37 Clinical Trials for Various Conditions
The purpose of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illness (SMI).
The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are: * Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation? * Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation? * Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes? Participants will: * Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training. * Complete a questionnaire prior to the workshop. * Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy. Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms.
The goal of this study is to examine the effectiveness of a brief, episodic future thinking (EFT) intervention in a substance use treatment setting serving returning citizens with substance use disorders (SUD). The main questions it aims to answer are: 1. Determine preliminary implementation potential of the EFT intervention, including acceptability and feasibility of conducting the intervention. 2. Examine the preliminary effectiveness of this approach, with a specific focus on patient outcomes, including changes in delay discounting, treatment retention, treatment motivation, and substance use. Participants will be asked to participant in pre and post assessment questionnaires, participate in a single-episode brief intervention followed by tailored phone call follow-ups.
Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minority individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT), we will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over six months.
This study will evaluate the impact of a program (called mind. body. voice. or "mbv") that was collaboratively designed by youth, educators, and researchers, informed by the Body Project (Becker et al., 2013; Stice et al., 2019), Youth Participatory Action Research, an extended co-design process, and previous iterations of the mbv program. The study evaluates the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self-constructs, physical health and mood at three time points over the course of the 10-week program, which will be offered remotely in response to the COVID-19 pandemic. Students will be recruited from high schools and will be randomized to receive the mbv program or an assessment-only control group.
This study will evaluate the impact of a program (called mind. body. voice. or "mbv") that was collaboratively designed by youth, educators, and researchers, informed by the Body Project (Becker et al., 2013; Stice et al., 2019), Youth Participatory Action Research, and an extended co-design process. The study evaluates the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self-constructs, physical health and mood at five time points over the course of a year. Students will be recruited from two high schools and will be randomized to receive the mbv program or an assessment-only control group.
This study will test whether a peer-delivered intervention for high school students with ADHD outperforms enhanced school services as usual. Ninth grade students with ADHD (N=72) will be randomly assigned to the intervention (summer STRIPES) or the enhanced school services control group (SSU plus). Students will be assessed in the spring of 8th grade, fall of ninth grade, and spring of ninth grade. Primary outcomes will be GPA, Class Attendance, Disciplinary Incidents, and ADHD symptoms (parent and teacher report).
Adults with serious mental illness (SMI) are disproportionately affected by medical comorbidity, earlier onset of disease, and 10 to 25 years reduced life expectancy compared to the general population. These high rates of morbidity and early mortality are associated with inadequately managed medical and psychiatric illnesses. A recent systematic review found nine effective self-management interventions that address medical and psychiatric illnesses in adults with SMI. However, there has been limited adoption of these interventions due to both provider and consumer-based factors. Provider-based barriers consist of the lack of an adequate workforce with the capacity, time, and knowledge of effective approaches to self-management support for adults with SMI and chronic health conditions. Consumer-based barriers associated with limited participation in self-management programs include lack of access, engagement, and ongoing community-based support for persons with SMI. Peer support specialists have the potential to address these barriers as they comprise one of the fastest growing sectors of the mental health workforce, have "lived experience" in self-management practices, and offer access to support in the community. However, challenges need to be resolved for peers to be effective providers of evidence-based interventions. For example, peers are frequently trained to provide "peer support" described as "giving and receiving help founded on key principles of respect, shared responsibility, and mutual agreement of what is helpful". Peer support has been associated with increased sense of control, ability to make changes, and decreased psychiatric symptoms. Despite benefits, peer support does not adhere to evidence-based practices for psychiatric and medical self-management and does not follow protocols that ensure fidelity and systematically monitor outcomes. The investigators hypothesize that mobile technology has the potential to overcome these limitations of peer support by providing real-time guidance in fidelity adherent delivery of a peer-delivered, technology-assisted evidence-based self-management intervention (PDTA-IIMR). The investigator will build the necessary expertise to pursue a career developing and testing novel approaches to peer-delivered evidence-based self-management interventions. Training will include: development of peer-delivered interventions; development and design of mobile health-supported interventions; and intervention clinical trials research. Concurrently, this study includes refinement of the intervention protocol with input from peers and consumers and conducting a pilot study evaluating the feasibility and potential effectiveness of PDTA-IIMR compared to routine peer support for N=6 peers and N=40 adults with SMI and chronic health conditions. Outcomes include feasibility, medical and psychiatric self-management skills, functional ability, and mortality risk factors and examine self-efficacy and social support as mechanisms on outcomes.
This study will evaluate the impact of the Body Project (a dissonance-based program designed to address body image concerns and prevent eating disorders) on key eating disorder risk factors and relevant social and self-constructs at three time-points (pre, post, and one-year follow-up). Young women will be recruited from two high schools and will be randomized to receive the Body Project or to the control group. The Body Project will be facilitated by college-aged women.
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minoritized individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this pilot trial, the investigators will evaluate the feasibility, acceptability, and fidelity of this approach (implementation outcomes) and preliminary effectiveness on methadone treatment retention at three months.
Safety planning is a brief, ED-feasible intervention which has been demonstrated to save lives, and has been universally recommended by every recent expert consensus panel on suicide prevention strategies. In one popular version of the safety plan developed by Stanley et al, the patient is encouraged to write out the following items: identifying personal signs of a crisis; helpful internal coping strategies; social contacts or settings which may distract from a crisis; using family members or friends for help when in crisis; mental health professionals who can be contacted when in crisis; and restricting access to lethal means. In most emergency departments, safety-planning is done by clinical personnel such as psychologists or social workers, but these providers are often too busy to perform safety-planning well or have multiple other patient care responsibilities. This study aims to find out if ED patients prefer to complete a safety plan with a peer supporter or clinical personnel. People who are visiting the emergency department for thoughts of self-harm will be asked to participate.
The purpose of this study is to 1) convene African American and Latino Community Coalitions to adapt Family Teamwork (FT) for school-age youth, and integrate FT with the Smart and Secure Children (SSC) program community-based, peer delivery format, 2) identify facilitators and barriers to parental involvement in diabetes management for African American and Latino parents of children (5-9 years) with T1D to refine, with Community Coalitions the adapted and integrated Family Teamwork- Peer Delivery (FT-P), and 3) evaluate the feasibility, satisfaction, and preliminary outcomes of the FT-P program among African American and Latino parents of school-aged children (5-9 years) withT1D. A randomized pilot trials will be conducted with African American and Latino families to examine the feasibility, parent satisfaction, and preliminary outcomes of FT-P. Families will be stratified by race/ethnicity, age, and HbA1c strata, and randomized to FT-P plus standard diabetes care or to standard diabetes care alone after completion of baseline assessment using a random numbers table generated by a program created through Baylor College of Medicine's Institute for Clinical Training and Research data management specialists.
The investigators are evaluating a service called peer-delivered Whole Health Coaching to understand how it can help Veterans with PTSD. This project has two main goals: (1) determine how peer-delivered Whole Health Coaching can help Veterans with post-traumatic stress disorder and (2) learning about feasibility of implementing this service in Veterans Health Administration primary care settings. The investigators are also evaluating feasibility of the research methods in this trial to learn how to improve future studies on this topic. Whole Health Coaching is a service designed to improve health and wellness. It is a variation of integrative health coaching and is being used in Veterans Health Administration medical centers. In Whole Health Coaching, Veterans will work with coaches to develop a personal health mission, develop specific goals and action steps, and then adjust their plan as needed. Coaches provide guidance and support throughout the process. In this project, a peer support specialist working in primary care will be the coach. VA Peer Support Specialists, "peers", are Veterans recovering from a mental health condition trained to help other Veterans improve their health. All participants will receive peer-delivered Whole Health Coaching. Participants will be randomly assigned a start date for their first session with the Peer Whole Health Coach between 4 and 13 weeks after they start the study. The information provided during this time prior to the first session helps us understand how participants do on their own without the service. The research components include interviews and questionnaires about health and wellness, goals, and experiences with the service. Veterans who participate in the study will complete short questionnaires twice a week for 6 months and have four longer appointments where more questions will be asked. Participants will also be given the opportunity to provide feedback on the service.
This project will further develop and test the Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses (TTIP-PRO), a promising, low-cost, intervention to facilitate entry into medication assisted treatment (MAT) for individuals experiencing a non-fatal opioid overdoses (OOD). A prior small-scale pilot/feasibility study of TTIP-PRO (NCT02282306) found that the participating patients and the Peer Interventionists were satisfied with their participation, the intervention was acceptable, and the system for generating patient-tailored intervention information performed well. The overall goal of the present study is to conduct a pilot randomized controlled trial of TTIP-PRO versus a control group. It is hypothesized that patients in the TTIP-PRO group will have more favorable drug-abuse-related outcomes than patients in the control group.
The goal of this study is to test the feasibility, acceptability and preliminary impact of peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally Occurring Retirement Communities (NORC) residents or senior center participants.
Patient-Centered Trauma Treatment, i.e., treatment delivered by peers with lived-experience, has the potential to increase access to trauma treatment in underserved communities. This could positively impact the lives of millions of people as 70% of adults in the U.S have experienced a traumatic event and the consequences of trauma are devastating and far reaching, including chronic and comorbid physical and mental health problems. The most known consequences of trauma include post-traumatic stress disorder (PTSD) and substance use disorders (SUDs). Seeking Safety (SS) is the most effective evidenced-based treatment for co-occurring trauma, PTSD and SUDs. While no specific degree or experience level is required to conduct SS, all the evidence comes from studies using trained clinicians to implement the treatment, including social workers, psychologists, and psychiatrists. However, these research findings do not generalize to underserved communities that lack mental health professionals. Innovative approaches to treatment, such as peer-delivered services, are required to meet the demand for care in underserved areas. While the benefits of peer-delivered services have been well-documented in many areas, the value of peers in the provision of trauma-treatment is unknown. A theoretical basis supports the potential for peer-delivered trauma-treatment to be effective in addition to the strong therapist-patient bond, (i.e. therapeutic alliance (TA), which is an important predictor of treatment outcome and a typical result of peer-patient relationships. Our research question is whether there is a difference between peer-led SS (PL-SS) groups and clinician-led SS (CL-SS) groups in improving the lives of people with trauma, PTSD and SUDs? The investigators have three specific aims: 1. Determine the effectiveness of PL-SS groups compared to CL-SS groups in decreasing substance use and PTSD symptoms and improving coping skills, overall mental health and physical health. Hypothesis: PL-SS compared to CL-SS groups will be as effective in improving outcomes. 2. Compare levels of TA among PL-SS and CL-SS groups and examine the impact of TA on outcomes.Hypotheses: Levels of TA will be higher and will play more of a role in impacting outcomes in the PL-SS compared to CL-SS groups. 3. Determine if the standard Seeking Safety Instructor Training (SS-IT) is adequate for peers. Hypothesis: Peers will identify topics that will enhance the SS-IT.
The purpose of this study was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.
This research project will refine and evaluate delivery of a peer-delivered evidence-based intervention to improve perceived access and actual engagement with mental health treatment and social resource service use among rural women Veterans, especially Veterans of color, with psychological distress and unmet social needs.
Women have double the odds of getting depressed as men and commonly experience depression during the childbearing and early parenting years. Many new and expectant mothers who experience depression never receive help. Alma is a new program, collaboratively developed by a team of researchers, clinicians, and mothers who have personal experience with depression, to support women experiencing depression during pregnancy and the postpartum period. In the Alma program, mothers who themselves have experienced and recovered from depression during the perinatal period, are trained to provide peer mentoring to depressed new and expectant mothers. Peer mentors are trained by professionals who are experts in using skills to recover from depression. These skills are informed by an evidence-based framework called Behavioral Activation (BA). Peer mentors do not provide psychotherapy and are not licensed mental health providers.
This proposal seeks to adapt an existing peer navigation protocol (by adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.
The number of autistic adults reached 5.4 million in the United States in 2017 and is projected to continue to rise, but evidence-based practices to optimize their health and well-being are limited and poor outcomes are common. This study will leverage existing infrastructure to finalize the development of a novel support service provided by peers with lived experience, incorporating input from autistic peer specialists, autism researchers, peer support researchers, and experts in peer support training. Investigators will then conduct a pilot randomized controlled trial to examine the effectiveness of the service while also examining the feasibility, acceptability, and implementation procedures in preparation for future large-scale testing and dissemination.
The VetASSIST study is a randomized clinical trial testing whether receiving virtual health coaching from Veteran peers improves the physical and mental health-related quality of life of Veterans with multiple chronic health conditions and complex healthcare needs. VetASSIST will test the efficacy of an intervention that matches Veteran patients with multimorbidty with Veteran health coaches who will provide education, resources, guidance and support to help them manage their physical and mental health over the course of a year.
Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system. The study will be conducted in 2 phases with corresponding aims. In Phase 1 (Aim 1), 4 focus groups with Black WLHA with experiences of interpersonal violence, one focus group with peer navigators, and 4-6 key informant interviews with providers will be conducted to determine which app features, content, and functions are most likely to support downloading, initiating use, and sustaining engagement over time. Aim 1 will culminate in usability testing by Black WLHA affected by interpersonal violence (n=8), to finalize intervention components and procedures. In Phase 2 (Aim 2), investigators will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of the intervention on HIV care outcomes (i.e., retention in care, ART adherence, viral suppression) and mechanism of change variables (i.e., social support, self-efficacy). Through a randomized control trial (RCT), participants will be randomly assigned to either the intervention arm (n=40) or control arm (Ryan White standard of care, n=40), with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking-all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.
The "Thrive With Me" (TWM) trial is testing the efficacy of a mobile enhanced website aimed at improving Antiretroviral Therapy (ART) adherence for HIV-positive men who have sex with men (MSM). TWM is a technology-delivered peer-to-peer social support intervention with social networking and gaming components. In addition to real-time peer-to-peer support capabilities, the TWM intervention provides participants with Antiretroviral Therapy (ART) adherence self-monitoring tools, medication dose reminders, and HIV-related informational content.
Fifteen to twenty percent of older Americans (6 to 8 million people) suffer from depression but more than one-half do not receive any services, a burden disproportionately shared by low-income and minority older adults who receive few or no services. The investigators propose to test a community-based peer model of depression care called PEERS (a peer support program) that provides self-care support for minority and low-income older adults.
The Veterans Health Administration (VHA) is advocating that Veterans with serious mental illness (SMI) receive recovery-oriented, rehabilitation approaches that target real-world functioning. One such approach is Cognitive-Behavioral Social Skills Training (CBSST). Unlike traditional cognitive-behavioral therapy, CBSST is a more recovery-oriented psychosocial rehabilitation intervention that teaches Veterans with SMI to correct errors in thinking and build social skills. While effective, CBSST has only been tested when facilitated by masters- or doctoral-level therapists, which limits its use in VHA. However, the investigators' pilot data shows that Peer Specialists-individuals with SMI who are hired and trained to use their own recovery experience to assist others with SMI-can also provide CBSST (called CBSST-Peer). Stand-alone social skills training (SST) is also a recovery-oriented program that VHA is attempting to rollout nationwide for Veterans with SMI. A few Peer Specialists have been trained to co-lead SST with professionals. However, SST is not widely implemented because professionals are busy and Peer Specialist delivered SST has not been tested. This study will evaluate the effectiveness of Peer Specialist-delivered CBSST and SST, which would increase access Veterans with SMI have to effective treatment. The investigators' aims are: Aim 1 (Effectiveness): To compare the impact of CBSST-Peer on outcomes in Veterans with SMI to Veterans receiving Peer Specialist-delivered SST groups of equal duration and to treatment as usual. The investigators will also assess fidelity of SST and CBSST. Aim 2: (Helpfulness of CBSST/SST--Peer and implementation barriers and facilitators): To use focus groups with patients and interviews with Peer Specialists and other staff to assess perceptions of SST- and CBSS Peer and identify potential barriers and facilitators to future implementation. Methods: This is a randomized, Hybrid 1 trial involving 252 Veterans with SMI (n=126 each from Pittsburgh, San Diego) comparing 3 treatment arms: CBSST-Peer vs. SST-Peer vs. treatment as usual. Hybrid 1 trials test the effectiveness of an intervention and collect implementation data that could inform its future adoption. At each site, across 6 waves (a wave = 1 CBSST-Peer and 1 SST-Peer group), 2 Peer Specialists will co-lead 12 groups, each lasting 20 weeks. Peer Specialists will be trained and receive an hour of supervision weekly by the CBSST developers. Master trainers from the SST rollout will train and supervise Peer Specialists in each site. All three arms' sessions will be taped and 25% rated for fidelity on standardized measures. A survey battery that assesses functioning, quality of life, recovery, and symptoms will be administered to the Veterans in each wave at: baseline, mid-intervention (10 weeks), end-of-intervention (20 weeks), and follow-up (32 weeks, 3 months post intervention). The investigators will examine all outcomes using Hierarchical Linear Models (HLM), with treatment condition included as a time-invariant covariate, and random intercepts for person and random slopes for time. Relevant covariates will include site, treatment attendance, symptom severity, service use, and demographic variables. The investigators will evaluate the effect for treatment conditions (CBSST-Peer vs. SST-Peer vs. treatment as usual group) in the expected direction and the time X group effect. Qualitative data on SST- and CBSST-Peer helpfulness and implementation factors will be collected from 8 focus groups, audio-recorded from a random sample of Veterans who participated in SST- and CBSST-Peer. Interviews will be conducted with participating Peer Specialists (n=approximately 8 per site), and key mental health staff (n=3-4 per site). The qualitative interviews and focus groups will be analyzed using rapid assessment, a team-based, iterative data collection and analysis approach providing data on the barriers and facilitators to future implementation of SST- and CBSST-Peer. Innovation: No study has tested peer-delivered SST or CBSST, or compared the two, in a rigorous trial. Significance/Expected Results: CBSST and SST are not widely available. If SST- or CBSST-Peer is effective, it could greatly increase the delivery of evidence-based services Veterans receive and enhance the services by VHA Peer Specialists.
Can peer mentors be integrated into depression care to older adults with mental health professional supervision? We will assess whether peer mentors who are lay persons who are in recovery from depression can provide depression care services to older adults with depression. Older adults who are 50 and older will be screened for depression in the clinic and community. Those who meet criteria will be paired with a peer mentor for 8 meetings. Peer mentors will audiorecord their meetings with the patient and the recordings will be analyzed to assess what kinds of communication and behaviors the peer mentors engage in and what among those communications may be associated with relieving depression. The peer mentor will be trained and supervised by a psychiatrist and they will form a team to provide the depression care to the older adult. The study aims to relieve depressive symptoms and engage older adults in care. Both older adults and peer mentors wil be interviewed after the study to assess the strengths and weaknesses of peer mentor delivery of depression care. A manual will be developed describing the process and procedures of the study.
This project will evaluate 3 approaches of implementation support for university peer leaders who will deliver a prevention program with a particularly strong evidence-base compared to changes observed in outcomes in response to usual care at the universities before implementation. This study aims to advance knowledge of this innovative and economical way to provide college prevention programs to reduce the burden of mental illness in the college student population.
The purpose of this study is to evaluate the impact of the school-based Sources of Strength program in reducing suicidal behaviors in the population of high school students and determine how the program works (mechanisms of change). Sources of Strength trains diverse high school students as Peer Leaders, who conduct school-wide prevention messaging activities with ongoing adult mentoring designed to increase positive coping norms and practices, help-seeking and increase youth-adult connections. Sources of Strength is expected to enhance school coping practices, increase help-seeking among distressed and suicidal youth, and reduce the number of students in the population who attempt suicide. A total of 40 high schools in primarily rural and micropolitan regions of New York State and North Dakota will participate in this study that uses a randomized wait-listed design.