NCT05054738

Brief 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. 1.Combined Recovery Program (CRP), a six-session treatment group delivered on the inpatient unit.
  2. 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Sep 2022

Longer than P75 for not_applicable

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 Progress85%
Sep 2022Dec 2026

First Submitted

Initial submission to the registry

September 2, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

September 2, 2021

Last Update Submit

April 27, 2026

Conditions

AlcoholismSubstance-related DisordersDual Diagnosis

Keywords

AlcoholismSubstance-related disordersDual Diagnosis

Outcome Measures

Primary Outcomes (27)

  • Standard Ethanol Content Units (SECs) Baseline

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol at Baseline (e.g., the past 30 days is defined as 'Baseline'). Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.

    Baseline

  • Standard Ethanol Content Units (SECs) at 1 month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after the first day of treatment. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.

    1 month

  • Standard Ethanol Content Units (SECs) at 3 month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days after the 1-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.

    3 Month

  • Peak SEC at Baseline

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to baseline. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed in a single day within the stated time period.

    Baseline

  • Peak at 1 Month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after the first day of treatment. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed in a single day within the stated time period.

    30 days

  • Peak at 3 Month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days after the 1-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed in a single day within the stated time period.

    3 Month

  • Alcohol Drink Days at Baseline

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to Baseline. This measure represents the number of days any alcohol was consumed within the stated time period.

    Baseline

  • Alcohol Drink Days at 1 Month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after the first day of treatment. This measure represents the number of days any alcohol was consumed within the stated time period.

    30 days

  • Alcohol Drink Days at 3 Month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days after the 1-month follow-up. This measure represents the number of days any alcohol was consumed within the stated time period.

    3 Month

  • Binge Drink Days at Baseline

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to Baseline. This measure represents the number of days the participant binge drank.

    Baseline

  • Binge Drink Days at 1 month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after the first day of treatment. This measure represents the number of days the participant binge drank within the stated time period.

    1 month

  • Binge Drink Days at 3 Month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days after the 1-month follow-up. This measure represents the number of days the participant binge drank within the stated time period.

    3 month

  • Illicit Drug Use Days at Baseline

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of drug use in the 30 days prior to Baseline. This measure represents the number of illicit drug use days within the stated time period.

    Baseline

  • Illicit Drug Use Days at 1 Month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of drug use in the 30 days after the first day of treatment. This measure represents the number of illicit drug use days within the stated time period.

    30 days

  • Illicit Drug Use Days at 3 month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of drug use in the 60 days after the 1-month follow-up. This measure represents the number of illicit drug use days within the stated time period.

    3 Month

  • Substance Use Disorder Treatment Sessions at Baseline

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Electronic Health Record System for the 30 days prior to Baseline. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.

    Baseline

  • Substance Use Disorder Treatment Sessions at 1 month

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Electronic Health Record System for the 30 days after the first day of treatment. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.

    30 days

  • Substance Use Disorder Treatment Sessions at 3 Month

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Electronic Health Record System for the 30 days after the 1-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.

    3 Month

  • Twelve-Step Sessions Attended at Baseline

    A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days prior to Baseline.

    Baseline

  • Twelve-Step Sessions Attended at 1 Month

    A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days after the first day of treatment.

    30 days

  • Twelve-Step Sessions Attended at 3 month

    A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 60 days after the 1-month follow-up.

    3 Month

  • Community Participation Activities at Baseline

    A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 30 days prior to Baseline.

    Baseline

  • Community Participation Activities at 1 month

    A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 30 days after the 1st day of treatment.

    30 days

  • Community Participation Activities at 3 month

    A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game)in the 60 days after the 1-month follow-up.

    3 Month

  • Mental Health Treatment Sessions at Baseline

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 30 days prior to Baseline. Treatment sessions included individual sessions with outpatient mental health staff.

    Baseline

  • Mental Health Treatment Sessions at 1 month

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 30 days after discharge. Treatment sessions included individual sessions with outpatient mental health staff.

    30 days

  • Mental Health Treatment Sessions at 3 month

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 60 days after the 1-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.

    3 Month

Secondary Outcomes (25)

  • Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use

    Baseline

  • Addiction Severity Index-Lite (ASI-Lite) at 1 month for Alcohol Use

    30 days

  • Addiction Severity Index-Lite (ASI-Lite) at 3 month for Alcohol Use

    3 Month

  • Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status

    Baseline

  • Addiction Severity Index-Lite (ASI-Lite) at 1 month for Psychiatric Status

    30 days

  • +20 more secondary outcomes

Study Arms (3)

Combined Recovery Program (CRP)+Treatment-as-usual (TAU)

EXPERIMENTAL

Combined Recovery Program (CRP) is a six-session motivational enhancement and daily living skills therapy workshop provided while on the inpatient unit. Attendance of CRP will be in addition to Treatment as Usual (TAU), that is, standard inpatient programming.

Behavioral: Combined Recovery Program

CRP+ Stable & Able (S&A)+TAU

ACTIVE COMPARATOR

Combined Recovery Program (CRP) a six-session motivational enhancement and daily living skills therapy workshop provided while on the inpatient unit, plus a home telehealth program (Stable \& Able) which begins on day 1 of hospital discharge. Attendance of CRP and S\&A will be in addition to TAU, that is, standard inpatient programming.

Behavioral: Combined Recovery ProgramBehavioral: Stable & Able (S&A)

Treatment-as-usual only (TAU):

NO INTERVENTION

TAU will only receive the usual care on the inpatient unit including medical and medication management.

Interventions

Combined Recovery ProgramBEHAVIORAL

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.

CRP+ Stable & Able (S&A)+TAUCombined Recovery Program (CRP)+Treatment-as-usual (TAU)
Stable & Able (S&A)BEHAVIORAL

A 90-day Home Telehealth program designed to help maintain skills to stay sober.

CRP+ Stable & Able (S&A)+TAU

Eligibility Criteria

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

You may qualify if:

  • Meeting DSM-V criteria for current SUD diagnosis of alcohol and/or illicit drug use disorder
  • Use of substances in past 30 days prior to date of index inpatient admission
  • Able to comprehend English
  • Able to provide informed consent
  • Functioning at an intellectual level sufficient to allow accurate completion of all assessments
  • Willing to commit to 6 group inpatient therapy sessions, telehealth S\&A, as well as baseline, and 1-and 3-month follow-up assessments

You may not qualify if:

  • Auditory or visual impairment that would interfere with study procedures
  • Inability to speak or understand English
  • Acutely psychotic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Elizabeth J. Santa Ana, PhD MA BA

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth J Santa Ana, PhD MA BA

CONTACT

(843) 789-7168Elizabeth.SantaAna2@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The PI and research staff providing follow up assessments will be blinded to participants study condition
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Between groups randomized controlled trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 23, 2021

Study Start

September 6, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)