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Clinical Trials/NCT07051200
NCT07051200RecruitingNot Applicable

Recovery Through Inspiration, Support, and Empowerment

University of Texas Southwestern Medical Center1 site in 1 country40 target enrollmentStarted: April 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Change in suicidal ideation

Study Overview

Brief Summary

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 27 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Cohort A: Intervention group with PSS and RCOs

Experimental

One on one meetings peer support specialist (PSS) for education and support. Group meetings with PSS and other participants. Qualitative and quantitative assessments.

Intervention: Peer Support Services Recovery (Behavioral)

Cohort B: Standard of Care

No Intervention

Scheduled telephone call visit with a member of the research team. Qualitative and quantitative assessments.

Outcomes

Primary Outcomes

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

  • Changes in symptoms associated with anxiety and depression(Weeks 2, 4, 6 and 8)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joseph Guillory

Assistant Professor

University of Texas Southwestern Medical Center

Study Sites (1)

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