The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Location status: Recruiting
NCT Number: NCT07051200
The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services.
The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources.
The intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO).
Participants will be assigned to either Cohort A or B for 8 weeks.
Cohort A will be the intervention group with PSS and RCOs.
* Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4. * Weeks 5 and 7: One-on-one meetings with PSS for education and support. * Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks.
Cohort B will be the SOC group with no PSS or RCOs.
* Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8.
Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.
Interested in participating?
Request Info18 year–27 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75390, United States
Location status: Recruiting
Purpose
Objectives
Endpoints
Study Design This is a 1:1 randomized, 8-week interventional study that will include an orientation session and a collection of baseline data. At the conclusion of the orientation session, subjects will be randomly assigned to Cohort A or B. Target recruitment is 40 subjects for this pilot study; 20 subjects in cohort A and 20 in cohort B. At the conclusion of the study, both groups will be provided a list of resources for therapy, outpatient psychiatry providers/services, RCOs, local emergency departments and inpatient psychiatric facilities.
Cohort A - Intervention group with PSS and RCOs
Cohort B - SOC group with no PSS or RCOs; participants are responsible for finding resources or group support by following the information provided at discharge
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A program of mental health recovery through one-on-one and small group meetings with a PSS and RCOs for individuals recently discharged from an acute care psychiatric facility.
Time frame: Weeks 2, 4, 6, and 8.
The intervention in this study will use peer support specialist (PSS) and recovery community organization (RCO) programs to improve knowledge, awareness, and utilization of recovery and wellness programs.
Connecting patients with a PSS and recovery organizations has been associated with an improvement in patient outcomes - including a change in the incidences of suicide/attempted suicide.
Changes in suicide ideation and consequently the mortality from suicide will be determine by administrating the Columbia Suicide Severity Rating Scale (C-SSRS) using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity.
Changes is scores will be analyzed to determine the effectiveness of the intervention.
Time frame: Weeks 2, 4, 6 and 8
A reduction of anxiety and depression symptoms and rates of occurrence will be measured using the following standardized assessments:
Responses on each assessment at each time point specified in the protocol, will be reviewed for changes (as indicating by the scoring of frequency or severity) to determine the efficacy of the intervention.
Contact information is provided by the study sponsor or research team.
University of Texas Southwestern Medical Center
Other
Acronym: RISE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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