Alcoholism, Dual Diagnosis, Substance-related Disorders
Conditions
Keywords
Alcoholism, Substance-related disorders, Dual Diagnosis
Brief 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 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.
Interventions
BEHAVIORALGroup 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.
BEHAVIORALControl 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak SEC at 1 Month | 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. |
| Standard Ethanol Content Units (SECs) Baseline | 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 | 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 | 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 | 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 | 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 3 Months | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-12 Health Survey Mental Summary Score at Baseline | 30 days prior to Baseline | Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health |
| SF-12 Health Survey Mental Summary Score at 1 Month | 1 month | Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health |
| SF-12 Health Survey Mental Summary Score at 3 Months | 3 months | Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health |
| SF-12 Health Survey Mental Summary Score at 6 Months | 6 months | Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health |
| Treatment Motivation Questionnaire (TMQ) at Baseline | 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) |
| Mental Health Treatment Sessions at Baseline | 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 individual sessions with outpatient mental health staff. |
| Treatment Motivation Questionnaire (TMQ) at 3-month | 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) |
| Treatment Motivation Questionnaire (TMQ) at 6-months | 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) |
| Fagerstrom Test for Nicotine Dependence at Baseline | 30 days prior to Baseline | Min:0 Max:10 Higher score indicates higher level of nicotine dependence |
| Psychiatric Outpatient Satisfaction Scale - Total Score | 1 month | Min:13 Max:65 Higher score indicates better satisfaction |
| Helping Alliance Questionnaire - Total Score | 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 |
| Treatment Motivation Questionnaire (TMQ) at 1-month | 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) |
| Mental Health Treatment Sessions at 1 Month | 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. |
| Mental Health Treatment Sessions at 3 Months | 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. |
| Mental Health Treatment Sessions at 6 Months | 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. |
| Substance Use Disorder and Mental Health Treatment Sessions at Baseline | 30 days prior to 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. |
| Substance Use Disorder and Mental Health Treatment Sessions at 1 Month | 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. |
| Substance Use Disorder and Mental Health Treatment Sessions at 3 Months | 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. |
| Substance Use Disorder and Mental Health Treatment Sessions at 6 Months | 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. |
| Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use | 30 days prior to Baseline | The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity |
| Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Alcohol Use | 1 month | The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity |
| Addiction Severity Index-Lite (ASI-Lite) at 3 Months for Alcohol Use | 3 months | The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity |
| Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Alcohol Use | 6 months | The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity |
| Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status | 30 days prior to Baseline | The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity |
| Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Psychiatric Status | 30 days | The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity |
| Addiction Severity Index-Lite (ASI-Lite) at 3 Month for Psychiatric Status | 3 months | The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity |
| Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Psychiatric Status | 6 months | The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity |
| Short Inventory of Problems (SIP) at Baseline | 30 days prior to Baseline | Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use |
| Short Inventory of Problems at 1 Month | 1 month | Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use |
| Short Inventory of Problems at 3 Months | 3 months | Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use |
| Short Inventory of Problems at 6 Months | 6 months | Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use |
| Social Support Survey Total Score at Baseline | 30 days prior to Baseline | Min value:19 Max value:95 Higher score indicates higher support |
| Social Support Survey Total Score at 1 Month | 30 days prior to 1-month follow-up | Min value:19 Max value:95 Higher score indicates higher support |
| Social Support Survey Total Score at 3 Months | 60 days prior to 3-month follow-up | Min value:19 Max value:95 Higher score indicates higher support |
| Social Support Survey Total Score at 6 Months | 90 days prior to 6-month follow-up | Min value:19 Max value:95 Higher score indicates higher support |
| Quality of Life Survey (QOLS) at Baseline | 30 days prior to Baseline | Min value:16 Max value:112 Higher score indicates higher quality of life |
| Quality of Life Survey (QOLS) at 1 Month | 1 month | Min value:16 Max value:112 Higher score indicates higher quality of life |
| Quality of Life Survey (QOLS) at 3 Months | 3 months | Min value:16 Max value:112 Higher score indicates higher quality of life |
| Quality of Life Survey (QOLS) at 6 Months | 6 months | Min value:16 Max value:112 Higher score indicates higher quality of life |
| Brief Symptom Inventory (BSI-18) at Baseline | 30 days prior to Baseline | Min value:0 Max value:72 Higher score indicates higher psychological distress |
| Brief Symptom Inventory(BSI-18) at 1 Month | 1 month | Min value:0 Max value:72 Higher score indicates higher psychological distress |
| Brief Symptom Inventory (BSI-18) at 3 Months | 3 months | Min value:0 Max value:72 Higher score indicates higher psychological distress |
| Brief Symptom Inventory (BSI-18) at 6 Months | 6 months | Min value:0 Max value:72 Higher score indicates higher psychological distress |
| SF-12 Health Survey Physical Summary Score at Baseline | 30 days prior to Baseline | Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health |
| SF-12 Health Survey Physical Summary Score at 1 Month | 1 month | Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health |
| SF-12 Health Survey Physical Summary Score at 3 Months | 3 months | Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health |
| SF-12 Health Survey Physical Summary Score at 6 Months | 6 months | Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health |
Countries
United States
Participant flow
Pre-assignment details
Of the 481 patients screened between September 2015 and January 2018, 38% (n=185) were consented and enrolled. However, only 184 participants were randomized because 1 withdrew during baseline assessments.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 93 |
| 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 submit questions on involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion money management with feedback (2 sessions), cooking-home maintenance, and psycho-education about substance use. | 91 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Did not return after Baseline | 3 | 2 |
| Overall Study | Lost to Follow-up | 5 | 12 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control Treatment Condition (CT) | Total | Group Motivational Interviewing (GMI) |
|---|---|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 9.5 | 51.2 years STANDARD_DEVIATION 9.9 | 50.8 years STANDARD_DEVIATION 10.6 |
| Race/Ethnicity, Customized African American | 69 Participants | 118 Participants | 49 Participants |
| Race/Ethnicity, Customized Caucasian | 22 Participants | 64 Participants | 42 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 91 Participants | 184 Participants | 93 Participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 87 Participants | 174 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 93 | 5 / 91 |
| other Total, other adverse events | 0 / 93 | 0 / 91 |
| serious Total, serious adverse events | 0 / 93 | 0 / 91 |
Outcome results
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Alcohol Drink Days at 1 Month | 4.6 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Alcohol Drink Days at 1 Month | 5.5 Days |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Alcohol Drink Days at 3 Months | 6.2 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Alcohol Drink Days at 3 Months | 6.6 Days |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Alcohol Drink Days at 6 Months | 8.3 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Alcohol Drink Days at 6 Months | 8.3 Days |
Primary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Alcohol Drink Days at Baseline | 13.3 days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Alcohol Drink Days at Baseline | 14.8 days |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Binge Drink Days at 1 Month | 3.0 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Binge Drink Days at 1 Month | 3.0 Days |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Binge Drink Days at 3 Months | 5.1 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Binge Drink Days at 3 Months | 4.0 Days |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Binge Drink Days at 6 Months | 6.2 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Binge Drink Days at 6 Months | 5.7 Days |
Primary
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).
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Binge Drink Days at Baseline | 11.0 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Binge Drink Days at Baseline | 12.0 Days |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Days Involved in Productive Work Activities at 1 Month | 3.6 # of days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Days Involved in Productive Work Activities at 1 Month | 3.5 # of days |
Primary
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Days Involved in Productive Work Activities at 3 Months | 7.0 # of days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Days Involved in Productive Work Activities at 3 Months | 7.0 # of days |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Days Involved in Productive Work Activities at 6 Months | 8.0 # of days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Days Involved in Productive Work Activities at 6 Months | 9.8 # of days |
Primary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Days Involved in Productive Work Activities at Baseline | 2.2 # of days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Days Involved in Productive Work Activities at Baseline | 3.0 # of days |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Illicit Drug Use Days at 1 Month | 2.2 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Illicit Drug Use Days at 1 Month | 1.7 Days |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Illicit Drug Use Days at 3 Months | 2.0 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Illicit Drug Use Days at 3 Months | 2.5 Days |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Illicit Drug Use Days at 6 Months | 3.4 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Illicit Drug Use Days at 6 Months | 3.3 Days |
Primary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Illicit Drug Use Days at Baseline | 6.2 Days |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Illicit Drug Use Days at Baseline | 7.7 Days |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Peak SEC at 1 Month | 4.8 Standard Ethanol Content Units |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Peak SEC at 1 Month | 4.5 Standard Ethanol Content Units |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Peak SEC at 3 Months | 9.8 Standard Ethanol Content Units |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Peak SEC at 3 Months | 5.9 Standard Ethanol Content Units |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Peak SEC at 6 Months | 10.3 Standard Ethanol Content Units |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Peak SEC at 6 Months | 7.2 Standard Ethanol Content Units |
Primary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Peak SEC at Baseline | 21.0 Standard Ethanol Content Units |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Peak SEC at Baseline | 19.1 Standard Ethanol Content Units |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Standard Ethanol Content Units (SECs) at 1 Month | 44.9 Standard Ethanol Content Units |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Standard Ethanol Content Units (SECs) at 1 Month | 36.9 Standard Ethanol Content Units |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Standard Ethanol Content Units (SECs) at 3 Months | 50.1 Standard Ethanol Content Units |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Standard Ethanol Content Units (SECs) at 3 Months | 37.7 Standard Ethanol Content Units |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Standard Ethanol Content Units (SECs) at 6 Months | 96.5 Standard Ethanol Content Units |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Standard Ethanol Content Units (SECs) at 6 Months | 66.9 Standard Ethanol Content Units |
Primary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Standard Ethanol Content Units (SECs) Baseline | 179.9 Standard Ethanol Content Unit |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Standard Ethanol Content Units (SECs) Baseline | 190.1 Standard Ethanol Content Unit |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder Treatment Sessions at 1 Month | 20.9 Sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder Treatment Sessions at 1 Month | 22.2 Sessions |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder Treatment Sessions at 3 Months | 8.1 Sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder Treatment Sessions at 3 Months | 6.3 Sessions |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder Treatment Sessions at 6 Months | 3.2 Sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder Treatment Sessions at 6 Months | 1.8 Sessions |
Primary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder Treatment Sessions at Baseline | 3.7 Sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder Treatment Sessions at Baseline | 4.7 Sessions |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Times Involved in Community Participation Activities at 1 Month | 18.4 # of time activity completed |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Times Involved in Community Participation Activities at 1 Month | 25.2 # of time activity completed |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Times Involved in Community Participation Activities at 3 Months | 16.7 # of times activity completed |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Times Involved in Community Participation Activities at 3 Months | 19.4 # of times activity completed |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Times Involved in Community Participation Activities at 6 Months | 16.7 # of times activity completed |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Times Involved in Community Participation Activities at 6 Months | 14.5 # of times activity completed |
Primary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Times Involved in Community Participation Activities at Baseline | 10.4 # of times activity completed |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Times Involved in Community Participation Activities at Baseline | 14 # of times activity completed |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Twelve-Step Sessions Attended at 1 Month | 10.7 Sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Twelve-Step Sessions Attended at 1 Month | 10.8 Sessions |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Twelve-Step Sessions Attended at 3 Months | 9.8 Sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Twelve-Step Sessions Attended at 3 Months | 7.5 Sessions |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Twelve-Step Sessions Attended at 6 Months | 6.7 Sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Twelve-Step Sessions Attended at 6 Months | 3.8 Sessions |
Primary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Twelve-Step Sessions Attended at Baseline | 5.2 Sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Twelve-Step Sessions Attended at Baseline | 3.8 Sessions |
Secondary
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
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Alcohol Use | 0.18 score on a scale | Standard Deviation 0.23 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Alcohol Use | 0.19 score on a scale | Standard Deviation 0.25 |
Secondary
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
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Psychiatric Status | 0.28 score on a scale | Standard Deviation 0.26 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Psychiatric Status | 0.26 score on a scale | Standard Deviation 0.24 |
Secondary
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 3 Month for Psychiatric Status | 0.30 score on a scale | Standard Deviation 0.28 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 3 Month for Psychiatric Status | 0.26 score on a scale | Standard Deviation 0.25 |
Secondary
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 3 Months for Alcohol Use | 0.31 score on a scale | Standard Deviation 0.35 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 3 Months for Alcohol Use | 0.27 score on a scale | Standard Deviation 0.4 |
Secondary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Alcohol Use | 0.49 score on a scale | Standard Deviation 0.57 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Alcohol Use | 0.41 score on a scale | Standard Deviation 0.56 |
Secondary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Psychiatric Status | 0.38 score on a scale | Standard Deviation 0.28 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Psychiatric Status | 0.30 score on a scale | Standard Deviation 0.26 |
Secondary
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
Time frame: 30 days prior to Baseline
Population: The ASI-Lite measures addiction severity
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use | 0.50 score on a scale | Standard Deviation 0.22 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use | 0.50 score on a scale | Standard Deviation 0.22 |
Secondary
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
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status | 0.47 score on a scale | Standard Deviation 0.21 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status | 0.40 score on a scale | Standard Deviation 0.23 |
Secondary
Brief Symptom Inventory(BSI-18) at 1 Month
Min value:0 Max value:72 Higher score indicates higher psychological distress
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Brief Symptom Inventory(BSI-18) at 1 Month | 15.9 score on a scale | Standard Deviation 12.4 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Brief Symptom Inventory(BSI-18) at 1 Month | 14.2 score on a scale | Standard Deviation 12.6 |
Secondary
Brief Symptom Inventory (BSI-18) at 3 Months
Min value:0 Max value:72 Higher score indicates higher psychological distress
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Brief Symptom Inventory (BSI-18) at 3 Months | 16.1 score on a scale | Standard Deviation 13.8 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Brief Symptom Inventory (BSI-18) at 3 Months | 13.1 score on a scale | Standard Deviation 11.5 |
Secondary
Brief Symptom Inventory (BSI-18) at 6 Months
Min value:0 Max value:72 Higher score indicates higher psychological distress
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Brief Symptom Inventory (BSI-18) at 6 Months | 17.2 score on a scale | Standard Deviation 14.6 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Brief Symptom Inventory (BSI-18) at 6 Months | 15.9 score on a scale | Standard Deviation 13.6 |
Secondary
Brief Symptom Inventory (BSI-18) at Baseline
Min value:0 Max value:72 Higher score indicates higher psychological distress
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Brief Symptom Inventory (BSI-18) at Baseline | 21.4 score on a scale | Standard Deviation 14 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Brief Symptom Inventory (BSI-18) at Baseline | 19.3 score on a scale | Standard Deviation 14.6 |
Secondary
Fagerstrom Test for Nicotine Dependence at Baseline
Min:0 Max:10 Higher score indicates higher level of nicotine dependence
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Fagerstrom Test for Nicotine Dependence at Baseline | 4.5 score on a scale | Standard Deviation 2.4 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Fagerstrom Test for Nicotine Dependence at Baseline | 4.0 score on a scale | Standard Deviation 2.2 |
Secondary
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
Time frame: Completed during session 4 of treatment group (i.e. the final treatment session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Helping Alliance Questionnaire - Total Score | 100.1 score on a scale | Standard Deviation 10.9 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Helping Alliance Questionnaire - Total Score | 101.6 score on a scale | Standard Deviation 9.4 |
Secondary
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.
Time frame: 1 Month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Mental Health Treatment Sessions at 1 Month | 0.79 sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Mental Health Treatment Sessions at 1 Month | 0.39 sessions |
Secondary
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.
Time frame: 3 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Mental Health Treatment Sessions at 3 Months | 1.0 sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Mental Health Treatment Sessions at 3 Months | 0.25 sessions |
Secondary
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Mental Health Treatment Sessions at 6 Months | 0.78 sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Mental Health Treatment Sessions at 6 Months | 0.27 sessions |
Secondary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Mental Health Treatment Sessions at Baseline | 0.36 sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Mental Health Treatment Sessions at Baseline | 0.20 sessions |
Secondary
Psychiatric Outpatient Satisfaction Scale - Total Score
Min:13 Max:65 Higher score indicates better satisfaction
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Psychiatric Outpatient Satisfaction Scale - Total Score | 61.1 score on a scale | Standard Deviation 9.4 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Psychiatric Outpatient Satisfaction Scale - Total Score | 60.1 score on a scale | Standard Deviation 9.8 |
Secondary
Quality of Life Survey (QOLS) at 1 Month
Min value:16 Max value:112 Higher score indicates higher quality of life
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Quality of Life Survey (QOLS) at 1 Month | 71.2 score on a scale | Standard Deviation 15.3 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Quality of Life Survey (QOLS) at 1 Month | 73.5 score on a scale | Standard Deviation 15.8 |
Secondary
Quality of Life Survey (QOLS) at 3 Months
Min value:16 Max value:112 Higher score indicates higher quality of life
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Quality of Life Survey (QOLS) at 3 Months | 72.4 score on a scale | Standard Deviation 16.5 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Quality of Life Survey (QOLS) at 3 Months | 75.1 score on a scale | Standard Deviation 17.9 |
Secondary
Quality of Life Survey (QOLS) at 6 Months
Min value:16 Max value:112 Higher score indicates higher quality of life
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Quality of Life Survey (QOLS) at 6 Months | 71.3 score on a scale | Standard Deviation 18.3 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Quality of Life Survey (QOLS) at 6 Months | 72.6 score on a scale | Standard Deviation 18.6 |
Secondary
Quality of Life Survey (QOLS) at Baseline
Min value:16 Max value:112 Higher score indicates higher quality of life
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Quality of Life Survey (QOLS) at Baseline | 61.6 score on a scale | Standard Deviation 18.4 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Quality of Life Survey (QOLS) at Baseline | 68.8 score on a scale | Standard Deviation 17.6 |
Secondary
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
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Mental Summary Score at 1 Month | 43.9 score on a scale | Standard Deviation 11.3 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Mental Summary Score at 1 Month | 44.5 score on a scale | Standard Deviation 10.8 |
Secondary
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Mental Summary Score at 3 Months | 43.0 score on a scale | Standard Deviation 11.5 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Mental Summary Score at 3 Months | 44.7 score on a scale | Standard Deviation 10.5 |
Secondary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Mental Summary Score at 6 Months | 42.7 score on a scale | Standard Deviation 11.8 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Mental Summary Score at 6 Months | 44.6 score on a scale | Standard Deviation 11.1 |
Secondary
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
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Mental Summary Score at Baseline | 35.9 score on a scale | Standard Deviation 11.4 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Mental Summary Score at Baseline | 39.0 score on a scale | Standard Deviation 11.9 |
Secondary
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
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Physical Summary Score at 1 Month | 40.2 score on a scale | Standard Deviation 11.4 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Physical Summary Score at 1 Month | 43.6 score on a scale | Standard Deviation 11.7 |
Secondary
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Physical Summary Score at 3 Months | 41.0 score on a scale | Standard Deviation 10.5 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Physical Summary Score at 3 Months | 42.2 score on a scale | Standard Deviation 11.4 |
Secondary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Physical Summary Score at 6 Months | 40.4 score on a scale | Standard Deviation 11.1 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Physical Summary Score at 6 Months | 40.8 score on a scale | Standard Deviation 11.9 |
Secondary
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
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Physical Summary Score at Baseline | 41.6 score on a scale | Standard Deviation 11.8 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | SF-12 Health Survey Physical Summary Score at Baseline | 41.6 score on a scale | Standard Deviation 11.3 |
Secondary
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
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Short Inventory of Problems at 1 Month | 6.5 score on a scale | Standard Deviation 10.6 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Short Inventory of Problems at 1 Month | 6.9 score on a scale | Standard Deviation 10.9 |
Secondary
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Short Inventory of Problems at 3 Months | 9.8 score on a scale | Standard Deviation 12.2 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Short Inventory of Problems at 3 Months | 7.6 score on a scale | Standard Deviation 10.7 |
Secondary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Short Inventory of Problems at 6 Months | 11.1 score on a scale | Standard Deviation 12.4 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Short Inventory of Problems at 6 Months | 10.8 score on a scale | Standard Deviation 12.5 |
Secondary
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
Time frame: 30 days prior to Baseline
Population: Short Inventory of Problems - Total Score at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Short Inventory of Problems (SIP) at Baseline | 27.0 score on a scale | Standard Deviation 12.6 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Short Inventory of Problems (SIP) at Baseline | 26.1 score on a scale | Standard Deviation 12.2 |
Secondary
Social Support Survey Total Score at 1 Month
Min value:19 Max value:95 Higher score indicates higher support
Time frame: 30 days prior to 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Social Support Survey Total Score at 1 Month | 63.3 score on a scale | Standard Deviation 21 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Social Support Survey Total Score at 1 Month | 68.2 score on a scale | Standard Deviation 20 |
Secondary
Social Support Survey Total Score at 3 Months
Min value:19 Max value:95 Higher score indicates higher support
Time frame: 60 days prior to 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Social Support Survey Total Score at 3 Months | 63.1 score on a scale | Standard Deviation 21.4 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Social Support Survey Total Score at 3 Months | 66.8 score on a scale | Standard Deviation 19 |
Secondary
Social Support Survey Total Score at 6 Months
Min value:19 Max value:95 Higher score indicates higher support
Time frame: 90 days prior to 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Social Support Survey Total Score at 6 Months | 61.2 score on a scale | Standard Deviation 22 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Social Support Survey Total Score at 6 Months | 65.7 score on a scale | Standard Deviation 19.2 |
Secondary
Social Support Survey Total Score at Baseline
Min value:19 Max value:95 Higher score indicates higher support
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Social Support Survey Total Score at Baseline | 61.1 score on a scale | Standard Deviation 18.6 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Social Support Survey Total Score at Baseline | 60.3 score on a scale | Standard Deviation 21.2 |
Secondary
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.
Time frame: 1 Month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder and Mental Health Treatment Sessions at 1 Month | 21.7 sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder and Mental Health Treatment Sessions at 1 Month | 22.6 sessions |
Secondary
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.
Time frame: 3 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder and Mental Health Treatment Sessions at 3 Months | 9.1 sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder and Mental Health Treatment Sessions at 3 Months | 6.5 sessions |
Secondary
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder and Mental Health Treatment Sessions at 6 Months | 4.0 sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder and Mental Health Treatment Sessions at 6 Months | 2.0 sessions |
Secondary
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.
Time frame: 30 days prior to Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder and Mental Health Treatment Sessions at Baseline | 4.0 sessions |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Substance Use Disorder and Mental Health Treatment Sessions at Baseline | 4.9 sessions |
Secondary
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)
Time frame: 30 days prior to 1-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 1-month | External Reasons | 2.2 score on a scale | Standard Deviation 1.2 |
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 1-month | Internal Reasons | 5.8 score on a scale | Standard Deviation 1.1 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 1-month | External Reasons | 2.6 score on a scale | Standard Deviation 1.5 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 1-month | Internal Reasons | 5.8 score on a scale | Standard Deviation 1.2 |
Secondary
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)
Time frame: 60 days prior to 3-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 3-month | External Reasons | 2 score on a scale | Standard Deviation 1.2 |
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 3-month | Internal Reasons | 5.4 score on a scale | Standard Deviation 1.3 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 3-month | External Reasons | 2.5 score on a scale | Standard Deviation 1.5 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 3-month | Internal Reasons | 5.6 score on a scale | Standard Deviation 1.3 |
Secondary
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)
Time frame: 90 days prior to 6-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 6-months | External Reasons | 2.2 score on a scale | Standard Deviation 1.2 |
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 6-months | Internal Reasons | 5.5 score on a scale | Standard Deviation 1.2 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 6-months | External Reasons | 2.5 score on a scale | Standard Deviation 1.2 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at 6-months | Internal Reasons | 5.3 score on a scale | Standard Deviation 1.2 |
Secondary
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)
Time frame: 30 days prior to Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at Baseline | External Reasons | 2.4 score on a scale | Standard Deviation 1.2 |
| GMI - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at Baseline | Internal Reasons | 6.1 score on a scale | Standard Deviation 1 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at Baseline | External Reasons | 2.6 score on a scale | Standard Deviation 1.4 |
| LSEG - Standard Ethanol Content Units (SECs) at Baseline | Treatment Motivation Questionnaire (TMQ) at Baseline | Internal Reasons | 6.0 score on a scale | Standard Deviation 0.9 |