- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02233738
Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29401-5703
- Ralph H. Johnson VA Medical Center, Charleston, SC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
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Active Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standard Ethanol Content Units (SECs) Baseline
Time Frame: 30 days prior to Baseline
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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.
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30 days prior to Baseline
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Standard Ethanol Content Units (SECs) at 1 Month
Time Frame: 1 month
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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.
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1 month
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Standard Ethanol Content Units (SECs) at 3 Months
Time Frame: 3 months
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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.
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3 months
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Standard Ethanol Content Units (SECs) at 6 Months
Time Frame: 6 months
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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.
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6 months
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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.
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30 days prior to Baseline
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Peak SEC at 1 Month
Time Frame: 1 month
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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.
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1 month
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Peak SEC at 3 Months
Time Frame: 3 months
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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.
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3 months
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Peak SEC at 6 Months
Time Frame: 6 months
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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.
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6 months
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Alcohol Drink Days at Baseline
Time Frame: 30 days prior to Baseline
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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.
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30 days prior to Baseline
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Alcohol Drink Days at 1 Month
Time Frame: 1 month
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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.
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1 month
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Alcohol Drink Days at 3 Months
Time Frame: 3 months
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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.
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3 months
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Alcohol Drink Days at 6 Months
Time Frame: 6 months
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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.
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6 months
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Binge Drink Days at Baseline
Time Frame: 30 days prior to Baseline
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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).
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30 days prior to Baseline
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Binge Drink Days at 1 Month
Time Frame: 1 month
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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.
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1 month
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Binge Drink Days at 3 Months
Time Frame: 3 months
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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.
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3 months
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Binge Drink Days at 6 Months
Time Frame: 6 months
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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.
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6 months
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Illicit Drug Use Days at Baseline
Time Frame: 30 days prior to Baseline
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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.
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30 days prior to Baseline
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Illicit Drug Use Days at 1 Month
Time Frame: 1 month
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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.
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1 month
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Illicit Drug Use Days at 3 Months
Time Frame: 3 months
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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.
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3 months
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Illicit Drug Use Days at 6 Months
Time Frame: 6 months
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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.
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6 months
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Substance Use Disorder Treatment Sessions at Baseline
Time Frame: 30 days prior to Baseline
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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.
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30 days prior to Baseline
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Substance Use Disorder Treatment Sessions at 1 Month
Time Frame: 1 month
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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.
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1 month
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Substance Use Disorder Treatment Sessions at 3 Months
Time Frame: 3 months
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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.
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3 months
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Substance Use Disorder Treatment Sessions at 6 Months
Time Frame: 6 months
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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.
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6 months
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Twelve-Step Sessions Attended at Baseline
Time Frame: 30 days prior to Baseline
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A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days prior to Baseline.
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30 days prior to Baseline
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Twelve-Step Sessions Attended at 1 Month
Time Frame: 1 month
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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.
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1 month
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Twelve-Step Sessions Attended at 3 Months
Time Frame: 3 months
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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.
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3 months
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Twelve-Step Sessions Attended at 6 Months
Time Frame: 6 months
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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.
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6 months
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Times Involved in Community Participation Activities at Baseline
Time Frame: 30 days prior to Baseline
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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.
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30 days prior to Baseline
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Times Involved in Community Participation Activities at 1 Month
Time Frame: 1 month
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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.
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1 month
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Times Involved in Community Participation Activities at 3 Months
Time Frame: 3 months
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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.
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3 months
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Times Involved in Community Participation Activities at 6 Months
Time Frame: 6 months
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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.
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6 months
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Days Involved in Productive Work Activities at Baseline
Time Frame: 30 days prior to Baseline
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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.
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30 days prior to Baseline
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Days Involved in Productive Work Activities at 1 Month
Time Frame: 1 month
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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.
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1 month
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Days Involved in Productive Work Activities at 3 Months
Time Frame: 3 months
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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
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3 months
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Days Involved in Productive Work Activities at 6 Months
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Health Treatment Sessions at Baseline
Time Frame: 30 days prior to Baseline
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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.
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30 days prior to Baseline
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Mental Health Treatment Sessions at 1 Month
Time Frame: 1 Month
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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.
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1 Month
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Mental Health Treatment Sessions at 3 Months
Time Frame: 3 Months
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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.
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3 Months
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Mental Health Treatment Sessions at 6 Months
Time Frame: 6 Months
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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.
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6 Months
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Substance Use Disorder and Mental Health Treatment Sessions at Baseline
Time Frame: 30 days prior to Baseline
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This specific measure combined the number substance use disorder treatment sessions and mental health treatment sessions attended for the 30 days prior to Baseline.
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30 days prior to Baseline
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Substance Use Disorder and Mental Health Treatment Sessions at 1 Month
Time Frame: 1 Month
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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.
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1 Month
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Substance Use Disorder and Mental Health Treatment Sessions at 3 Months
Time Frame: 3 Months
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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.
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3 Months
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Substance Use Disorder and Mental Health Treatment Sessions at 6 Months
Time Frame: 6 Months
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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.
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6 Months
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Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use
Time Frame: 30 days prior to Baseline
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The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
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30 days prior to Baseline
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Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Alcohol Use
Time Frame: 1 month
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The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
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1 month
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Addiction Severity Index-Lite (ASI-Lite) at 3 Months for Alcohol Use
Time Frame: 3 months
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The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
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3 months
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Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Alcohol Use
Time Frame: 6 months
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The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
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6 months
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Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status
Time Frame: 30 days prior to Baseline
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The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
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30 days prior to Baseline
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Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Psychiatric Status
Time Frame: 30 days
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The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
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30 days
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Addiction Severity Index-Lite (ASI-Lite) at 3 Month for Psychiatric Status
Time Frame: 3 months
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The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
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3 months
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Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Psychiatric Status
Time Frame: 6 months
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The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity
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6 months
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Short Inventory of Problems (SIP) at Baseline
Time Frame: 30 days prior to Baseline
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Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
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30 days prior to Baseline
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Short Inventory of Problems at 1 Month
Time Frame: 1 month
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Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
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1 month
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Short Inventory of Problems at 3 Months
Time Frame: 3 months
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Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
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3 months
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Short Inventory of Problems at 6 Months
Time Frame: 6 months
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Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use
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6 months
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Social Support Survey Total Score at Baseline
Time Frame: 30 days prior to Baseline
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Min value:19 Max value:95 Higher score indicates higher support
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30 days prior to Baseline
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Social Support Survey Total Score at 1 Month
Time Frame: 30 days prior to 1-month follow-up
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Min value:19 Max value:95 Higher score indicates higher support
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30 days prior to 1-month follow-up
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Social Support Survey Total Score at 3 Months
Time Frame: 60 days prior to 3-month follow-up
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Min value:19 Max value:95 Higher score indicates higher support
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60 days prior to 3-month follow-up
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Social Support Survey Total Score at 6 Months
Time Frame: 90 days prior to 6-month follow-up
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Min value:19 Max value:95 Higher score indicates higher support
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90 days prior to 6-month follow-up
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Quality of Life Survey (QOLS) at Baseline
Time Frame: 30 days prior to Baseline
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Min value:16 Max value:112 Higher score indicates higher quality of life
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30 days prior to Baseline
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Quality of Life Survey (QOLS) at 1 Month
Time Frame: 1 month
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Min value:16 Max value:112 Higher score indicates higher quality of life
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1 month
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Quality of Life Survey (QOLS) at 3 Months
Time Frame: 3 months
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Min value:16 Max value:112 Higher score indicates higher quality of life
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3 months
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Quality of Life Survey (QOLS) at 6 Months
Time Frame: 6 months
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Min value:16 Max value:112 Higher score indicates higher quality of life
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6 months
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Brief Symptom Inventory (BSI-18) at Baseline
Time Frame: 30 days prior to Baseline
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Min value:0 Max value:72 Higher score indicates higher psychological distress
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30 days prior to Baseline
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Brief Symptom Inventory(BSI-18) at 1 Month
Time Frame: 1 month
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Min value:0 Max value:72 Higher score indicates higher psychological distress
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1 month
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Brief Symptom Inventory (BSI-18) at 3 Months
Time Frame: 3 months
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Min value:0 Max value:72 Higher score indicates higher psychological distress
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3 months
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Brief Symptom Inventory (BSI-18) at 6 Months
Time Frame: 6 months
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Min value:0 Max value:72 Higher score indicates higher psychological distress
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6 months
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SF-12 Health Survey Physical Summary Score at Baseline
Time Frame: 30 days prior to Baseline
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Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
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30 days prior to Baseline
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SF-12 Health Survey Physical Summary Score at 1 Month
Time Frame: 1 month
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Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
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1 month
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SF-12 Health Survey Physical Summary Score at 3 Months
Time Frame: 3 months
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Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
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3 months
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SF-12 Health Survey Physical Summary Score at 6 Months
Time Frame: 6 months
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Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
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6 months
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SF-12 Health Survey Mental Summary Score at Baseline
Time Frame: 30 days prior to Baseline
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Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
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30 days prior to Baseline
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SF-12 Health Survey Mental Summary Score at 1 Month
Time Frame: 1 month
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Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
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1 month
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SF-12 Health Survey Mental Summary Score at 3 Months
Time Frame: 3 months
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Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
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3 months
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SF-12 Health Survey Mental Summary Score at 6 Months
Time Frame: 6 months
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Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health
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6 months
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Treatment Motivation Questionnaire (TMQ) at Baseline
Time Frame: 30 days prior to 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) |
30 days prior to Baseline
|
Treatment Motivation Questionnaire (TMQ) at 1-month
Time Frame: 30 days prior to 1-month follow-up
|
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) |
30 days prior to 1-month follow-up
|
Treatment Motivation Questionnaire (TMQ) at 3-month
Time Frame: 60 days prior to 3-month follow-up
|
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) |
60 days prior to 3-month follow-up
|
Treatment Motivation Questionnaire (TMQ) at 6-months
Time Frame: 90 days prior to 6-month follow-up
|
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) |
90 days prior to 6-month follow-up
|
Fagerstrom Test for Nicotine Dependence at Baseline
Time Frame: 30 days prior to Baseline
|
Min:0 Max:10 Higher score indicates higher level of nicotine dependence
|
30 days prior to Baseline
|
Psychiatric Outpatient Satisfaction Scale - Total Score
Time Frame: 1 month
|
Min:13 Max:65 Higher score indicates better satisfaction
|
1 month
|
Helping Alliance Questionnaire - Total Score
Time Frame: Completed during session 4 of treatment group (i.e. the final treatment session)
|
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 |
Completed during session 4 of treatment group (i.e. the final treatment session)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth J. Santa Ana, PhD MA BA, Ralph H. Johnson VA Medical Center, Charleston, SC
Publications and helpful links
General 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.
- Gebregziabher 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.
- Shorey 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.
- Santa 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 13-317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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