Clinical Research Directory

Stress Management and Life Satisfaction in University Students

This study aims to examine the effects of a structured psychoeducational program on the psychological well-being of university students. Participants will be randomly assigned to either a psychoeducational group or a control group. The psychoeducational program includes sessions designed to improve stress coping skills. Data will be collected using self-report questionnaires administered after the intervention. The study does not involve any drugs or medical devices and is considered to be of minimal risk. The findings are expected to contribute to the development of effective psychosocial interventions for young adults.

Cognitive Remediation Intervention to Prepare for Transition of Care

Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention to prepare adolescents with sickle cell disease for transition of care.

Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years

This research aims to ask (1) Are child and parent measures of coping skills, anxiety and other outcomes reliable (2) How feasible and acceptable is the proposed CB preventative program and protocol (3) Can a preliminary indication of efficacy for CB preventative program be provided.

Effectiveness of a Waitlist App "Stappvoorstap" During Mental Healthcare Waiting Times

This study evaluates the effectiveness of Stappvoorstap, a mobile self-management application designed for adults on mental health waiting lists in the Netherlands. The app helps users monitor daily stress levels, recognize personal stress patterns, and provides coping strategies, relaxation exercises, and supportive resources. Using a multiple baseline single-case experimental design, participants use the app for 4 weeks while completing weekly questionnaires measuring perceived stress, coping self-efficacy, and quality of life. The study aims to determine whether the app can reduce stress and improve wellbeing during the waiting period before mental healthcare treatment begins.

Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)

Affecting nearly 800,000 people in the US every year, stroke is a leading cause of long-term disability, and has serious consequences for stroke survivors and their carepartners. Our project uses a scientifically rigorous efficacy study to evaluate a remotely delivered 8-week dyadic (couples-based) positive psychology intervention to reduce emotional distress in stroke survivors and their carepartners. If successful, couples may be better emotionally equipped to cope with the sequelae of stroke, and have better rehabilitation outcomes and quality of life.

Factorial Optimization Trial to Test Effects of Coping Intervention Components

This study will identify components for inclusion in a coping intervention package to reduce mental health problems among children exposed to high interparental conflict after parental separation/divorce. Reappraisal, distraction, and relaxation coping strategies are related to fewer mental health problems among children, making intervention components based on these strategies key candidates for inclusion in an optimized coping intervention. The primary aim is to experimentally assess the main and interactive effects of three digital intervention coping components (reappraisal, distraction, relaxation) on children's coping efficacy, emotional security, and internalizing and externalizing problems. Secondary aims are to assess indirect effects of the intervention components on children's coping efficacy, emotional security, and internalizing and externalizing problems through their cognitive, emotional, and behavioral reactions to post-separation/divorce interparental conflict events.

Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.

Multidisciplinary Intervention In Chronic GVHD

This research is being done to evaluate the feasibility and efficacy of a multidisciplinary, patient-centered intervention, Horizons Program, versus minimally enhanced standard care to improve quality of life, symptom burden and psychological distress of adults who received an allogeneic hematopoietic stem cell transplant and developed graft versus-host disease (GVHD).

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.

NeuroPathways Intervention for Brain Tumor Patients

This goal of this study is to test an information and support intervention for patients with malignant (or "high-grade") brain tumors. This study was developed to help patients cope after a brain tumor diagnosis. The main question this study aims to answer is whether this intervention (which includes access to an information guide and one-on-one coaching sessions) is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in the coaching sessions, use the guide as desired, and complete a small group of short surveys at three different points in time; some participants will be asked to share feedback via exit interviews.

Forging Hopeful Futures to Reduce Youth Violence

This cluster-randomized community-partnered study will examine the effectiveness of a racial-, gender-, and economic-justice focused youth violence prevention program called Forging Hopeful Futures with youth ages 13-19.

Horizons Chronic Graft-Versus-Host-Disease Study

This research is being done to evaluate the feasibility of the Horizons Program, a group-based behavioral intervention, to enhance quality of life in patients with chronic graft-versus-host disease.

ASCENT Intervention for Brain Tumor Patients

The goal of this study is to refine and test a psychosocial intervention called ASCENT (ACT-based Supportive intervention for patients with CENTral nervous system tumors). This intervention was developed to help patients after being diagnosed with a brain tumor. The main question this study aims to answer is whether this intervention is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in 6 coaching sessions and complete short surveys at four different time points. Some participants will be asked to share feedback via interviews.

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

Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients

Cancer represents the second cause of death in general population worldwide and according to statistics, it is expected to increase in the next 20 years. Cervical cancer is the fourth cause of morbidity and mortality among women around the world. Late diagnosis and treatment indices several emotional reactions in patients leading to psychological disorders with an impact in quality of life. Anxiety and depression are the most frequent emotional reactions in cancer patients, which may vary depending on psychosocial factors such as coping and family support, mostly provided by the primary caregiver. Despite the high psychological morbidity in cancer patients, it is estimated that, among those patients needing psychological support, only 10% receive such interventions. A growing interest on psychological interventions in oncology has increased in the last 40 years, however, scarce investigations have been performed, especially in cervical cancer patients. The Cognitive-Behavioral Therapy has proven to be beneficial in general cancer population decreasing the psychological symptoms and improving the quality of life. Thus, the aim of this study is to evaluate the effect of two Cognitive-Behavioral psychological interventions on anxiety, depression, coping, therapeutic adherence, sexual satisfaction and quality of life of cervical cancer patients with locally-advanced and advanced disease attended at the National Cancer Institute from Mexico. Psychological intervention will be provided during ten weekly sessions including psychoeducation, relaxation, cognitive restructuring and problem solving with a pretest, posttest performed one week after intervention, and finally a follow up after three months after finishing the psychological intervention.

Feasibility of the 5-Step Method in the U.S.

The purpose of this study is to see if it is possible (feasible) to introduce a behavioral intervention for family members affected by a relative's misuse of drugs and/or alcohol in the United States. The intervention is called the 5-Step Method. It will be a randomized control trial, with a total of 36 participants, and 18 in each group. The study lasts for approximately 12 weeks for the participant. The intervention group will receive a self-help handbook of the 5-Step Method, and the control group will not. Although the control group will not receive an intervention from the research team, they are allowed to look for and use any currently available program for affected family members (for example, Al-Anon, or Nar-Anon) during the study period. The study is being done because the 5-Step Method has not been used or evaluated in the U.S. (or the creators are unaware that it is in use here). There are two aims (objectives): (1) to see if it is feasible to introduce the 5-Step Method into the U.S.; (2) to look at trends in the baseline and followup survey scores to see if there is evidence of preliminary participant response.

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.

An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth

AFFIRM is an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among SGMY. AFFIRM is delivered by two facilitators (primarily social workers and peers) through a combination of education and rehearsal (i.e., simulation of real-life experiences) in a manner that affirms participants' sexual and gender minority identities and experiences. AFFIRM is being tested in a five-year trial using a stepped wedge waitlist crossover design, where all participants receive the intervention in clusters.

The Group Risk Reduction Intervention Therapy (GRRIT) Project

Investigators will evaluate a group format adaptation of Brief Cognitive-Behavioral Therapy for Suicide (i.e., G-BCBT) on suicide ideation (Aim 1), ability to use coping strategies (Aim 2), and overall mental health (exploratory analysis). The combination of tailored means safety counseling and training in evidence-based emotion regulation and cognitive flexibility skills delivered via a 12-session group therapy treatment will decrease service members' overall suicide risk. The group format will provide opportunities to learn and practice skills, thereby enhancing self-efficacy. G-BCBT outcomes are expected to be no worse than Dialectical Behavior Therapy (DBT) group skills training, an existing gold standard intervention that is twice the length of time as G-BCBT.

The Effect of Laughter Yoga-Supported Strong Woman, Safe Life Training Program on Attitudes Towards Violence, Styles of Coping with Stress and Psychological Flexibility

The aim of this project is to examine the effects of the Laughter Yoga Supported Strong Woman, Safe Life Education Program applied to women on attitudes towards violence, stress coping styles and psychological flexibility. The problem of violence against women is a public health problem that affects and concerns not only women at the individual level, but also children, all family members and therefore society. According to the data of the Turkish Statistical Institute in our country, 38% of women have been subjected to spousal or partner violence at some point in their lives. Violence or the threat of violence that causes fear, pain and anxiety in women from an individual perspective; constitutes an obstacle to women's more active and productive participation in economic and social life, especially in the private sphere. From a social perspective, the economic cost of violence against women is extremely high in terms of loss of working hours and wages, social services, legal and medical expenses. Our country has a culturally patriarchal social structure. Living in a patriarchal order affects beliefs and attitudes towards the acceptance of violence, making women more vulnerable to violence. Living in a patriarchal order affects beliefs and attitudes towards acceptance of violence, making women more vulnerable to violence. When the reasons for submissive behaviors towards violence are examined, it is stated that factors such as having children, low self-esteem, religious beliefs, social pressure, emotional attachment to a long-term relationship, running away from home, arranged marriage, being economically dependent on the spouse and low level of education are effective. Accepting violence encourages aggression and causes violent people to legitimize their actions. It is stated that submissive and accepting attitudes towards violence can be changed. Interventions aimed at empowering women play an important role in reducing attitudes accepting violence. It is anticipated that this project will create an opportunity for women to raise awareness about violence and change their accepting attitudes towards violence. The proposed project consists of THREE stages. The first stage, PREPARATION stage; includes preparation of data collection tools, determination and informing of scholarship recipients, development of training content and tools, preliminary application and determination of the working group. The second stage is the IMPLEMENTATION stage, which includes collecting pre-test data, loading public transportation fees onto participants' cards for transportation, providing training to the intervention group, and collecting post-test data. The third stage is the MONITORING-EVALUATION stage, which is the stage of collecting follow-up test data and conducting analyses. The research will be conducted as a randomized controlled parallel group intervention study. The universe of the research will consist of 7988 women registered in 24 Women's Education and Culture Centers (KEKM) affiliated with Altındağ Municipality. 1 center will be randomly selected from 24 Women's Education and Culture Centers for the sample of the research. In this study, the smallest sample size was determined as 43 for each group, totaling 86, at 80% statistical power and α=.05 significance level. Considering the 10% data loss in the determined sample size, it was planned to include a total of 94 participants, 47 for each group. The assignment of the women included in the research to the intervention (47 participants) and control (47 participants) groups will be done by randomization method. The aim is to implement the Laughter Yoga Supported Strong Woman, Safe Life Training Program face-to-face for an 8-week period for the participants in the intervention group. The 47 participants in the intervention group will be divided into 3 separate groups (16 participants, 16 participants and 15 participants) to increase interaction and experience sharing. The project team will implement the Laughter Yoga Supported Strong Woman, Safe Life Training Program consisting of 8 modules to 3 separate groups. The intervention group will be given a pre-test before the training, a post-test after the training and a follow-up test 1 month after the training is completed. It is planned to collect data by conducting a pre-test, post-test and follow-up test simultaneously with the experimental group without any intervention for the control group. Data will be collected using the Attitude Towards Violence in Close Relationships Scale, the Psychological Flexibility Scale and the Styles of Coping with Stress Scale. Institutional permission will be obtained from the Ankara University Ethics Committee and the Altındağ Municipality. In this project, with the "Strong Woman, Safe Life Training Program Supported by Laughter Yoga", women will be provided with training on the Importance of Self-Knowledge and Communication, Stress and Coping Techniques, Gender, Empowerment

Influence of Relaxing Breathing Before Each Station of an Objective Structured Clinical Examination

SObjective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students. The aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.

The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer

The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to: 1. Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback. 2. Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care. Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.

Effectiveness of Interventions to Improve Resiliency & Burnout in Behavioral Health Residential Staff

The goal of this clinical trial is to compare Integrated Resiliency Training and Task Sharing (IRTTS) to Workplace Improvement Learning Collaborative (WILC) in group homes for adults with serious mental illness and/or intellectual and developmental disabilities. The main questions it aims to answer are: * Is IRTTS superior to WILC in improving residential care worker (RCW) resiliency; stress management and burnout; depression and anxiety; and positive health behaviors? * Is IRTTS superior to WILC in improving RCW turnover/retention; RCW sick days/absenteeism; and group home safety and resident incidents? * What are the barriers, facilitators, and resources required to successfully implement IRTTS and WILC? Participants may engage in training sessions, collaborate with residents and other RCWs in their group homes, attend meetings with RCWs from other group homes, complete surveys, participate in focus groups, and/or give qualitative interviews. Researchers will compare IRTTS to WILC to see which intervention should be implemented to achieve the greatest improvement in RCW resiliency and greatest reduction in burnout and turnover in group homes for adults with serious mental illness and/or developmental and intellectual disabilities.