Clinical Research Directory

The Effect of Laughter Therapy on Hemodialysis Patients

Internet-based behavioral therapy applications made during the quarantine and isolation period during the pandemic process, and the application of laughter therapy, which is a group-oriented technique that increases the feeling of togetherness and happiness, can be used as an online method to reach large masses. However, since there are a limited number of studies in the literature on online laughter therapy in patients and not all sessions are online in the study, it was thought that more and methodological studies are needed to confirm the effectiveness of the therapy on the applicability of the online platform. Therefore, this study was conducted to evaluate the blood cortisol levels, depression, anxiety, stress levels and quality of life of laughter therapy in hemodialysis patients.

Generative Artificial Intelligence Intervention and Individual Psychological Counseling on Emotional Distress in Young Adults

This randomized controlled trial aims to evaluate the effectiveness of an AI-based mental health chatbot, Emohaa, in reducing symptoms of depression, anxiety, insomnia, and academic burnout among young adults experiencing emotional distress. A total of 222 participants will be randomly assigned to one of three groups: (1) AI chatbot intervention, (2) traditional counseling, or (3) waitlist control. The study spans six time points from baseline through one-month follow-up. Primary and secondary outcomes will be measured via validated self-report questionnaires. The intervention is delivered entirely online through a WeChat-integrated platform, ensuring high accessibility and scalability.

Advancing Family Wellbeing Through a Massive Open Online Intervention: The LightBEAM Program

Early childhood is a critical period for developmental outcomes, and the parent-child relationship plays a vital role in shaping cognitive and social development. However, elevated parental distress (e.g., depression, anxiety, anger) can disrupt healthy relationships, increasing the risk of negative child outcomes such as difficult temperaments, altered cognitive development, and socio-emotional challenges. Despite the well-documented effects of untreated parental distress, Canadian families face significant barriers to accessing timely and effective mental health support. To address this gap, our team developed BEAM, an app-based program that provides parenting and mental health resources. BEAM includes expert-led videos, online forums, progress monitoring, and peer-coaching sessions. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. Building on BEAM's success, we have developed the LightBEAM program, which aims to expand these supports into a scalable, accessible, massive online open intervention (MOOI) to reach a larger number of families across Canada, particularly in underserved areas or those on waitlists for individualized services. LightBEAM has the potential to support parental mental health, fostering healthier child and family development while addressing barriers to traditional mental health care. This trial involves a pre-post randomized trial design with primary aims of (1) assessing feasibility and acceptability metrics of LightBEAM including recruitment/retention, sustainability, satisfaction, and unmet needs, (2) examining the efficacy of LightBEAM versus waitlist control at improving family and mental health outcomes, and (3) determine for whom LightBEAM is more or less effective at engaging with and addressing mental health needs. This trial will evaluate the feasibility and effectiveness of LightBEAM with a sample of up to 300 parent participants with a child aged 18-107 months. Co-parents of parent participants are permitted to participate in the study as well but are not included in this sample of 300 parent participants. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app. The LightBEAM program will consist of four different components; weekly parenting and mental health videos, weekly progress tracking, a group forum, and exercises designed to reinforce skills learned through the video content. Assessments of parent and child symptoms will occur at pre-test before LightBEAM begins (T1), immediately after the last week of the LightBEAM intervention (post-test, T2), and 6-month follow-up (T3). The LightBEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related metrics of child well-being. By adapting BEAM, an evidence-based parenting and mental health app, into LightBEAM, a large-scale online intervention, the present trial aims to provide accessible mental health support for Canadian families. LightBEAM could reach families in remote areas with limited services, offer interim support during waitlists, or function as a self-referral program.

Test of Target Engagement of Ambiguity Aversion

The present work aims to test whether a single session intervention alters ambiguity aversion, both in terms of people's decision making and their brain responses to ambiguous choices.

Harlem Strong Mental Health Coalition

Addressing health disparities, especially in the face of coronavirus pandemic, requires an integrated multi-sector equity-focused, community-based approach. This study will examine the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works with a network of community-based organizations, medical providers, and behavioral health providers to engage in a network-wide implementation planning process to: (1) problem-solve financing, access, and quality of care barriers, (2) support capacity building for mental health (MH) task-sharing for community health workers, (3) facilitate coordination and collaboration across MH/behavioral health, primary care, and a range of social services, including case management, housing supports, financial education, employment support, and other community resources to improve linkages to services, and (4) identify a set of common MH, social risk, and health metrics and strategies to integrate these metrics into data systems across the network for continuous quality improvement of the system. The long-term goal of our study is to develop sustainable model for task-sharing MH care that will be embedded in a coordinated comprehensive network of services, including primary care, behavioral/MH, social services, and other community resources.

Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Patients

Investigators will evaluate the implementation of an evidence-based, Spanish-language, digital, cognitive-behavioral therapy intervention (SilverCloud) in primary care settings for Latino patients with depression and/or anxiety. 426 participants will be enrolled in a two-armed trial comparing self-guided vs. supported dCBT (SilverCloud). At the provider level, investigators will compare the efficacy of provider referrals with the use of a clinic patient registry to identify candidates who could benefit from a digital mental health intervention.

The COMParing App Support Strategies Study

The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.

Psychobiological Interventions in Pregnancy

This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation.

Prevention of Psychological Health Problems Via Integrated Operational Support

Sub-clinical behavioral health services in the military are performed by BH technicians, who receive minimal training. Due to this, embedding more technicians in military units is unlikely to benefit service members. Giving technicians training in, and access to, evidence-based interventions (EBI) could make their work more effective. The proposed study is a training trial examining the efficacy of the full integrated operational support (IOS) toolkit (evidence-based interventions for behavioral health), relative to routine care using standard resources, as a prevention resource for active-duty airmen.

Youth Emotional and Behavioral Treatment Study

This study aims to characterize key mechanisms underlying the development, maintenance, and treatment of severe irritability in a clinically heterogeneous sample of school-aged youth.

Early Psychological Intervention After Rape

Rape is a common cause of post-traumatic stress disorder (PTSD) among women, as around 30-50% will develop PTSD in the aftermath of rape. A modified protocol based on Prolonged Exposure Therapy (mPE), has been developed, consisting of three to five once or twice weekly 60 minutes sessions, and studies indicate that if implemented early after rape, mPE may prevent the development of PTSD. The aim of the study is to conduct a multi-site (4 Sexual assault care centers in Norway) randomized control trial (RCT) in which patients are recruited early after rape, and randomized to intervention (mPE) or treatment as usual (TAU).

A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID

For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic. The investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems. Aim 1: Conduct interviews of URM and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources. Aim 2: Through a randomized controlled trial (RCT) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by Cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of COVID.

Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.

Acceptance and Commitment Therapy for Adolescents and Young Adults With Sickle Cell Disease

The current study seeks to build on previous research that demonstrates the efficacy of Acceptance and Commitment Therapy in combating stigma by investigating the feasibility and acceptability of a protocol to support Black adolescents and young adults in coping with race related stress. The study will consist of a small, purposeful, non-randomized sample (N = 30) of clients enrolled into a 10-session Acceptance and Commitment Therapy group. The group will be offered as part of regular clinical care at the Division of Adolescent and Young Adult Medicine. Three consecutive groups will be run with approximately 8-10 participants in each group over the next year.

Modulating Exercise Dosage to Improve Concussion Recovery

Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.

Multidimensional Sleep Health Intervention to Optimize Concussion Recovery

Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.

Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention for Middle-Aged and Older Adults With Chronic Pain

The purpose of this research study is to refine customized in-app notifications in order to optimize users' experience with a mobile app called Wysa for Chronic Pain. This app is designed to support people who have chronic pain and who also experience symptoms of depression and/or anxiety. This version of the app is not currently available to the public. Eligible participants will be asked to download and use the Wysa for Chronic Pain study app for several weeks, and to use it as they normally would if they were not part of a research study. At the beginning and end of the study period, participants will be asked to complete brief surveys about their mood, pain, physical function, and sleep. Additionally, a few participants will be asked to share their experience with the study app at the end of the research study in a casual interview using a secure audio/video recorded call. Participating in the interview portion is optional.

Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons

The goal of this research study is to adapt an ACT-self-help workbook to the prison setting and determine the feasibility acceptability, and effectiveness of this workbook. Participants can expect to be in the study for 13 weeks.

Youth Depression and Suicide Research Network

The objective of this study is to build the Texas Youth Depression and Suicide Research Network to support the development of a Network Participant Registry and characterization of systems and interventions to examine statewide population health outcomes. All 12-13 sites represented in the Texas Child Mental Health Care Consortium (https://www.utsystem.edu/pophealth/tcmhcc/) have been invited to participate in the Texas Youth Depression and Suicide Research Network as "Nodes." 12 Nodes have been selected for this project. Each Node has obtained support of senior institutional leadership including the department chair. Leadership from each Node provided input and edits in the study design process by committee, with a focus on the inclusion of the "end user" in design decisions. Nodes will work closely with the Network Hub leadership to recruit, monitor, and retain participants. This will require active engagement and sustained relationships with clinics within the academic medical center as well as clinics in the community (i.e., psychiatry, psychology, counselling).

Online Intervention for Transgender/Nonbinary Young Adults' Experiences With Alcohol and Romantic Relationships

The objective of this study is to learn more about Whole Selves, an interactive online resource ("intervention") to help transgender and/or nonbinary young adults reflect on their experiences and goals related to both alcohol use and romantic relationships. Existing online interventions focused on alcohol use often aren't a good fit for trans/nonbinary people, and existing relationship education programs don't account for how being trans/nonbinary might influence someone's relationships. For these reasons, the investigator is working with trans/nonbinary young adults and other community stakeholders to create a new intervention specifically for trans/nonbinary young adults. The goals of this clinical trial are to: 1. Find out what transgender/nonbinary young adults think of the Whole Selves intervention in order to improve it 2. See whether the Whole Selves intervention seems to work as expected 3. Help the investigator make plans for a bigger clinical trial of the Whole Selves intervention, which could tell us how well it works In this study, participants will use the Whole Selves intervention; complete online surveys about themselves, their romantic relationship experiences, their mental health, their alcohol use; and provide feedback on the Whole Selves intervention.

Weekly Dynamics of Psychopathological and Symptom Networks During Mindfulness-Based Interventions for Emotional Distress

The goal of this clinical study is to learn how Mindfulness Intervention for Emotional Distress (MIED) helps people with emotional distress and how their symptoms and psychological patterns change over time. The main questions it aims to answer are: * How do the relationships between emotions, thoughts, and behaviors change week by week during mindfulness training? * Which psychological skills, such as distress tolerance or cognitive flexibility, improve first and lead to later emotional relief? Two groups will be compared - one that takes part in an online mindfulness intervention and one that waits to join - to see how the intervention changes emotional and psychological networks over time. Participants will: * Complete a 7-week online self-guided Mindfulness Intervention for Emotional Distress（iMIED） designed for people experiencing high emotional distress. * Fill out short weekly questionnaires about their emotions, thoughts, and behaviors before, during, and after the course (9 times in total). * Receive access to the mindfulness program after the study if they are in the wait-list group. This study includes about 500 adults aged 18 and older who feel anxious, depressed, or emotionally distressed but have no major psychiatric disorders. By tracking weekly changes, the research aims to identify how mindfulness intervention leads to emotional improvement and which skills play the most important roles in that process.

PRISM for Depression and Anxiety in Young Adults With Cancer

This research study is being done to test the feasibility of an existing supportive program (PRISM) to address psychological symptoms (i.e., depressive and anxiety symptoms) that young adult participants diagnosed with cancer or desmoid tumor may experience. The name of the intervention used in this research study is: -Promoting Resilience in Stress Management (PRISM) Program

Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda

This study record describes a two-phase of clinical trial study. The first phase is a pilot study phase (to study feasibility and efficacy of the intervention), and the second phase is an effectiveness study phase (a fully powered evaluation study to test the intervention effectiveness). This proposal seeks to develop and test a new mHealth intervention, the mHealth Toolkit for Wellness \& Empowering Lives of School Community (mWEL) in Uganda. The mWEL-digial toolkit is a preventive intervention tool for teachers and parents as a self-help support modality. Caregivers who need support in navigating the toolkit will be supported by peer-community health workers (P-CHWs).

Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.