NCT05758376

Brief Summary

The time following discharge from psychiatric hospitalization is a high-risk period and has been associated with a range of negative outcomes including high rates of hospital readmission and suicide. The purpose of this proposal is to: 1) create a Peer Specialist facilitated intervention, called Recovery Bridge, designed to facilitate the transition from inpatient psychiatric hospitalization to community living; 2) examine feasibility, fidelity, and acceptability; and preliminarily explore the impact of the intervention on: a) readmission rates and connection to outpatient care compared to a control group identified from administrative data; and b) change in recovery and quality of life measures over time in the intervention participants. Results from the proposed open pilot trial will set the stage for next steps including a larger effectiveness trial followed by a possible hybrid-I effectiveness/implementation trial to inform future dissemination and implementation of the intervention more broadly across the VA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 23, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 11, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

February 23, 2023

Results QC Date

December 11, 2025

Last Update Submit

April 1, 2026

Conditions

Keywords

VeteranIn-patient

Outcome Measures

Primary Outcomes (5)

  • Feasibility 1: Recruitment Benchmark

    Recruitment (number consented divided by number approached)

    3 months

  • Feasibility 2: Intervention Engagement (Percentage of Sample That Completes at Least 3 Intervention Sessions-with One of the Three Occurring Inpatient

    Percentage of sample that completes at least 3 intervention sessions-with one of the three occurring inpatient

    3 months

  • Feasibility 3: Drop Out Rate (Percent That Did Not Complete Post-intervention Assessment)

    Drop out Rate: Percent that do not complete post-intervention assessment (based on count of participants)

    3 months

  • Fidelity

    Greater than 90% of all Adherence and Competence Items Rated as Acceptable or Higher. Higher ratings of acceptability are considered to be the better outcome.

    3 months

  • Acceptability (Patient Satisfaction Questionnaire--administered Post Intervention)

    Score of 26 percent or higher on Patient Satisfaction Questionnaire. Scale ranges from 8-32, higher score is associated with "better outcome" (i.e. higher satisfaction).

    3 months

Study Arms (1)

Recovery Bridge

EXPERIMENTAL

Open trial single arm pilot study

Behavioral: Recovery Bridge

Interventions

Recovery BridgeBEHAVIORAL

Recovery Bridge is a Peer Specialist facilitated intervention designed to help Veterans being discharged from an inpatient psychiatric hospitalization bridge the gap to outpatient care and community living

Recovery Bridge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • enrolled in the inpatient program
  • planned discharge to the community

You may not qualify if:

  • Inability to provide consent
  • No access to either a computer or a telephone after discharge (as at least one of these will be needed should the Veteran and PS interventionist decide to continue to meet remotely)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Mental Disorders

Results Point of Contact

Title
Richard Goldberg, Ph.D. (Principal Investigator)
Organization
VISN 5 MIRECC

Study Officials

  • Richard W Goldberg, PhD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Open Pilot Trial (n=15) to examine feasibility, fidelity, and acceptability of study intervention (called Recovery Bridge)
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 7, 2023

Study Start

December 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 22, 2026

Results First Posted

February 11, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations