Clinical Research Directory

A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans

Risk of Veteran suicide is elevated during the first year of transition from military service to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA healthcare. Suicide prevention and connection to care are therefore critical for recently transitioning Veterans. Transitioning Veterans require services to provide them with suicide prevention education, skills to manage their transition effectively, and support in their access to VA healthcare. Convenient, accessible, palatable, patient-centered care options that are cost-effective, easy to implement nationwide, and target domains known to mitigate suicide risk are needed during this critical transition period. This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education, skills to improve transition, support to access VA care, and a platform to decrease social isolation early in their military to civilian transition, thereby reducing suicide risk downstream.

Step-by-Step: Evaluation of a Stepped Care Model

The primary aim of this project is to examine the effectiveness of a stepped care model of interventions for children's defiant or aggressive behavior problems. The stepped model consists of a brief internet-based parenting support program (Step 1). For those with continued need of additional interventions, Step 2 includes access to one of following interventions: b) a Cognitive Behavior Therapy (CBT) -Virtual Reality (VR)-assisted parenting support program, b) a Cognitive Behavior Therapy -Virtual Reality-assisted child intervention, or c) standard interventions/support at the family's unit/clinic and continued access to the study's internet-based parenting support program, after which the family may choose CBT-VR for the child or the parent.

Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms

Art therapy is used across the Military Health System for treatment of posttraumatic symptoms, but there is limited research on how art therapy is able to restore emotional expression and regulation in service members. This research hopes to learn about the effects of art therapy on emotional expression and regulation in service members as well as the neurological systems at work. If a participant chooses to be in this study, he or she will attend eleven sessions over a period of six to eight months. The first session will be an interview and self-assessment questionnaires to collect information on a variety of symptoms, experiences, and personality traits, and an MRI scan. During the MRI scan, participants will be asked to perform a task where they will be shown a series of neutral and negative images. The following eight sessions will be one-hour art therapy sessions with a certified art therapist. The tenth session will consist of the same self-assessment questionnaires and another MRI scan. The final session will consist of some of the same questionnaires from the tenth visit, as well as a qualitative interview done virtually three months after the tenth visit.

Parent Management Training to Treat Irritability

The goal of this clinical trial is to see if 12 sessions of a Parent Management Training program can treat irritability in children aged 10-14 years old. The main question it aims to answer are: * Can a Parent Management Training for parents reduce anger outbursts and cranky moods in their children? * Can Parent Management Training be done in an outpatient clinic and do parents like it? Up to 18 families can join this study. This study will be used to set up a larger study in the Fall of 2025. Parent participants will complete 12 sessions of Parent Management Training for Irritability. Each session will be 45-55 minutes weekly. They will also participate in the assessments of their child before, during and after treatment. Child participants will do assessments before, during and after the Parent Management Training treatment.

Mobile Anger Reduction Intervention

Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). Problematic anger is associated with significant functional impairment. In the current project, the investigators will compare the Mobile Anger Reduction Intervention (MARI) with a health education mobile intervention (HED) among Veterans with PTSD and problematic anger. Participants will be randomized to the MARI or HED condition. The hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.

Behavior Therapy for Irritability in Autism

This is a clinical trial of a novel intervention, Behavioral Therapy for Irritability and Aggression (BTIA), for adolescents on the autism spectrum. The main goals of BTIA are to help adolescents develop emotion regulation skills to handle frustration and to strengthen skills for navigating the challenging and diverse experiences associated with the transition to adulthood. The study will test whether BTIA can be helpful to adolescents on the autism spectrum and to their families.

Building Emotional Awareness and Mental Health (BEAM) 2024-2027

Children are highly sensitive to adversity during their first five years of life, with exposure to chronic parental mental illness (MI) consistently linked to socio-emotional impairments and mental health problems in children. Children born during the COVID-19 pandemic were exposed to unprecedented level of parental distress, with parental MI reported at three times the pre-pandemic rates. This situation underscored a pressing need for scalable solutions to foster positive mental health and developmental outcomes for a generation of children. In response, the investigators developed the Building Emotional Awareness and Mental Health (BEAM) program, an innovative mobile health (mHealth) solution for parents of young children. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. This trial involves an effectiveness-implementation hybrid design with co-primary aims of (1) determining BEAM's effectiveness in improving child mental health and developmental outcomes, and (2) evaluating the implementation of BEAM in the community through metrics such as feasibility, acceptability, and uptake. The secondary aim of this trial is to measure BEAM's effectiveness in improving long-term biopsychosocial family outcomes using administrative data. A final exploratory aim of this trial will measure the cost-utility of delivering BEAM relative to extant health programming. This trial will evaluate the effectiveness of implementing the BEAM intervention in the community with a sample of 400 parent participants with a child aged 24-71 months. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app, with access to an online social support forum and check ins with a peer coach. Assessments of parent and child symptoms will occur at pre-test before BEAM begins (T1), immediately after the last week of the BEAM intervention (post-test, T2), 6-month follow-up (T3), and 12-month follow-up (T4). Beginning in 2025, the trial offers participants the option to invite one parenting partner to join them in the program. A parenting partner is defined as a co-parent (e.g., the child's mother, father, or step-parent) or another primary caregiver (e.g., a grandparent, cousin, uncle, or aunt). Each participant may invite one such individual, hereafter referred to as a "co-parent." Co-parents will have access to the BEAM intervention and all its features, with the exception of peer coaching. Co-parents will be eligible to complete the same outcome measures at the same timepoints as participants. Three differences that will separate co-parents from participants are: (1) co-parents will not be asked to complete the ASQ:2-SE or ASQ-3 secondary outcome measures; (2) co-parents will not have access to peer coaching, and (3) co-parents will not be required to be experiencing moderate to severe symptoms of depression, anxiety, parenting stress, and/or anger. (Please see Eligibility \> Eligibility Criteria for the less restrictive inclusion and exclusion criteria for co-parents.) Co-parents will not be counted toward the trial sample size of n=400, and will not be included in primary analyses. Instead, co-parent data will be used in sub-studies to address exploratory research questions. The BEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related child functioning concerns. The present implementation trial aims to extend the groundwork established by an open pilot trial and RCT of the BEAM program, in a next step of testing BEAM's readiness for nationwide scaling.

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.

Therapy Dog Visits for Patients Hospitalized With Traumatic Injuries

Animal assisted therapy (AAT) with dogs has been shown to be beneficial for a wide range of patients with both acute and chronic illnesses, including spinal cord injuries, heart failure, myocardial infarctions, strokes, cancer, post-traumatic stress disorder, and depression. Studies have also demonstrated that even in healthy adults, the presence of dogs is associated with physiologic changes such as increased pain threshold, decreased blood pressure, and decreased heart rate. However, few studies have investigated the role of AAT in the post-operative course in adults. This study will investigate the impact of therapy dog visits on pain and anxiety scores for trauma patients at Boston Medical Center (BMC).

Experiences of Anger in Patients in Primary Health Care With Symptoms of Generalized Anxiety

Symptoms of generalized anxiety is common in the general population and is often treated in primary health care. Anger is an emotion that can lead to interpersonal problems but can also be an agent for justice and change. Previous research has shown a link between generalized anxiety and anger but there is a lack of qualitative research investigating how individuals with symptoms of generalized anxiety experience anger. The aim of this research study is to increase knowledge about how anger is experienced in adult patients in primary health care with symptoms of generalized anxiety and about the experiences of health care professionals working with patients with symptoms of generalized anxiety.

The Efficacy of Lavender Herbal Tea in Misophonia

Misophonia is a disorder characterized by a high level of annoyance with certain sounds. Exposure to these sounds causes physical symptoms characterized by anger, aggression, helplessness, overwhelm, and stimulation of the sympathetic nervous system. These emotional and physical reactions can lead to a decline in family relationships, work and school productivity, withdrawal from social relationships, and even suicide. There is limited empirical evidence evaluating the efficacy of therapeutic approaches to misophonia. This limited empirical evidence consists of pharmacological agents such as selective serotonin reuptake inhibitors, stimulants, antipsychotics, and β-Blockers, as well as cognitive behavioral therapy, acceptance and commitment therapy, and dialectical behavior therapy. Complementary therapies are important because of their potential efficacy, tolerability, possible non-interference, and low cost. The fact that lavender has anxiolytic, antidepressant, neuroprotective, and anti-inflammatory properties may affect the emotional and physical responses elicited by misophonia. Therefore, within the scope of the study, misophonia individuals will be divided into two groups; one group will use lavender tea for 14 days and the other group will form a waiting list. The study data will be collected by 'Information Collection Form', 'Misophonia Scale', 'Beck Depression Inventory-II', 'Anxiety Rating Scale', and 'Trait Anger Scale'. SPSS 25.0 software will be used to analyze the data obtained from the research. Considering the limitations of therapeutic approaches for misophonia, testing the effectiveness of lavender in reducing misophonia symptoms will make an important contribution to the literature.

Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Behavior Problems

The main aim of this small pilot trial is to evaluate preliminary effects and feasibility of the child intervention YourSkills for child disruptive behavior (e.g., enhanced anger or aggressive behavior) when evaluated in Sweden for children/youth aged 10-16 years. YourSkills is based on cognitive behavioral therapy (CBT) and includes practicing of skills in virtual reality (VR). The main questions the project aims to answer are: * What are the preliminary effects of the child/youth CBT-VR-program? * What is the level of child/youth engagement in the CBT-VR program? * What are the experiences of parents, children/youth and therapists of the program? The CBT-VR program is delivered at clinics during ten individual sessions. Parents will answer quantitative measurements before and after treatment, children will answer quantitative measurements before, during and after treatment. Within- group analyses will be conducted to examine experiences and preliminary effects of the program. Parents, children and clinicians are also asked to participate in a qualitative interview after the program has ended.