NCT07051200

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Apr 2025Dec 2026

Study Start

First participant enrolled

April 1, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

April 30, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

Peer Support Specialist (PSS)Recovery Community Organization (RCO)Mental Health RecoveryTransitional Age Youth (TAY)UT Southwestern Medical CenterYoung Adult

Outcome Measures

Primary Outcomes (1)

  • Change in suicidal ideation

    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.

    Weeks 2, 4, 6, and 8.

Secondary Outcomes (1)

  • Changes in symptoms associated with anxiety and depression

    Weeks 2, 4, 6 and 8

Study Arms (2)

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.

Behavioral: Peer Support Services Recovery

Cohort B: Standard of Care

NO INTERVENTION

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

Interventions

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.

Cohort A: Intervention group with PSS and RCOs

Eligibility Criteria

Age18 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (3)

  • Davidson L, Bellamy C, Guy K, Miller R. Peer support among persons with severe mental illnesses: a review of evidence and experience. World Psychiatry. 2012 Jun;11(2):123-8. doi: 10.1016/j.wpsyc.2012.05.009.

    PMID: 22654945BACKGROUND
  • Walker G, Bryant W. Peer support in adult mental health services: a metasynthesis of qualitative findings. Psychiatr Rehabil J. 2013 Mar;36(1):28-34. doi: 10.1037/h0094744.

    PMID: 23477647BACKGROUND
  • Lyons N, Cooper C, Lloyd-Evans B. A systematic review and meta-analysis of group peer support interventions for people experiencing mental health conditions. BMC Psychiatry. 2021 Jun 23;21(1):315. doi: 10.1186/s12888-021-03321-z.

    PMID: 34162340BACKGROUND

Related Links

MeSH Terms

Conditions

Suicidal IdeationSuicide, AttemptedAnxiety Disorders

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Joseph Guillory, M.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pham

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cohort A: Intervention Group Cohort B: Standard of Care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 30, 2025

First Posted

July 4, 2025

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

At this time - there is no intention of sharing individual participant data as this is a pilot study, and due to the relatively small number of participants, any data that is shared or published will be in aggregate.

Locations