Treatment Trials

567 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
The Clinical Impact of Integrated Behavioral Health Techniques in Patients With Fibromyalgia
Description

The purpose of this research is to assess the impact of using Lin Health to provide virtual long-term follow up care for patients with a diagnosis of fibromyalgia.

Conditions
ENROLLING_BY_INVITATION
Predict the Best Level of Care Placement for Each Child's Behavioral Health Needs - Effectiveness Study
Description

The purpose of this study is to test the effectiveness of a new clinical decision support tool, Placement Success Predictor (PSP), in a naturalistic setting. PSP will provide placement-specific predictions about the likelihood of a youth having a good outcome in each placement type at a behavioral health center using machine learning algorithms. The primary hypothesis is that clients in at least one placement within one standard deviation of the placement with the highest predicted likelihood of success will have better outcomes than the clients who were not. The secondary hypothesis is that clients' level of improvement over time will be positively correlated with the number of days they are in at least one placement within one standard deviation of the placement with the highest predicted likelihood of success.

ENROLLING_BY_INVITATION
Predict the Best Level of Care Placement for Each Child's Behavioral Health Needs - Efficacy Study
Description

The purpose of this randomized clinical trial is to test the efficacy of a new clinical decision support tool, Placement Success Predictor (PSP). PSP will provide placement-specific predictions about the likelihood of a youth having a good outcome in each placement type using machine learning algorithms. The primary hypothesis is that if clinical team members have access to PSP results for youth in the experimental group, these youth will have better outcomes at the 3-month follow-up compared to youth in the control group.

RECRUITING
Web-administered STAIR for Patients on Behavioral Health Waitlists
Description

Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services. Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medical Center (BMC) users (patients and providers) in a previous pilot study in primary care. The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic.

NOT_YET_RECRUITING
Warrior CARE: Cannabis Behavioral Health
Description

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

RECRUITING
Increasing Access to Evidence-Based Care in Integrated Behavioral Health
Description

The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future.

Conditions
RECRUITING
Adolescent Screening and Personalized Intervention Resource for Enhancement of Behavioral Health and Substance Use
Description

Only a small fraction of youth who are beginning to experience behavioral health problems and use alcohol or illicit drugs receive needed treatment services due to the lack of accessible, effective early intervention resources. The goal of this clinical trial is to compare a personalized brief web-based early intervention, eHealth Personalized Approach for Change Efficacy (ePACE), in which youth are offered choices regarding intervention content and desired level of engagement, to a "fixed", non-tailored brief intervention, eHealth Fixed Approach for Change Efficacy (eFACE) for adolescents with mild/moderate substance use and common co-occurring problems. Both ePACE and eFACE include a multi-problem screener that guides youths through a set of key integrated behavior change and counseling modules providing a cohesive focus on these four problem domains: drug abuse, interpersonal relations, negative emotions and stress. The main questions the trial aims to answer are: * Are substance use and co-occurring problem outcomes for ePACE and eFACE are superior to those for a waitlist comparison group (WC) * Are outcomes for ePACE are superior to those for eFACE * Are the direct effects of ePACE and eFACE (i.e., the improvements in substance use and co-occurring problem outcomes) associated with improvements in areas of functioning and new skills that are hypothesized to produce change -- that is, are the improvements shown in the ePACE and eFACE groups due to the mechanisms by which change is hypothesized to occur Participants in ePACE and eFACE will complete a baseline assessment prior to engaging in the intervention to which they are assigned and will complete post-intervention assessments 3 months and 6 months later. Participants in the WC group will complete three assessments: at baseline, 3-months, and 6-months.

NOT_YET_RECRUITING
Overdose Prevention Centers and Behavioral Health
Description

The aims of this study are: (Aim 1) Identify sources of heterogeneous impacts of opioid prevention center (OPC) use on non-fatal and fatal overdose risk among individuals with histories of polysubstance use (PSU); (Aim 2) Estimate the impact of OPC use on treated psychiatric events among clients with histories of PSU, and; (Aim 3) Assess the barriers and facilitators of integrating mental health services into existing syringe service and OPC delivery models.

Conditions
ACTIVE_NOT_RECRUITING
Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0
Description

This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). The investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align BHIP teams' care practices more closely with the principles of the CCM.

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

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.

NOT_YET_RECRUITING
Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy
Description

This is a single center non-randomized, single-arm feasibility trial of the implementation of virtual behavioral health counseling sessions alongside standard-of-care treatment.

Conditions
RECRUITING
Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children
Description

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.

ENROLLING_BY_INVITATION
BEhavioral Health Stratified Treatment (BEST) Study for Youth With Intellectual and/or Developmental Disabilities (IDD)
Description

Many youth with disabilities and their families receive "care coordination services" from a state Maternal and Child Health Bureau (MCHB) agency. MCHB care coordination services help youth with disabilities get the medical care and social services they need to be healthy. Complex HEalth Care for Kids (CHECK) developed a program to combine mental health treatment and care coordination services for youth with disabilities. The goal of this study is to see whether a care coordination program that treats depression and anxiety (MCHB care coordination + CHECK) is better than a care coordination program (MCHB care coordination alone) that refers youth to mental health services in terms of making youth feel healthier, happier, and able to handle future challenges. The project team will test which care coordination approach is better at making youth with disabilities: (Aim 1) less anxious and depressed; (Aim 2) feel healthier, function better, and practice healthy habits; (Aim 3) improve their ability to manage their health. This study will also evaluate which approach makes (Aim 4) youth, caregivers, and providers feel more satisfied with their care coordination experience. This study will give youth with disabilities and their families information about what kinds of care coordination models are available, and better suited to their needs. The study team will reach out to 780 youth with intellectual and/or developmental disabilities, age 13-20 years old, who receive care coordination services from the state of Illinois MCHB. If these youth are eligible and agree to be in the study, they will be placed, by chance, into either MCHB care coordination alone or into the MCHB care coordination + CHECK program. In both groups, youth will have a care coordinator who helps them identify and make plans to meet their needs and provides referrals to services/resources. Youth in the MCHB care coordination + CHECK care coordination will get mental health treatment directly from CHECK staff if they report symptoms of depression or anxiety. Treatment may include an online program or group meetings that teach youth how to cope with negative thoughts and feelings. Youth in each group will be followed for 24 months and will receive gift cards for participating. Youth will be asked questions about anxiety and depression, health, functioning, ability to manage their health care, self-efficacy, and their experience with care coordination.

RECRUITING
Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health
Description

The purpose of this 2-arm randomized controlled trial is to assess the efficacy of a 10-session lesbian, gay, bisexual, transgender, and queer (LGBTQ)-affirmative cognitive-behavioral psychotherapy (CBT) delivered via telehealth in a large sample of sexual minority women (SMW) in New York, New Jersey and Pennsylvania. The investigators will assess whether the EQuIP (Empowering Queer Identities in Psychotherapy) treatment demonstrates significant reductions in heavy drinking (HD) and mental health symptoms (e.g., depression) compared to LGBTQ-affirmative treatment-as-usual.

COMPLETED
An Evaluation of Virtual Psychiatric Transition of Care Offered in Behavioral Health
Description

The primary objective is to evaluate the effectiveness of a post inpatient discharge virtual psychiatric care team compared to standard care, to reduce 30-day all cause non-elective acute care utilization (Emergency Department (ED), observation, and inpatient encounters).

RECRUITING
The DC Mother-Infant Behavioral Wellness Program
Description

This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.

COMPLETED
Study to Compare the Use of a Behavioral Health App Versus Care As Usual for 16-22 Year Olds with Depression
Description

Randomized Controlled Trial comparing a coach-enhanced digital cognitive behavioral intervention (d-CBI) (RxWell) + treatment as usual (TAU) versus TAU alone for moderate depression as determined by Patient Health Questionnaire (PHQ-9) threshold as part of routine pediatric care. The study will be completed in pediatric practices with embedded behavioral therapists across 3 institutions (Children's Hospital of Pittsburgh, Boston Children's Hospital, Rady Children's Hospital, San Diego).

Conditions
COMPLETED
A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients
Description

The purpose of this study is to determine how to incorporate a smart water bottle to improve bladder filling for prostate cancer patients undergoing radiation therapy.

COMPLETED
A Feasibility Study for Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings and Its Impact on Adolescent Mental and Behavioral Health
Description

This research study examines rural youth's experience of an internet based cognitive behavioral therapy intervention, and their experience of symptoms of depression, anxiety and co-occurring disorders.

COMPLETED
Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants
Description

The purpose of the study is to evaluate the acceptability and preliminary efficacy of a universal prevention program delivered by psychologists in conjunction with pediatric primary care well-child visits.

Conditions
RECRUITING
Chronic Pain Management In Primary Care Using Behavioral Health Consultants
Description

The purpose of this randomized pragmatic trial is to assess the effect of monthly booster contacts on long-term Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) pain outcomes compared to BCBT-CP without a booster in 716 Military Health Systems (MHS) beneficiaries referred to a Behavioral Health Consultant (BHC) for pain management using BCBT-CP. Patients will be randomly assigned to receive either standard BCBT-CP (working with a BHC in the medical home clinic) or standard BCBT-CP with adjunctive monthly booster contacts. Additionally, patient participants and clinic providers and staff will be offered the opportunity to participate in separate post-treatment Focus Groups using a semi-structured interview format designed to assess the usability, ease of use, perceived effectiveness, helpfulness, and barriers to the pain management intervention. Patient participants will be assessed 3-, 6-, 12- and 18-Months following their first appointment for BCBT-CP. Prospective data will be supplemented by a national data pull in collaboration with the Defense Health Agency and the Uniformed Services University Center for Rehabilitation Sciences Research. Pulled data will include a national deidentified dataset of electronic health record data for all individuals treated in the military health system who had access to a Behavioral Health Consultant for the treatment under study in this trial.

Conditions
COMPLETED
Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health
Description

This project aims to enhance AN university students' behavioral health by supporting their cultural identity development. While the connection between cultural identity and behavioral health is becoming clearer, comparably less research has explored methods of enhancing identity development. Consequently, the investigators will pilot a cultural identity development program for AN students at the University of Alaska Anchorage (UAA). This intervention is based on extant scientific literature, local findings from focus group with AN students, and traditional wisdom from AN Elders. The eight-week Elder-facilitated program incorporates storytelling, experiential learning, connection, exploration, and sharing of identity, cultural strengths, life paths, and rootedness in who they are in order to remain grounded when they face changes and challenges. Approximately 40 to 50 AN university students will be recruited for the intervention. Participants will be randomized, with half the participants receiving the intervention in the Fall 2020 semester and half the students receiving the intervention in the Spring 2021 semester. We hypothesize that engaging in this intervention will strengthen AN students' cultural identities, strengths, and sense of community; improve their behavioral health, as evidenced in higher self-reported wellbeing, and lower substance use, depression, anxiety, and suicidal ideation symptoms; and support their academic persistence and achievement. Outcomes will be tested via mixed design analyses of covariance. Moreover, program feasibility will be examined through a process evaluation, which will entail thematic analyses of six focus groups with program participants (n=40-50) and with the Elders who facilitated the program (n=5).

UNKNOWN
Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders
Description

The aim of this pilot intervention is to examine the acceptability of a harm reduction intervention approach to tobacco use for individuals with serious behavioral health disorders and its association with a decrease in smoking. The intervention uses a "dynamic" approach to patient choice, allowing participants the option to explore different strategies for harm reduction, while providing support from counselors in the process. Therefore, the investigators have chosen an observational study design in order to document and explore the acceptability and outcomes of the intervention.

Conditions
ACTIVE_NOT_RECRUITING
Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care
Description

This study will give researchers the opportunity to evaluate implementation of the Collaborative Behavioral Health Program (CBHP), based on the collaborative care model for depression, which aims to improve practice for physicians and staff; improve care for patients; and improve clinic operations through a model that allows for more efficient identification and referral for care for depression.

Conditions
COMPLETED
A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments
Description

This research project is a pragmatic, randomized evaluation of a quality improvement initiative which seeks to evaluate the effects of standardizing the use of a BH-VPN program among patients with a telepsychiatric consult. The outcomes evaluation of this intervention has been designed to integrate with routine care and minimize frontline staff burden by deploying an evaluation in a real-world setting.

RECRUITING
Navigating Resource-Constrained Systems and Communities to Promote the Behavioral Health of Black Youth
Description

This study aims to reduce racial disparities in child mental health care by examining the impact of a child behavioral health navigator (cbhNs) intervention in which cbhNs (n=15) will be trained to deliver an evidence-based family engagement, psychoeducation and support intervention to 390 early adolescent youth (10 to 14 years) and their families of African descent living in geographically defined St. Louis north city and county neighborhoods.

COMPLETED
Virtual Behavioral Health Integration
Description

The primary objective is to evaluate the effectiveness of the virtual behavioral health integration (VBHI) program compared to usual care, on reducing the total cost of care reimbursed from Medicare and value-based contracts within 90 days of a patient's primary care visit.

ACTIVE_NOT_RECRUITING
Reducing Disparities in Behavioral Health Treatment for Children in Primary Care
Description

The purpose of this study is to address a decisional dilemma faced by health system officials, policy makers, and clinical leaders: "Does it make sense to integrate behavior therapy into primary care practice to treat children with ADHD from low-income settings? More specifically, does integrated care improve access to services and patient-centered outcomes for underserved children with ADHD?" Participants will be randomly assigned to one of two groups: Behavior therapy integrated into primary care (Partnering to Achieve School Success; PASS program) to treatment as usual (TAU) informed by American Academy of Pediatrics (AAP) guidelines for ADHD practice and facilitated by electronic practice supports." Participants will be 300 children (ages 5-11) with ADHD and their caregivers served at Children's Hospital of Philadelphia Care Network Locations (primary care offices). Participants are drawn from primary care locations that serve primarily low-income and racial/ethnic minority population.

Conditions
ACTIVE_NOT_RECRUITING
Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
Description

A comparative effectiveness study using an individual-level randomized design along with a pragmatic, mixed-methods approach to compare two strategies (e.g. in-person supported care, technology-supported care) all of which include evidence-based components for delivering IBD and BH care. Quantitative (e.g. self-report, electronic health record, process) and qualitative (e.g., interviews) data will be collected across multiple time points during the study period.

COMPLETED
Telesimulation and Behavioral Health
Description

This study proposes to assess attitudes, perceived proficiency, and knowledge related to telemedicine by implementing telesimulation behavioral health scenarios in a cohort of healthcare students using the Contextual Interview Observation Form.

Conditions