Clinical Research Directory

Gender Differences in Depression Severity, Gender-Sensitive Symptoms, Resilience, and Stigma in Major Depressive Disorder

Depression is a common and serious mental health condition that affects mood, thoughts, behavior, and overall quality of life. It arises from a complex interaction of biological, psychological, and environmental factors. While depression is more frequently diagnosed in women, research suggests that men may experience and express depressive symptoms differently. Men are more likely to display symptoms such as irritability, anger, impulsivity, or increased alcohol use, and they may be less likely to seek professional psychological support due to social expectations and fear of stigma. Stigma-both self-stigma (internalized negative beliefs about having a mental illness) and perceived social stigma (concerns about being judged by others)-can negatively influence individuals' willingness to seek help and adhere to treatment. In addition, psychological resilience, defined as the ability to cope effectively with stress and adversity, may play an important role in how individuals experience depressive symptoms and respond to treatment. This study aims to compare women and men diagnosed with Major Depressive Disorder in terms of depression severity, gender-sensitive depressive symptoms, self-stigma, perceived social stigma, and levels of psychological resilience. It will also examine the relationships among these factors to better understand how gender-related differences influence the experience and management of depression. Findings from this study may contribute to improved recognition of gender-specific features of depression, reduction of stigma, and the development of more individualized and effective mental health interventions for both women and men.

Study: Tea(m)Time - Strengthening the Team Resilience of Hospital Staff Through the Tea(m)Time Intervention

Employees in hospitals are exposed to various stressors and can be at risk of psychological stress. To counteract this, resilience programs are increasingly being offered. Most interventions focus on individual resilience. In this study, the focus is on the resilience of teams. For this reason, this research paper will focus on the Tea(m)Time intervention. Tea(m)Time is a health promotion intervention that combines the risk assessment of mental stress with a focus on team resilience. In order to generate knowledge about the Tea(m)Time intervention, this study aims to identify factors that promote and inhibit its implementation and mediate its effectiveness. The aim is to gain insights into the promotion of resilience in teams. The aim is to conduct the survey of the participants in the intervention group and the control group at three different points in time.

Building Community Resilience Program

Established in 2021, NYCEAL consists of approximately 40 organizational partners and 120 Community Health Workers (CHWs). Over the next four years (2024-2028), NYCEAL will work with this network to implement the following intervention: Building Community Resilience Program (BCR). To assess the impact of this intervention, an implementation research framework will be used, and pre- and post-surveys conducted, and other process evaluation measures collected. Changes in outcomes measures such as stress, resilience, overall wellbeing, and other related outcomes for participants in the BCR program will be measured for community healthcare workers and/or frontline workers that receive educational workshops.

Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities

The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are: * Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy? * Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy? * Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term? Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term. Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care. All participants will be asked to: * complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device. * complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit. People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as: * a stress reduction toolkit; * access to an online website that can also be downloaded as a smart phone app; * the option to receive an electronic massage while in clinic, and more. * additional support gifts provided at routine clinical appointments People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.

Game Intervention for Resilience

The goal of this clinical trial is to learn if a game-based intervention can enhance psychological resilience and promote positive affectivity in adults who have experienced major life stress. The main questions it aims to answer are: * Does the game-based intervention improve positive affectivity and mental health compared to a waitlist control group immediately after the intervention and at 3-month follow-up? * Are the mental health benefits of the game-based intervention mediated by improvements in positive affectivity over time? Researchers will compare the game-based intervention to a waitlist control group to see if the game leads to better emotional and mental health outcomes. Participants will: * Be randomly assigned to either the game-based intervention group or the waitlist control group * Engage with the assigned program for 10 days within two weeks * Complete psychological assessments before and after the intervention, and again at 3-month follow-up

How a Resilience-Focused Intervention is Perceived by Women Subjected to Domestic Violence

At Uppsala University Hospital, there is an outpatient clinic for women subjected to intimate partner violence. In order to explore how patients experience the biopsychosocial resilience-based intervention in use at the clinic and how well the intervention fits the needs of the patients, 30 patients from different stages of their contact at the clinic and with diverse life situations and background are enrolled. The researchers will carry out individual in-person interviews, each lasting approximately 60 minutes, based on a semi-structured set of questions. The questions concern the participant´s life situation, resilience and self-perceived needs, how well the intervention has met those needs and how it was perceived by the participant. The interviews are audio-recorded and transcribed verbatim for thematic analysis.

CesiKids Trial: Enhancing Psychological Resilience in Adolescents With Cancer

This study will develop and evaluate a mobile-based co-design intervention (CesiKids) to enhance psychosocial resilience in hospitalized adolescents aged 12-18 diagnosed with cancer. The program will be created using Bronfenbrenner's Ecological Systems Theory and designed in collaboration with nurses, recovered adolescents, and parents. A randomized controlled design will be used. The intervention group will participate in a four-week structured program, while the control group will receive standard care. Psychosocial resilience and coping outcomes will be assessed at baseline, post-intervention, and follow-up. This research aims to offer an evidence-based, scalable model to support resilience among adolescents with cancer in clinical settings.

Enhancing Resiliency and Optimizing Readiness in Military Personnel

Security Force Assistance Brigades (SFABs) are specialized United States Army units formed to train, advise, assist, enable and accompany operations with allied and partner nations. Security Force Assistance Brigades are composed of roughly 800 senior military personnel, primarily commissioned and non-commissioned officers selected from regular Army units across a wide range of military specialties. Because of the high operational tempo (OPTEMPO) of these units, individual resiliency is of utmost importance in maintaining readiness to successfully execute critical, high-stress missions. Acceptance and Commitment Training (ACT) is an evidence-based intervention with strong potential to enhance resiliency by bolstering psychological flexibility along with other factors which have been demonstrated to optimize individual and group performance. This project will compare an Acceptance and Commitment Training-based resiliency-enhancement training program as compared to training as usual in 600 3rd Security Force Assistance Brigades soldiers stationed at Fort Hood in Killeen, Texas. Assessment measures related to resilience will be administered before and after training as well as before and after deployment. Assessments will be conducted at baseline, and every 4 months thereafter for a total of 16-months.

Combined Intervention of Long-term Letter Mentoring and Centralized Summer Camp by University Student Volunteers for Disadvantaged Children: A Randomized Controlled Trial

The goal of this clinical trial is to learn if a combined intervention of summer camp and letter-writing support works to improve psychological resilience in disadvantaged adolescents in Liangshan, Sichuan. The main questions it aims to answer are: Does the "summer camp + letter-writing" intervention improve resilience in adolescents who face poverty, lack of parental care, or social risks? Does this intervention reduce depression and anxiety symptoms? Researchers will compare adolescents who join the summer camp and receive monthly letters to those who do not receive this program to see if the intervention helps their mental health and coping skills. Participants will: Attend a 5-day summer camp that includes group games, emotion expression activities, life education, and learning support Receive monthly letters from trained university student volunteers for about 10 months after the camp. The letters will encourage them, give advice, and help them practice what they learned in the camp Complete surveys about their resilience, depression, and anxiety before the intervention, during it, at the end, and 6 months later This study will also look at whether the program is cost-effective, meaning if it brings mental health benefits at a reasonable cost.

Resilience in Adolescent Development

RAD is a 10-year natural history, longitudinal, prospective assessment study of a cohort of 2,500 participants (ages 10-24 years) that will help uncover the socio-demographic, lifestyle, clinical, psychological, and neurobiological factors that contribute to resilience among children, adolescents, and young adults at-risk for mood and anxiety disorders. As this is an exploratory study, we will assess a comprehensive panel of carefully selected participant specific parameters, including socio-demographic, life habits, clinical, biological, behavioral, neurophysiological, and neuroimaging. The study is designed to observe and collect factors associated with resilience in a non-invasive fashion; no interventions or treatments will be conducted during the project. Assessments will be conducted up to 4 times per year for up to 10 years, as well as a baseline visit. Study visits will be conducted in person whenever feasible but may be completed by phone/mail/computer, if an in-person visit is not possible.

The Lasting Change Study

The study approach is to leverage the most cutting-edge techniques of multi-omics biology, wearable physiology, and digital real-time psychology profiling and using machine learning models to understand the mechanisms underlying the strategies and techniques that enable participants the power to initiate and maintain sustainable behavior change. Over the years, millions of people worldwide have attended immersive personal development seminars aiming to improve participants' health behaviors and wellness. Nevertheless, there's a scarcity of large-scale studies to assess their effects on behavior change and investigate their mechanism of action. A recent publication by the Science of Behavior Change Program (SOBC), launched by the National Institute of Health (NIH), recognized that: "science has not yet delivered a unified understanding of basic mechanisms of behavior change across a broad range of health-related behaviors, limiting progress in the development and translation of effective and efficacious behavioral intervention." As such, understanding the mechanisms underlying sustainable behavior change is key.

Effectiveness of Positive Psychological Intervention on Resilience Improvement in Nurses

The nursing profession, comprising over 27.9 million individuals and representing 59% of the health sector, plays a critical role in frontline healthcare globally. However, nurses face significant workplace stress due to factors like high mortality rates and ethical dilemmas, which can negatively impact their mental health. Resilience has emerged as a crucial concept in mitigating workplace stress and protecting nurses' psychological well-being. Studies show a negative correlation between stress and resilience, with higher resilience linked to better psychological outcomes and lower rates of burnout. Resilience, a dynamic process of positive adaptation to stress, can be enhanced through interventions like positive psychology, which focuses on developing traits such as perseverance, interpersonal skills, and emotional stability. These interventions have been shown to reduce burnout, improve job satisfaction, and potentially enhance patient care, making them vital in addressing the unique challenges nurses face. Gap of Knowledge: Although existing research has demonstrated the effectiveness of positive psychology interventions in reducing depression, anxiety, burnout, and stress among healthcare workers, including nurses, there is a need for more targeted randomized controlled trials (RCTs) that specifically address the unique stressors and work environments of nurses. Furthermore, the long-term effects of these interventions on nurses' resilience, stress, burnout, and job satisfaction require further exploration through well-designed RCTs. Research Aims and Hypothesis: The present study aims to 1. evaluate whether a positive psychology intervention, based on evidence-based activities from several positive psychology theories, can improve resilience in nurses, and 2. assess whether this intervention can also enhance stress levels, reduce burnout, and improve job satisfaction among nurses. The hypotheses are: 1. the positive psychology intervention will improve nurses' resilience; 2. the intervention will positively impact stress, burnout, and job satisfaction; and 3. it will be more effective for nurses with low resilience in improving these outcomes.

Resilience and Obesity Prevention in Adolescents

A cross-sectional observation study to see the associations between factors contributing to obesity , resilience, and HRQoL in Indian adolescents. Study objectives : 1. To classify consenting adolescents into normal, underweight, overweight, and obese groups. 2. To assess diet and physical activity self-efficacy, self-esteem, general resilience, optimism, and HRQoL in the above groups. 3. To compare the differences in the groups between factors contributing to obesity (dietary behavior and physical activity), resilience (diet and physical activity self-efficacy, self-esteem, general resilience, and optimism), and HRQoL in Indian adolescents Main research question: Is there a relationship between resilience (measured as diet and physical activity self-efficacy, self-esteem, general resilience, and optimism) and BMI Z score in 14 - 16 years old school children from Kolkata? To answer this, the following sub-questions will be studied: 1. Is there a difference in resilience between the different groups of children (underweight, normal, overweight and obese)? To investigate this question, the level of diet and physical exercise self-efficacy, self-esteem, general resilience, and optimism will be investigated among overweight, obese, underweight, and normal-weight adolescents while controlling for age, gender, and type of school. 2. Is there a relationship between HRQoL and BMI Z score in different groups of children (underweight, normal, overweight and obese)? To investigate this question, the level of HRQoL will be investigated among overweight, obese, underweight, and normal-weight adolescents while controlling for age, gender, and type of school. 3. Is there a relationship between resilience and dietary behavior and physical activity in different groups of children (underweight, normal, overweight and obese) controlling for age, gender, socio-economic status and type of school? 4. Is there a relationship between parents' nutrition knowledge and resilience in children? To investigate this question, the level of parents' nutrition knowledge will be investigated among underweight, normal, overweight and obese adolescents while controlling for age, gender, and type of school.