AlcoholismNCT02233738
Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
A study testing Group Motivational Interviewing (GMI) in people with Alcoholism and Substance-related Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Homeless Veterans with substance use disorders (SUDs) are a major group served by VA and are heavily represented in VA housing. VA recently adopted a 'Housing First' approach emphasizing rapid housing placement to initiate recovery without requiring sobriety and will necessitate SUD interventions that are efficient… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcoholism, Substance-related Disorders, Dual Diagnosis
- What is being tested?
- Group Motivational Interviewing (GMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2015to 17 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women Veterans currently in Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]), newly entering the program but not yet housed, or Veterans on the HUD-VASH interest (wait) list.
- Able to comprehend English.
- Meets DSM-V criteria for a current substance use disorder and have used substances in the 30 days prior to treatment entry. Participants on medications targeting their substance use must be stabilized on medications for at least 2 weeks before therapy initiation.
- May meet criteria a mood, anxiety or other psychiatric disorder. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation.
- Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Willing to commit to 4 group therapy sessions, baseline, 1, 3, and 6 month follow-up assessments.
Who cannot join
- Active suicidal or homicidal ideation with a plan as this is likely to require hospitalization or other interventions that could interfere with study participation.
- Unstable psychiatric condition that is likely to require hospitalization or other interventions that would interfere with study participation.
- Unstable medical condition or one that may require hospitalization during the course of the study.
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
Homeless Veterans with substance use disorders (SUDs) are a major group served by VA and are heavily represented in VA housing. VA recently adopted a 'Housing First' approach emphasizing rapid housing placement to initiate recovery without requiring sobriety and will necessitate SUD interventions that are efficient and easily layered onto existing services. The proposed study will investigate the effectiveness, implementation process, and cost estimate of Group Motivational Interviewing (GMI) for Veterans with SUDs in VA housing (Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]). Outcomes will be assessed at multiple time points using a multi-modal approach. The ultimate goal of this research is to establish the basis of a GMI dissemination and implementation course of action for highly vulnerable homeless Veterans in VA housing for achieving their greatest success in attaining housing stability.
Read the detailed description
Anticipated Impacts on Veterans Health Care:
VA set an ambitious goal for ending homelessness among Veterans by 2015. Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD] are two primary VA housing programs to help Veterans exit homelessness. Substance abuse among Veterans in VA housing is a major risk factor for worsening psychopathology and housing instability. Despite recent adoption of a Housing First approach, many VA housing programs lack the staff infrastructure to manage substance use disorders (SUDs). This is a significant problem as 60% (conservative estimate) of Veterans in VA housing have SUDs and these Veterans show greater psychopathology compared to their counterparts without SUDs. These issues warrant substantial need for SUD programs in VA housing that are efficient to deploy, easily layered onto existing services, and require minimal staff to operate. The current study addresses this current void in VA treatment services in that it investigates the effectiveness, implementation process, and cost estimate of treatment of an adaptation of motivational interviewing, an empirically supported intervention with strong impact on reducing substance use and enhancing treatment engagement, in a group format, referred to as Group Motivational Interviewing (GMI) for Veterans with SUDs in VA housing. Data from this project, if shown to be promising, will establish the basis of a GMI dissemination and implementation course of action for highly vulnerable homeless Veterans in VA housing for achieving their greatest success in attaining housing stability.
Background:
There is a significant need for 'wraparound' treatment services in VA housing for addressing SUDs. Homeless Veterans with SUDs are vulnerable to treatment dropout, rendering them susceptible to relapse, while their continuation in outpatient care during their participation in VA housing leads to improved clinical outcomes. According to systematic reviews, individual motivational interviewing reduces the incidence of substance use disorders, when compared to no treatment, but is labor intensive. As VA moves toward a 'Housing First' paradigm where greater numbers of homeless Veterans will continue to use substances while in VA housing, delivery of GMI (which may be less labor intensive) to these patients will be important for initiating and maintaining their recovery as well as enhancing their psychosocial integration and quality of life. In a prior controlled trial conducted by the Principal Investigator, GMI resulted in significantly higher outpatient treatment engagement and lower substance use compared to treatment-as-usual among dually diagnosed Veterans.
Objectives:
Study objectives are consistent with VA housing recommendations focusing on patient recovery, health services promotion, and treatment implementation evaluation. GMI will be compared to a control treatment condition (CT) on (Specific Aim I; Five outcomes: (Primary Hypothesis 1): treatment engagement; (Primary Hypothesis 1): substance use; (Secondary H2): psychosocial integration (e.g., social support, community participation); (Secondary H3) quality of life/psychiatric indices; and (Secondary H4): number of days engaging in structured/productive work activities in the 6-month follow up. Specific Aim II involves a process evaluation for documenting (A) formative (e.g., developmental), (B) process, and (C) summative outcomes; and Specific Aim III involves estimation of cost of intervention in terms of direct costs, indirect costs of staff, costs of capital and workload measures for future implementation and dissemination research.
Methods:
Randomized controlled trial comparing GMI to control treatment (CT) across five critical outcomes. 186 Veterans in VA housing services (93 per treatment arm) will be enrolled with a diagnosis of alcohol or drug abuse/dependence. Recruitment will take place in Charleston VA Medical Center HUD-VASH \& GPD. Participants will be randomly assigned to (1) GMI or (2) CT, each consisting of 4 sessions, and will be evaluated at 1, 3, and 6 months. Participants with a non-substance related DSM-V disorder (e.g., major depressive disorder, PTSD) will be eligible for the study. Analyses will be conducted using generalized linear mixed models (GLMM) approach.
Significance to Veterans:
Homeless Veterans with SUDs represent one of the largest and most chronic groups of psychiatric patients treated in the VA Healthcare System. With the ongoing execution of VA's "Plan to End Veteran Homelessness," Veterans entering housing require interventions that can be feasibly implemented with minimal reorganization of existing services. GMI is based on motivational interviewing, an empirically valid treatment that aligns with Veteran-centered recovery models including Harm Reduction and more traditional treatment philosophies. The investment in GMI for VA housing may be minimal as it requires only a few staff to operate in relatively short time (e.g., 4 sessions, 90-min each) with modest (20 hours) staff training. It can be layered onto existing services with little interruption or reorganization of staff, and it has potential to be offered to larger numbers of Veterans with SUDs in VA housing who would otherwise not receive this intervention.
- Conditions
- Alcoholism, Substance-related Disorders, Dual Diagnosis
- Being tested
- Group Motivational Interviewing (GMI), Control Treatment Condition (CT)
- 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.
Group Motivational Interviewing (GMI)Behavioural
Participants randomized to Group Motivational Interviewing (GMI) will receive four structured, back-to-back, 90-minute sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both.
Control Treatment Condition (CT)Behavioural
Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to GMI (i.e., 90 minutes) and will involve the following topics: A popular 'box activity': participants will anonymously write evocative questions on slips of paper involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion (e.g., "How do I talk to my family about my alcohol problem?"), money management with feedback (2 sessions), and cooking-home maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Group Motivational Interviewing (GMI) | Experimental | Group Motivational Interviewing (GMI) participants will receive four structured, back-to-back, 90-min sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both. Receives: Behavioral: Group Motivational Interviewing (GMI) |
| Control Treatment Condition (CT) | Active comparator | Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to Group Motivational Interviewing (GMI) (i.e., 90 minutes) and will involve the following topics: A popular 'box activity': participants will anonymously write evocative questions on slips of paper involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion (e.g., "How do I talk to my family about my alcohol problem?"), money management with feedback (2 sessions), and cooking-home maintenance. Receives: Behavioral: Control Treatment Condition (CT) |
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 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 ALL standard drinks consumed within the stated time period.
Measured: 30 days prior to Baseline
Standard Ethanol Content Units (SECs) at 1 Month
The 1-month follow-up was conducted 30 days after day 1 of the treatment group. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 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: 1 month
Standard Ethanol Content Units (SECs) at 3 Months
The 3-month follow-up was conducted 60 days after the 1-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-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 months
Standard Ethanol Content Units (SECs) at 6 Months
The 6-month follow-up was conducted 90 days after the 3-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-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: 6 months
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: 30 days prior to Baseline
Peak SEC at 1 Month
The 1-month follow-up was conducted 30 days after day 1 of the treatment group. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 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 on a single day within the stated time period.
Measured: 1 month
Peak SEC at 3 Months
The 3-month follow-up was conducted 60 days after the 1-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-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 on a single day within the stated time period.
Measured: 3 months
Peak SEC at 6 Months
The 6-month follow-up was conducted 90 days after the 3-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-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 on a single day within the stated time period.
Measured: 6 months
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: 30 days prior to 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 day 1 of the treatment group. This measure represents the number of days any alcohol was consumed within the stated time period.
Measured: 1 month
Alcohol Drink Days at 3 Months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of days any alcohol was consumed within the stated time period.
Measured: 3 months
Alcohol Drink Days at 6 Months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of days any alcohol was consumed within the stated time period.
Measured: 6 months
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 (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females).
Measured: 30 days prior to 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 prior to 1-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.
Measured: 1 month
Binge Drink Days at 3 Months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.
Measured: 3 months
Binge Drink Days at 6 Months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.
Measured: 6 months
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: 30 days prior to Baseline
Illicit Drug Use Days at 1 Month
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. This measure represents the number of illicit drug use days within the stated time period.
Measured: 1 month
Illicit Drug Use Days at 3 Months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of illicit drug use days within the stated time period.
Measured: 3 months
Illicit Drug Use Days at 6 Months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of illicit drug use days within the stated time period.
Measured: 6 months
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 Computerized Patient Record System for the 30 days prior to Baseline. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.
Measured: 30 days prior to 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 Computerized Patient Record System for the 30 days prior to 1-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.
Measured: 1 month
Substance Use Disorder Treatment Sessions at 3 Months
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 prior to 3-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.
Measured: 3 months
Substance Use Disorder Treatment Sessions at 6 Months
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 prior to 6-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.
Measured: 6 months
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: 30 days prior to 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 prior to 1-month follow-up.
Measured: 1 month
Twelve-Step Sessions Attended at 3 Months
A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 60 days prior to 3-month follow-up.
Measured: 3 months
Twelve-Step Sessions Attended at 6 Months
A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended in the 90 days prior to 6-month follow-up.
Measured: 6 months
Times Involved in 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: 30 days prior to Baseline
Times Involved in 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 prior to 1-month follow-up.
Measured: 1 month
Times Involved in Community Participation Activities at 3 Months
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 prior to 3-month follow-up.
Measured: 3 months
Times Involved in Community Participation Activities at 6 Months
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 90 days prior to 6-month follow-up.
Measured: 6 months
Days Involved in Productive Work Activities at Baseline
A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 30 days prior to Baseline.
Measured: 30 days prior to Baseline
Days Involved in Productive Work Activities at 1 Month
A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 30 days prior to 1-month follow-up.
Measured: 1 month
Days Involved in Productive Work Activities at 3 Months
A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 60 days prior to 3-month follow-up
Measured: 3 months
Days Involved in Productive Work Activities at 6 Months
A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 90 days prior to 6-month follow-up.
Measured: 6 months
Secondary outcomes (47)
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: 30 days prior to 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 prior to 1-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.
Measured: 1 Month
Mental Health Treatment Sessions at 3 Months
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 prior to 3-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.
Measured: 3 Months
Mental Health Treatment Sessions at 6 Months
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 90 days prior to 6-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.
Measured: 6 Months
Substance Use Disorder and Mental Health Treatment Sessions at Baseline
This specific measure combined the number substance use disorder treatment sessions and mental health treatment sessions attended for the 30 days prior to Baseline.
Measured: 30 days prior to Baseline
Substance Use Disorder and Mental Health Treatment Sessions at 1 Month
This specific measure combined the number substance use disorder treatment sessions and mental health treatment sessions attended for the 30 days prior to 1-month follow-up.
Measured: 1 Month
Substance Use Disorder and Mental Health Treatment Sessions at 3 Months
This specific measure combined the number substance use disorder treatment sessions and mental health treatment sessions attended for the 60 days prior to 3-month follow-up.
Measured: 3 Months
Substance Use Disorder and Mental Health Treatment Sessions at 6 Months
This specific measure combined the number substance use disorder treatment sessions and mental health treatment sessions attended for the 90 days prior to 6-month follow-up.
Measured: 6 Months
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: 30 days prior to 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: 1 month
Addiction Severity Index-Lite (ASI-Lite) at 3 Months 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 months
Addiction Severity Index-Lite (ASI-Lite) at 6 Months 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: 6 months
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: 30 days prior to 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 months
Addiction Severity Index-Lite (ASI-Lite) at 6 Months 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: 6 months
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: 30 days prior to Baseline
Short Inventory of Problems at 1 Month
Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
Measured: 1 month
Short Inventory of Problems at 3 Months
Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
Measured: 3 months
Short Inventory of Problems at 6 Months
Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
Measured: 6 months
Social Support Survey Total Score at Baseline
Min value:19 Max value:95 Higher score indicates higher support
Measured: 30 days prior to Baseline
Social Support Survey Total Score at 1 Month
Min value:19 Max value:95 Higher score indicates higher support
Measured: 30 days prior to 1-month follow-up
Social Support Survey Total Score at 3 Months
Min value:19 Max value:95 Higher score indicates higher support
Measured: 60 days prior to 3-month follow-up
Social Support Survey Total Score at 6 Months
Min value:19 Max value:95 Higher score indicates higher support
Measured: 90 days prior to 6-month follow-up
Quality of Life Survey (QOLS) at Baseline
Min value:16 Max value:112 Higher score indicates higher quality of life
Measured: 30 days prior to Baseline
Quality of Life Survey (QOLS) at 1 Month
Min value:16 Max value:112 Higher score indicates higher quality of life
Measured: 1 month
Quality of Life Survey (QOLS) at 3 Months
Min value:16 Max value:112 Higher score indicates higher quality of life
Measured: 3 months
Quality of Life Survey (QOLS) at 6 Months
Min value:16 Max value:112 Higher score indicates higher quality of life
Measured: 6 months
Brief Symptom Inventory (BSI-18) at Baseline
Min value:0 Max value:72 Higher score indicates higher psychological distress
Measured: 30 days prior to Baseline
Brief Symptom Inventory(BSI-18) at 1 Month
Min value:0 Max value:72 Higher score indicates higher psychological distress
Measured: 1 month
Brief Symptom Inventory (BSI-18) at 3 Months
Min value:0 Max value:72 Higher score indicates higher psychological distress
Measured: 3 months
Brief Symptom Inventory (BSI-18) at 6 Months
Min value:0 Max value:72 Higher score indicates higher psychological distress
Measured: 6 months
SF-12 Health Survey Physical Summary Score at Baseline
Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
Measured: 30 days prior to Baseline
SF-12 Health Survey Physical Summary Score at 1 Month
Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
Measured: 1 month
SF-12 Health Survey Physical Summary Score at 3 Months
Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
Measured: 3 months
SF-12 Health Survey Physical Summary Score at 6 Months
Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
Measured: 6 months
SF-12 Health Survey Mental Summary Score at Baseline
Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
Measured: 30 days prior to Baseline
SF-12 Health Survey Mental Summary Score at 1 Month
Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
Measured: 1 month
SF-12 Health Survey Mental Summary Score at 3 Months
Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
Measured: 3 months
SF-12 Health Survey Mental Summary Score at 6 Months
Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
Measured: 6 months
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: 30 days prior to 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 prior to 1-month follow-up
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: 60 days prior to 3-month follow-up
Treatment Motivation Questionnaire (TMQ) at 6-months
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: 90 days prior to 6-month follow-up
Fagerstrom Test for Nicotine Dependence at Baseline
Min:0 Max:10 Higher score indicates higher level of nicotine dependence
Measured: 30 days prior to Baseline
Psychiatric Outpatient Satisfaction Scale - Total Score
Min:13 Max:65 Higher score indicates better satisfaction
Measured: 1 month
Helping Alliance Questionnaire - Total Score
Participant completed assessment on the final day of group and rated therapist based on their interactions over the 4 days.
Min:19 Max:114 Higher score indicates stronger alliance with therapist
Measured: Completed during session 4 of treatment group (i.e. the final treatment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study start30 Sep 2015
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 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
- NCT02233738
- Sponsor's protocol ID
- IIR 13-317
- Status last verified
- Jul 2023
- First submitted
- 21 Aug 2014
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaconis M, Santa Ana EJ, Killeen TK, Badour CL, Back SE. Concurrent treatment of PTSD and alcohol use disorder via telehealth in a female Iraq veteran. Am J Addict. 2017 Mar;26(2):112-114. doi: 10.1111/ajad.12481. Epub 2017 Jan 24.
PubMed 28118514Gebregziabher M, Voronca D, Teklehaimanot A, Santa Ana EJ. Weibull mixture regression for marginal inference in zero-heavy continuous outcomes. Stat Methods Med Res. 2017 Jun;26(3):1476-1499. doi: 10.1177/0962280215583402. Epub 2015 Apr 22.
PubMed 25902801Shorey RC, Martino S, Lamb KE, LaRowe SD, Santa Ana EJ. Change talk and relatedness in group motivational interviewing: a pilot study. J Subst Abuse Treat. 2015 Apr;51:75-81. doi: 10.1016/j.jsat.2014.11.003. Epub 2014 Nov 20.
PubMed 25488505Santa Ana EJ, LaRowe SD, Armeson K, Lamb KE, Hartwell K. Impact of group motivational interviewing on enhancing treatment engagement for homeless Veterans with nicotine dependence and other substance use disorders: A pilot investigation. Am J Addict. 2016 Oct;25(7):533-41. doi: 10.1111/ajad.12426. Epub 2016 Sep 2.
PubMed 27589072
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
- ClinicalTrials.gov ID
- NCT02233738
- Acronym / sponsor ID
- IIR 13-317
- Conditions
- Alcoholism, Substance-related Disorders, Dual Diagnosis
- Keywords
- Alcoholism, Substance-related disorders, Dual Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Posted 16 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Homeless Veterans with substance use disorders (SUDs) are a major group served by VA and are heavily represented in VA housing. VA recently adopted a 'Housing First' approach emphasizing rapid housing placement to initiate recovery without requiring sobriety and will necessitate SUD interventions that are efficient and easily layered onto existing services. The proposed study will investigate the effectiveness, implementation process, and cost estimate of Group Motivational Interviewing (GMI) for Veterans with SUDs in VA housing (Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]). Outcomes will be assessed at multiple time points using a multi-modal approach. The ultimate goal of this research is to establish the basis of a GMI dissemination and implementation course of action for highly vulnerable homeless Veterans in VA housing for achieving their greatest success in attaining housing stability.
Detailed description
Anticipated Impacts on Veterans Health Care:
VA set an ambitious goal for ending homelessness among Veterans by 2015. Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD] are two primary VA housing programs to help Veterans exit homelessness. Substance abuse among Veterans in VA housing is a major risk factor for worsening psychopathology and housing instability. Despite recent adoption of a Housing First approach, many VA housing programs lack the staff infrastructure to manage substance use disorders (SUDs). This is a significant problem as 60% (conservative estimate) of Veterans in VA housing have SUDs and these Veterans show greater psychopathology compared to their counterparts without SUDs. These issues warrant substantial need for SUD programs in VA housing that are efficient to deploy, easily layered onto existing services, and require minimal staff to operate. The current study addresses this current void in VA treatment services in that it investigates the effectiveness, implementation process, and cost estimate of treatment of an adaptation of motivational interviewing, an empirically supported intervention with strong impact on reducing substance use and enhancing treatment engagement, in a group format, referred to as Group Motivational Interviewing (GMI) for Veterans with SUDs in VA housing. Data from this project, if shown to be promising, will establish the basis of a GMI dissemination and implementation course of action for highly vulnerable homeless Veterans in VA housing for achieving their greatest success in attaining housing stability.
Background:
There is a significant need for 'wraparound' treatment services in VA housing for addressing SUDs. Homeless Veterans with SUDs are vulnerable to treatment dropout, rendering them susceptible to relapse, while their continuation in outpatient care during their participation in VA housing leads to improved clinical outcomes. According to systematic reviews, individual motivational interviewing reduces the incidence of substance use disorders, when compared to no treatment, but is labor intensive. As VA moves toward a 'Housing First' paradigm where greater numbers of homeless Veterans will continue to use substances while in VA housing, delivery of GMI (which may be less labor intensive) to these patients will be important for initiating and maintaining their recovery as well as enhancing their psychosocial integration and quality of life. In a prior controlled trial conducted by the Principal Investigator, GMI resulted in significantly higher outpatient treatment engagement and lower substance use compared to treatment-as-usual among dually diagnosed Veterans.
Objectives:
Study objectives are consistent with VA housing recommendations focusing on patient recovery, health services promotion, and treatment implementation evaluation. GMI will be compared to a control treatment condition (CT) on (Specific Aim I; Five outcomes: (Primary Hypothesis 1): treatment engagement; (Primary Hypothesis 1): substance use; (Secondary H2): psychosocial integration (e.g., social support, community participation); (Secondary H3) quality of life/psychiatric indices; and (Secondary H4): number of days engaging in structured/productive work activities in the 6-month follow up. Specific Aim II involves a process evaluation for documenting (A) formative (e.g., developmental), (B) process, and (C) summative outcomes; and Specific Aim III involves estimation of cost of intervention in terms of direct costs, indirect costs of staff, costs of capital and workload measures for future implementation and dissemination research.
Methods:
Randomized controlled trial comparing GMI to control treatment (CT) across five critical outcomes. 186 Veterans in VA housing services (93 per treatment arm) will be enrolled with a diagnosis of alcohol or drug abuse/dependence. Recruitment will take place in Charleston VA Medical Center HUD-VASH \& GPD. Participants will be randomly assigned to (1) GMI or (2) CT, each consisting of 4 sessions, and will be evaluated at 1, 3, and 6 months. Participants with a non-substance related DSM-V disorder (e.g., major depressive disorder, PTSD) will be eligible for the study. Analyses will be conducted using generalized linear mixed models (GLMM) approach.
Significance to Veterans:
Homeless Veterans with SUDs represent one of the largest and most chronic groups of psychiatric patients treated in the VA Healthcare System. With the ongoing execution of VA's "Plan to End Veteran Homelessness," Veterans entering housing require interventions that can be feasibly implemented with minimal reorganization of existing services. GMI is based on motivational interviewing, an empirically valid treatment that aligns with Veteran-centered recovery models including Harm Reduction and more traditional treatment philosophies. The investment in GMI for VA housing may be minimal as it requires only a few staff to operate in relatively short time (e.g., 4 sessions, 90-min each) with modest (20 hours) staff training. It can be layered onto existing services with little interruption or reorganization of staff, and it has potential to be offered to larger numbers of Veterans with SUDs in VA housing who would otherwise not receive this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Motivational Interviewing (GMI) | Experimental | Behavioral: Group Motivational Interviewing (GMI)Group Motivational Interviewing (GMI) participants will receive four structured, back-to-back, 90-min sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both. |
| Control Treatment Condition (CT) | Active comparator | Behavioral: Control Treatment Condition (CT)Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to Group Motivational Interviewing (GMI) (i.e., 90 minutes) and will involve the following topics: A popular 'box activity': participants will anonymously write evocative questions on slips of paper involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion (e.g., "How do I talk to my family about my alcohol problem?"), money management with feedback (2 sessions), and cooking-home maintenance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women Veterans currently in Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]), newly entering the program but not yet housed, or Veterans on the HUD-VASH interest (wait) list.
- Able to comprehend English.
- Meets DSM-V criteria for a current substance use disorder and have used substances in the 30 days prior to treatment entry. Participants on medications targeting their substance use must be stabilized on medications for at least 2 weeks before therapy initiation.
- May meet criteria a mood, anxiety or other psychiatric disorder. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation.
- Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Key exclusion criteria (3 listed)
- Active suicidal or homicidal ideation with a plan as this is likely to require hospitalization or other interventions that could interfere with study participation.
- Unstable psychiatric condition that is likely to require hospitalization or other interventions that would interfere with study participation.
- Unstable medical condition or one that may require hospitalization during the course of the study.
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 |
|---|---|---|
| Group Motivational Interviewing (GMI)Participants randomized to Group Motivational Interviewing (GMI) will receive four structured, back-to-back, 90-minute sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both. | Behavioural | Group Motivational Interviewing (GMI) |
| Control Treatment Condition (CT)Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to GMI (i.e., 90 minutes) and will involve the following topics: A popular 'box activity': participants will anonymously write evocative questions on slips of paper involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion (e.g., "How do I talk to my family about my alcohol problem?"), money management with feedback (2 sessions), and cooking-home maintenance. | Behavioural | Control Treatment Condition (CT) |
Primary outcome
Standard Ethanol Content Units (SECs) Baseline
Time frame: 30 days prior to 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 ALL standard drinks consumed within the stated time period.
Standard Ethanol Content Units (SECs) at 1 Month
Time frame: 1 month
The 1-month follow-up was conducted 30 days after day 1 of the treatment group. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 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.
Standard Ethanol Content Units (SECs) at 3 Months
Time frame: 3 months
The 3-month follow-up was conducted 60 days after the 1-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-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.
Standard Ethanol Content Units (SECs) at 6 Months
Time frame: 6 months
The 6-month follow-up was conducted 90 days after the 3-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-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: 30 days prior to 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 SEC at 1 Month
Time frame: 1 month
The 1-month follow-up was conducted 30 days after day 1 of the treatment group. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 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 on a single day within the stated time period.
Peak SEC at 3 Months
Time frame: 3 months
The 3-month follow-up was conducted 60 days after the 1-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-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 on a single day within the stated time period.
Peak SEC at 6 Months
Time frame: 6 months
The 6-month follow-up was conducted 90 days after the 3-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-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 on a single day within the stated time period.
Alcohol Drink Days at Baseline
Time frame: 30 days prior to 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: 1 month
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after day 1 of the treatment group. This measure represents the number of days any alcohol was consumed within the stated time period.
Alcohol Drink Days at 3 Months
Time frame: 3 months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of days any alcohol was consumed within the stated time period.
Alcohol Drink Days at 6 Months
Time frame: 6 months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-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: 30 days prior to 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 (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females).
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 prior to 1-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.
Binge Drink Days at 3 Months
Time frame: 3 months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.
Binge Drink Days at 6 Months
Time frame: 6 months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.
Illicit Drug Use Days at Baseline
Time frame: 30 days prior to 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: 1 month
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. This measure represents the number of illicit drug use days within the stated time period.
Illicit Drug Use Days at 3 Months
Time frame: 3 months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of illicit drug use days within the stated time period.
Illicit Drug Use Days at 6 Months
Time frame: 6 months
The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-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: 30 days prior to 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 the outpatient substance use disorder treatment group sessions and individual sessions.
Substance Use Disorder Treatment Sessions at 1 Month
Time frame: 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 prior to 1-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.
Substance Use Disorder Treatment Sessions at 3 Months
Time frame: 3 months
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 prior to 3-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.
Substance Use Disorder Treatment Sessions at 6 Months
Time frame: 6 months
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 prior to 6-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: 30 days prior to 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: 1 month
A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days prior to 1-month follow-up.
Twelve-Step Sessions Attended at 3 Months
Time frame: 3 months
A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 60 days prior to 3-month follow-up.
Twelve-Step Sessions Attended at 6 Months
Time frame: 6 months
A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended in the 90 days prior to 6-month follow-up.
Times Involved in Community Participation Activities at Baseline
Time frame: 30 days prior to 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.
Times Involved in Community Participation Activities at 1 Month
Time frame: 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 prior to 1-month follow-up.
Times Involved in Community Participation Activities at 3 Months
Time frame: 3 months
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 prior to 3-month follow-up.
Times Involved in Community Participation Activities at 6 Months
Time frame: 6 months
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 90 days prior to 6-month follow-up.
Days Involved in Productive Work Activities at Baseline
Time frame: 30 days prior to Baseline
A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 30 days prior to Baseline.
Days Involved in Productive Work Activities at 1 Month
Time frame: 1 month
A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 30 days prior to 1-month follow-up.
Days Involved in Productive Work Activities at 3 Months
Time frame: 3 months
A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 60 days prior to 3-month follow-up
Days Involved in Productive Work Activities at 6 Months
Time frame: 6 months
A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 90 days prior to 6-month follow-up.
47 secondary outcomes
Mental Health Treatment Sessions at Baseline
Time frame: 30 days prior to Baseline
Mental Health Treatment Sessions at 1 Month
Time frame: 1 Month
Mental Health Treatment Sessions at 3 Months
Time frame: 3 Months
Mental Health Treatment Sessions at 6 Months
Time frame: 6 Months
Substance Use Disorder and Mental Health Treatment Sessions at Baseline
Time frame: 30 days prior to Baseline
Substance Use Disorder and Mental Health Treatment Sessions at 1 Month
Time frame: 1 Month
Substance Use Disorder and Mental Health Treatment Sessions at 3 Months
Time frame: 3 Months
Substance Use Disorder and Mental Health Treatment Sessions at 6 Months
Time frame: 6 Months
Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use
Time frame: 30 days prior to Baseline
Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Alcohol Use
Time frame: 1 month
Addiction Severity Index-Lite (ASI-Lite) at 3 Months for Alcohol Use
Time frame: 3 months
Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Alcohol Use
Time frame: 6 months
Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status
Time frame: 30 days prior to 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 months
Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Psychiatric Status
Time frame: 6 months
Short Inventory of Problems (SIP) at Baseline
Time frame: 30 days prior to Baseline
Short Inventory of Problems at 1 Month
Time frame: 1 month
Short Inventory of Problems at 3 Months
Time frame: 3 months
Short Inventory of Problems at 6 Months
Time frame: 6 months
Social Support Survey Total Score at Baseline
Time frame: 30 days prior to Baseline
Social Support Survey Total Score at 1 Month
Time frame: 30 days prior to 1-month follow-up
Social Support Survey Total Score at 3 Months
Time frame: 60 days prior to 3-month follow-up
Social Support Survey Total Score at 6 Months
Time frame: 90 days prior to 6-month follow-up
Quality of Life Survey (QOLS) at Baseline
Time frame: 30 days prior to Baseline
Quality of Life Survey (QOLS) at 1 Month
Time frame: 1 month
Quality of Life Survey (QOLS) at 3 Months
Time frame: 3 months
Quality of Life Survey (QOLS) at 6 Months
Time frame: 6 months
Brief Symptom Inventory (BSI-18) at Baseline
Time frame: 30 days prior to Baseline
Brief Symptom Inventory(BSI-18) at 1 Month
Time frame: 1 month
Brief Symptom Inventory (BSI-18) at 3 Months
Time frame: 3 months
Brief Symptom Inventory (BSI-18) at 6 Months
Time frame: 6 months
SF-12 Health Survey Physical Summary Score at Baseline
Time frame: 30 days prior to Baseline
SF-12 Health Survey Physical Summary Score at 1 Month
Time frame: 1 month
SF-12 Health Survey Physical Summary Score at 3 Months
Time frame: 3 months
SF-12 Health Survey Physical Summary Score at 6 Months
Time frame: 6 months
SF-12 Health Survey Mental Summary Score at Baseline
Time frame: 30 days prior to Baseline
SF-12 Health Survey Mental Summary Score at 1 Month
Time frame: 1 month
SF-12 Health Survey Mental Summary Score at 3 Months
Time frame: 3 months
SF-12 Health Survey Mental Summary Score at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28118514Jaconis M, Santa Ana EJ, Killeen TK, Badour CL, Back SE. Concurrent treatment of PTSD and alcohol use disorder via telehealth in a female Iraq veteran. Am J Addict. 2017 Mar;26(2):112-114. doi: 10.1111/ajad.12481. Epub 2017 Jan 24.
- Results publication: PubMed 25902801Gebregziabher M, Voronca D, Teklehaimanot A, Santa Ana EJ. Weibull mixture regression for marginal inference in zero-heavy continuous outcomes. Stat Methods Med Res. 2017 Jun;26(3):1476-1499. doi: 10.1177/0962280215583402. Epub 2015 Apr 22.
- Results publication: PubMed 25488505Shorey RC, Martino S, Lamb KE, LaRowe SD, Santa Ana EJ. Change talk and relatedness in group motivational interviewing: a pilot study. J Subst Abuse Treat. 2015 Apr;51:75-81. doi: 10.1016/j.jsat.2014.11.003. Epub 2014 Nov 20.
- Results publication: PubMed 27589072Santa Ana EJ, LaRowe SD, Armeson K, Lamb KE, Hartwell K. Impact of group motivational interviewing on enhancing treatment engagement for homeless Veterans with nicotine dependence and other substance use disorders: A pilot investigation. Am J Addict. 2016 Oct;25(7):533-41. doi: 10.1111/ajad.12426. Epub 2016 Sep 2.
- 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 Group Motivational Interviewing (GMI) 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: finished, as of the sponsor's last update on 27 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 30 days prior to Baseline). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233738, which also lists 4 linked publications.
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 27 Jul 2023.