Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07051200

Recovery Through Inspiration, Support, and Empowerment

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

About this study

Purpose

  • This is a pilot study to test the effectiveness of a novel intervention aimed at reducing the incidences of suicidality, depression, anxiety, re-hospitalization rates, and improving mental health recovery by utilizing outpatient services, and medication adherence for young adults (18-27) with mental health conditions verses the standard of care (SOC) at discharge which only provides a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources.
  • The intervention will use peer support specialist (PSS) and recovery community organizations (RCO) aimed at improving knowledge, awareness, and utilization of recovery and wellness programs for those patients recently discharged from an acute psychiatric treatment facility.

Objectives

  • Implement a program of mental health recovery education and support through one-on-one and small group meetings with a PSS and RCOs for individuals recently discharged from an acute care psychiatric facility to determine the effectiveness of: Reduction of suicidality, depression, anxiety, re-hospitalization rate AND Improvement in mental health recovery by participating in outpatient services, and medication adherence.
  • Determine if peer-led interventions improve knowledge, awareness, and utilization of recovery and wellness programs and support.

Endpoints

  • Determine the efficacy of peer-led, one-on-one and group sessions vs standard of care (SOC) based on responses to assessments, adherence to medication, and re-admittance to a psychiatric facility.
  • Determine if there is a difference in outcome based on demographics (age, race, ethnic background, diagnosis, public vs private insurance, and zip code)

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

  • Weeks 1-4: one-on-one meetings with peer support specialist (PSS) for education and support. Qualitative and quantitative assessments completed at weeks 2 and 4
  • Weeks 5-8: Biweekly (every other week) of one-on-one meetings with PSS for education and support. Biweekly group meetings with PSS and other participants. Qualitative and quantitative assessments completed at weeks 6 and 8

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

  • Weeks 1-4: Weekly check-in phone calls with a member of the research team. Qualitative and quantitative assessments completed at weeks 2 and 4 (completed during phone call check in)
  • Weeks 5-8: Biweekly (every other week) check-in phone calls with a member of the research team. Qualitative and quantitative assessments completed at weeks 6 and 8 (completed during phone call check in).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chief complaint of suicidal ideation, suicide attempt, depression, and/or anxiety
  • discharged from inpatient care or from emergency department
  • men and women ages 18-27

Exclusion criteria

  • primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)

Treatment and study plan

Peer Support Services Recovery

Behavioral

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.

Primary outcomes

  1. Change in suicidal ideation

    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.

Secondary outcomes

  1. Changes in symptoms associated with anxiety and depression

    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:

    • Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms over the past two weeks.
    • The Patient Health Questionnaire (PHQ) - a self reported inventory used as a screening and diagnostic tool for depression.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Noureen Hoq

CONTACT

[email protected]

214-648-0311

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: RISE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 4, 2025
Registry last updated
Jun 25, 2026

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.

Published trials that share one or more normalized conditions with this study.