receive standard care without any additional intervention. Childbirth fear and state anxiety will be assessed using the Fathers' Birth Fear Scale and the State subscale of the Spielberger State-Trait Anxiety Inventory, respectively, at baseline and immediately following the intervention. The findings of this study are expected to provide evidence regarding the effectiveness of mandala art therapy as a non-pharmacological intervention for alleviating childbirth-related fear and anxiety among expectant fathers.

Mindfulness Training and Respiration Biosignal Feedback - Study 2

The goal of this research is to test usability and user satisfaction with a new breathing feature on the meditation app, Equa, to help young adults who are distressed, understand their physiological responses and mindfulness skill development during meditation. Our main aims are to test an algorithm that can use physiologic signals to give feedback about how participant physiology is changing during guided lessons on the meditation app, Equa through: * Assessing user satisfaction and usability * Measuring how much participant mindfulness skills are improving Participants will: * Complete a survey about demographics, their thoughts and feelings before and after the mindfulness meditation program * Complete 14 smartphone guided mindfulness meditation training units while physiological measures are being recorded * A subset of participants will see a graph tracking their physiological responses from the guided meditation lesson and predictive mindfulness skill scores * Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills

STEPS - Stress Training and Engagement Via Phone-Based Systems

This study will evaluate engagement, usability, and psychological outcomes associated with participation in smartphone-based stress management or mindfulness training program among young adults. The study will compare multiple versions of a digital training program delivered through the Equa mobile application. Participants will be individually randomized to one of several app-based training programs using a stratified randomization procedure. Each program consists of guided daily lessons completed over a 14-day period and is designed to support stress management and well-being through structured skill development activities. Primary objectives include evaluating user satisfaction and usability of the digital platform and assessing changes in mindfulness-related skills and mental distress over time. Participants will: Complete surveys assessing demographics and psychological well-being at baseline, post-intervention, and one-month follow-up. Complete a 14-day smartphone-delivered training program consisting of guided lessons while physiological data are collected using wearable sensors. Some participants may receive additional in-app features designed to support personalized learning or engagement with training lessons. Some participants will complete brief questionnaires before and after selected lessons to assess short-term changes associated with lesson participation.

CARE-BI:a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During IA Removal

The goal of this research study is to learn about the rate of posttraumatic stress disorder (PTSD) experienced by women after undergoing gynecologic brachytherapy.