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Clinical Trial Summary

The purpose of this study is to evaluate how well three types of treatments work to improve the outcomes for people with substance use problems. Veterans admitted to the Charleston VA Psychiatric inpatient unit may be invited to participate. The three types of treatments that will be evaluated are: 1. Combined Recovery Program (CRP), a six-session treatment group delivered on the inpatient unit. 2. A Home Telehealth program, called Stable and Able (S&A), provided just prior to discharge and provides additional support for up to 3 months 3. Treatment-as-usual (TAU), which is the treatment currently provided on the unit, consisting of various mental health topics and sessions designed to help with recovery. Participation begins on the inpatient unit, beginning with CRP and/or TAU, and may continue with S&A post discharge. Participants will be followed up at 1 and 3- months post treatment.


Clinical Trial Description

Background: High inpatient readmissions among Veterans with substance use disorders (SUD) constitutes a costly and persistent healthcare problem. Studies demonstrate that patients with SUDs return to inpatient treatment multiple times and that high inpatient service utilization in this population is associated with high rates of co-occurring mental illness (SUD/MI), homelessness, suicidality, and continued impairment in health and social functioning. A significant proportion (21%) of Veterans with SUD/MI are homeless, at high-risk for suicide, and represent one of the largest, most chronic groups of psychiatric patients treated in the VA Healthcare System. In effort to ameliorate inpatient readmission rates, VHA Handbook 1160.06, drafted in 2013, espouses the development and implementation of uniform recovery-oriented mental health (MH) services, which include treatment of SUDs addressing goals of recovery, improved quality of life, and community integration. The three types of treatments that will be evaluated are: 1. Combined Recovery Program (CRP), a six-session treatment group designed to explore goals, values, and personal strengths about making a change for overall quality of life, health and well-being combined with skill building designed for helping to live a more stable life in their own home that will include money management for financial success and home maintenance. 2. A Home Telehealth program, called Stable and Able (S&A), designed to help maintain skills to stay sober and allows continued communication with one of the mental health staff on a daily basis to provide additional support for the next 3 months after discharge. 3. Treatment-as-usual (TAU), which is the treatment currently provided on the unit, consisting of various mental health topics and sessions designed to help with recovery. All participant will receive TAU. Objectives: Specific Aim I: Assess the relative effects of Treatment Engagement and Substance Use [and SUD-related problems] between CRP+S&A+TAU vs. CRP+TAU and CRP+S&A+TAU vs. TAU only by 3-mos follow-up. Primary Hypothesis 1a: Treatment Engagement: Participants in CRP + S&A+TAU will attend more outpatient SUD treatment sessions and general MH treatment sessions compared to participants in CRP and to TAU. Primary Hypothesis 1b: Substance Use: Participants in CRP + S&A+TAU will lower quantity and frequency of substance use and SUD-related problems compared to participants in CRP+TAU and to TAU only. Secondary Hypothesis 1c: Preventable Services: Participants in CRP + S&A+TAU will reduce Preventable Healthcare Services (hospital readmissions and emergency department visits) compared to participants in CRP+TAU and to TAU only. Secondary Hypothesis 1d: Participants in CRP + S&A+TAU will report Greater QoL; # of Days Living in Stable Housing; and # of Days Engaging in Community Events and/or Activities compared to CRP+TAU and to TAU only. Specific Aim II: Conduct Veteran participant and Staff thematic interviews and to assess qualitative facilitators and barriers to implementation. Methods: 195 Veterans with SUDs admitted into the Charleston VAMC inpatient unit will be recruited. Participants will be randomly assigned to: (1) CRP + S&A + TAU; (2) CRP+TAU; and (3) TAU. All participants will be followed-up at 1 and 3-months and data analyzed using mixed methods. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05054738
Study type Interventional
Source VA Office of Research and Development
Contact Elizabeth J Santa Ana, PhD MA BA
Phone (843) 789-7168
Email Elizabeth.SantaAna2@va.gov
Status Recruiting
Phase N/A
Start date September 6, 2022
Completion date December 31, 2025

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