AlcoholismCRP and S&ANCT05054738
CRP and S&A for Inpatient Veterans
A study testing Combined Recovery Program and Stable & Able (S&A) in people with Alcoholism and Substance-related Disorders, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Substance-related Disorders, Dual Diagnosis
- What is being tested?
- Combined Recovery Program and Stable & Able (S&A)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Auditory or visual impairment that would interfere with study procedures
- Inability to speak or understand English
- Acutely psychotic patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
About this study
Official title: Impact of Combined Recovery Program and Home Telehealth Among Veterans With Substance Use Disorders in the VA Inpatient Setting
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:
- Combined Recovery Program (CRP), a six-session treatment group delivered on the inpatient unit.
- A Home Telehealth program, called Stable and Able (S\&A), provided just prior to discharge and provides additional support for up to 3 months
- 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.
Read the detailed 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:
- 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.
- 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.
- 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.
- Conditions
- Alcoholism, Substance-related Disorders, Dual Diagnosis
- Being tested
- Combined Recovery Program, Stable & Able (S&A)
- Keywords
- Alcoholism, Substance-related disorders, Dual Diagnosis
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Recovery ProgramBehavioural
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.
Stable & Able (S&A)Behavioural
A 90-day Home Telehealth program designed to help maintain skills to stay sober.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Combined Recovery Program; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 Month
Secondary outcomes (25)
Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use
The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
Measured: Baseline
Addiction Severity Index-Lite (ASI-Lite) at 1 month for Alcohol Use
The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
Measured: 30 days
Addiction Severity Index-Lite (ASI-Lite) at 3 month for Alcohol Use
The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
Measured: 3 Month
Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status
The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
Measured: Baseline
Addiction Severity Index-Lite (ASI-Lite) at 1 month for Psychiatric Status
The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
Measured: 30 days
Addiction Severity Index-Lite (ASI-Lite) at 3 month for Psychiatric Status
The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
Measured: 3 Month
Short Inventory of Problems (SIP) at Baseline
Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
Measured: Baseline
Short Inventory of Problems (SIP) at 1 month
Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
Measured: 30 days
Short Inventory of Problems (SIP) at 3 month
Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
Measured: 3 Month
Quality of Life Survey (QOLS) at Baseline
Min value:16 Max value:112 Higher score indicates higher quality of life
Measured: Baseline
Quality of Life Survey (QOLS) at 1 month
Min value:16 Max value:112 Higher score indicates higher quality of life
Measured: 30 days
Quality of Life Survey (QOLS) at 3 month
Min value:16 Max value:112 Higher score indicates higher quality of life
Measured: 3 Month
Brief Symptom Inventory (BSI-18) at Baseline
Min value:0 Max value:72 Higher score indicates higher psychological distress
Measured: Baseline
Brief Symptom Inventory (BSI-18) at 1 month
Min value:0 Max value:72 Higher score indicates higher psychological distress
Measured: 30 days
Brief Symptom Inventory (BSI-18) at 3 month
Min value:0 Max value:72 Higher score indicates higher psychological distress
Measured: 3 Month
Treatment Motivation Questionnaire (TMQ) at Baseline
The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged
External:
Min value:1 Max value:7 External: Higher score indicates higher external reasons for attending treatment (e.g. referred to treatment by legal system)
Internal:
Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)
Measured: Baseline
Treatment Motivation Questionnaire (TMQ) at 1 month
The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged
External:
Min value:1 Max value:7 External: Higher score indicates higher external reasons for attending treatment (e.g. referred to treatment by legal system)
Internal:
Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)
Measured: 30 days
Treatment Motivation Questionnaire (TMQ) at 3 month
The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged
External:
Min value:1 Max value:7 External: Higher score indicates higher external reasons for attending treatment (e.g. referred to treatment by legal system)
Internal:
Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)
Measured: 3 Month
Fagerstrom Test for Nicotine Dependence at Baseline
Min:0 Max:10 Higher score indicates higher level of nicotine dependence
Measured: Baseline
Preventable Healthcare Services at 1 month Baseline
A Treatment Attendance Calendar was used to record the number of separate psychiatric inpatient admissions and emergency department visits documented in each participants VA Computerized Patient Record System for the 30 days prior to Baseline.
Measured: 30 days
Preventable Healthcare Services at 1 month
A Treatment Attendance Calendar was used to record the number of separate psychiatric inpatient admissions and emergency department visits documented in each participants VA Computerized Patient Record System for the 30 days after discharge.
Measured: 30 days
Preventable Healthcare Services at 3 month
A Treatment Attendance Calendar was used to record the number of separate psychiatric inpatient admissions and emergency department visits documented in each participants VA Computerized Patient Record System for the 60 days after the 1-month follow-up.
Measured: 3 Month
Housing Status Inventory at Baseline
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of housing status for the 30 days prior to Baseline.
Measured: Baseline
Housing Status Inventory at 1 month
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of housing status for the 30 days after discharge.
Measured: 30 days
Housing Status Inventory at 3 month
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of housing status for the 60 days after the 1-month follow-up
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start6 Sep 2022
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between groups randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elizabeth J. Santa Ana, PhD MA BA, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054738
- Sponsor's protocol ID
- IIR 19-395
- Acronym
- CRP and S&A
- Status last verified
- Jul 2026
- First submitted
- 2 Sep 2021
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combined Recovery Program and Home Telehealth Among Veterans With Substance Use Disorders in the VA Inpatient Setting
- ClinicalTrials.gov ID
- NCT05054738
- Acronym / sponsor ID
- CRP and S&A / IIR 19-395
- Conditions
- Alcoholism, Substance-related Disorders, Dual Diagnosis
- Keywords
- Alcoholism, Substance-related disorders, Dual Diagnosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 197 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Combined Recovery Program (CRP), a six-session treatment group delivered on the inpatient unit.
- A Home Telehealth program, called Stable and Able (S\&A), provided just prior to discharge and provides additional support for up to 3 months
- 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.
Detailed 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:
- 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.
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Between groups randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Combined Recovery Program (CRP)+Treatment-as-usual (TAU) | Experimental | Behavioral: Combined Recovery ProgramCombined 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. |
| CRP+ Stable & Able (S&A)+TAU | Active comparator | Behavioral: Combined Recovery Program, Behavioral: Stable & Able (S&A)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. |
| Treatment-as-usual only (TAU): | No intervention | –TAU will only receive the usual care on the inpatient unit including medical and medication management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Auditory or visual impairment that would interfere with study procedures
- Inability to speak or understand English
- Acutely psychotic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Recovery ProgramA 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. | Behavioural | CRP+ Stable & Able (S&A)+TAU, Combined Recovery Program (CRP)+Treatment-as-usual (TAU) |
| Stable & Able (S&A)A 90-day Home Telehealth program designed to help maintain skills to stay sober. | Behavioural | CRP+ Stable & Able (S&A)+TAU |
Primary outcome
Standard Ethanol Content Units (SECs) Baseline
Time frame: 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.
Standard Ethanol Content Units (SECs) at 1 month
Time frame: 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.
Standard Ethanol Content Units (SECs) at 3 month
Time frame: 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.
Peak SEC at Baseline
Time frame: 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.
Peak at 1 Month
Time frame: 30 days
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.
Peak at 3 Month
Time frame: 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.
Alcohol Drink Days at Baseline
Time frame: 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.
Alcohol Drink Days at 1 Month
Time frame: 30 days
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.
Alcohol Drink Days at 3 Month
Time frame: 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.
Binge Drink Days at Baseline
Time frame: 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.
Binge Drink Days at 1 month
Time frame: 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.
Binge Drink Days at 3 Month
Time frame: 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.
Illicit Drug Use Days at Baseline
Time frame: 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.
Illicit Drug Use Days at 1 Month
Time frame: 30 days
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.
Illicit Drug Use Days at 3 month
Time frame: 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.
Substance Use Disorder Treatment Sessions at Baseline
Time frame: 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.
Substance Use Disorder Treatment Sessions at 1 month
Time frame: 30 days
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.
Substance Use Disorder Treatment Sessions at 3 Month
Time frame: 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.
Twelve-Step Sessions Attended at Baseline
Time frame: Baseline
A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days prior to Baseline.
Twelve-Step Sessions Attended at 1 Month
Time frame: 30 days
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.
Twelve-Step Sessions Attended at 3 month
Time frame: 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.
Community Participation Activities at Baseline
Time frame: 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.
Community Participation Activities at 1 month
Time frame: 30 days
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.
Community Participation Activities at 3 month
Time frame: 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.
Mental Health Treatment Sessions at Baseline
Time frame: 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.
Mental Health Treatment Sessions at 1 month
Time frame: 30 days
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.
Mental Health Treatment Sessions at 3 month
Time frame: 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.
25 secondary outcomes
Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use
Time frame: Baseline
Addiction Severity Index-Lite (ASI-Lite) at 1 month for Alcohol Use
Time frame: 30 days
Addiction Severity Index-Lite (ASI-Lite) at 3 month for Alcohol Use
Time frame: 3 Month
Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status
Time frame: Baseline
Addiction Severity Index-Lite (ASI-Lite) at 1 month for Psychiatric Status
Time frame: 30 days
Addiction Severity Index-Lite (ASI-Lite) at 3 month for Psychiatric Status
Time frame: 3 Month
Short Inventory of Problems (SIP) at Baseline
Time frame: Baseline
Short Inventory of Problems (SIP) at 1 month
Time frame: 30 days
Short Inventory of Problems (SIP) at 3 month
Time frame: 3 Month
Quality of Life Survey (QOLS) at Baseline
Time frame: Baseline
Quality of Life Survey (QOLS) at 1 month
Time frame: 30 days
Quality of Life Survey (QOLS) at 3 month
Time frame: 3 Month
Brief Symptom Inventory (BSI-18) at Baseline
Time frame: Baseline
Brief Symptom Inventory (BSI-18) at 1 month
Time frame: 30 days
Brief Symptom Inventory (BSI-18) at 3 month
Time frame: 3 Month
Treatment Motivation Questionnaire (TMQ) at Baseline
Time frame: Baseline
Treatment Motivation Questionnaire (TMQ) at 1 month
Time frame: 30 days
Treatment Motivation Questionnaire (TMQ) at 3 month
Time frame: 3 Month
Fagerstrom Test for Nicotine Dependence at Baseline
Time frame: Baseline
Preventable Healthcare Services at 1 month Baseline
Time frame: 30 days
Preventable Healthcare Services at 1 month
Time frame: 30 days
Preventable Healthcare Services at 3 month
Time frame: 3 Month
Housing Status Inventory at Baseline
Time frame: Baseline
Housing Status Inventory at 1 month
Time frame: 30 days
Housing Status Inventory at 3 month
Time frame: 3 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J. Santa Ana, PhD MA BA principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Recovery Program and Stable & Able (S&A) in people with Alcoholism and Substance-related Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Ethanol Content Units (SECs) Baseline (time frame: Baseline). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.