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Completed

NCT Number: NCT02233738

Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Dual Diagnosis Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Motivational Interviewing (GMI)

Behavioral

Participants randomized to Group Motivational Interviewing (GMI) will receive four structured, back-to-back, 90-minute sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both.

Control Treatment Condition (CT)

Behavioral

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.

Primary outcomes

  1. Standard Ethanol Content Units (SECs) Baseline

    Time frame: 30 days prior to Baseline

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

  2. Standard Ethanol Content Units (SECs) at 1 Month

    Time frame: 1 month

    The 1-month follow-up was conducted 30 days after day 1 of the treatment group. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.

  3. Standard Ethanol Content Units (SECs) at 3 Months

    Time frame: 3 months

    The 3-month follow-up was conducted 60 days after the 1-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.

  4. Standard Ethanol Content Units (SECs) at 6 Months

    Time frame: 6 months

    The 6-month follow-up was conducted 90 days after the 3-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.

  5. 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.

  6. Peak SEC at 1 Month

    Time frame: 1 month

    The 1-month follow-up was conducted 30 days after day 1 of the treatment group. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed on a single day within the stated time period.

  7. Peak SEC at 3 Months

    Time frame: 3 months

    The 3-month follow-up was conducted 60 days after the 1-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed on a single day within the stated time period.

  8. Peak SEC at 6 Months

    Time frame: 6 months

    The 6-month follow-up was conducted 90 days after the 3-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed on a single day within the stated time period.

  9. Alcohol Drink Days at Baseline

    Time frame: 30 days prior to Baseline

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

  10. Alcohol Drink Days at 1 Month

    Time frame: 1 month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after day 1 of the treatment group. This measure represents the number of days any alcohol was consumed within the stated time period.

  11. Alcohol Drink Days at 3 Months

    Time frame: 3 months

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of days any alcohol was consumed within the stated time period.

  12. Alcohol Drink Days at 6 Months

    Time frame: 6 months

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of days any alcohol was consumed within the stated time period.

  13. Binge Drink Days at Baseline

    Time frame: 30 days prior to Baseline

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to Baseline. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females).

  14. Binge Drink Days at 1 Month

    Time frame: 1 month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.

  15. Binge Drink Days at 3 Months

    Time frame: 3 months

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.

  16. Binge Drink Days at 6 Months

    Time frame: 6 months

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.

  17. Illicit Drug Use Days at Baseline

    Time frame: 30 days prior to Baseline

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

  18. Illicit Drug Use Days at 1 Month

    Time frame: 1 month

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. This measure represents the number of illicit drug use days within the stated time period.

  19. Illicit Drug Use Days at 3 Months

    Time frame: 3 months

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of illicit drug use days within the stated time period.

  20. Illicit Drug Use Days at 6 Months

    Time frame: 6 months

    The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of illicit drug use days within the stated time period.

  21. Substance Use Disorder Treatment Sessions at Baseline

    Time frame: 30 days prior to Baseline

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

  22. Substance Use Disorder Treatment Sessions at 1 Month

    Time frame: 1 month

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

  23. Substance Use Disorder Treatment Sessions at 3 Months

    Time frame: 3 months

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 60 days prior to 3-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.

  24. Substance Use Disorder Treatment Sessions at 6 Months

    Time frame: 6 months

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 60 days prior to 6-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.

  25. Twelve-Step Sessions Attended at Baseline

    Time frame: 30 days prior to Baseline

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

  26. Twelve-Step Sessions Attended at 1 Month

    Time frame: 1 month

    A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days prior to 1-month follow-up.

  27. Twelve-Step Sessions Attended at 3 Months

    Time frame: 3 months

    A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 60 days prior to 3-month follow-up.

  28. Twelve-Step Sessions Attended at 6 Months

    Time frame: 6 months

    A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended in the 90 days prior to 6-month follow-up.

  29. Times Involved in Community Participation Activities at Baseline

    Time frame: 30 days prior to Baseline

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

  30. Times Involved in Community Participation Activities at 1 Month

    Time frame: 1 month

    A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 30 days prior to 1-month follow-up.

  31. Times Involved in Community Participation Activities at 3 Months

    Time frame: 3 months

    A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 60 days prior to 3-month follow-up.

  32. Times Involved in Community Participation Activities at 6 Months

    Time frame: 6 months

    A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 90 days prior to 6-month follow-up.

  33. Days Involved in Productive Work Activities at Baseline

    Time frame: 30 days prior to Baseline

    A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 30 days prior to Baseline.

  34. Days Involved in Productive Work Activities at 1 Month

    Time frame: 1 month

    A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 30 days prior to 1-month follow-up.

  35. Days Involved in Productive Work Activities at 3 Months

    Time frame: 3 months

    A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 60 days prior to 3-month follow-up

  36. Days Involved in Productive Work Activities at 6 Months

    Time frame: 6 months

    A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 90 days prior to 6-month follow-up.

Secondary outcomes

  1. Mental Health Treatment Sessions at Baseline

    Time frame: 30 days prior to Baseline

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

  2. Mental Health Treatment Sessions at 1 Month

    Time frame: 1 Month

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 30 days prior to 1-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.

  3. Mental Health Treatment Sessions at 3 Months

    Time frame: 3 Months

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 60 days prior to 3-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.

  4. Mental Health Treatment Sessions at 6 Months

    Time frame: 6 Months

    A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 90 days prior to 6-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.

  5. Substance Use Disorder and Mental Health Treatment Sessions at Baseline

    Time frame: 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.

  6. Substance Use Disorder and Mental Health Treatment Sessions at 1 Month

    Time frame: 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.

  7. Substance Use Disorder and Mental Health Treatment Sessions at 3 Months

    Time frame: 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.

  8. Substance Use Disorder and Mental Health Treatment Sessions at 6 Months

    Time frame: 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.

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

    Time frame: 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

  10. Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Alcohol Use

    Time frame: 1 month

    The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity

  11. Addiction Severity Index-Lite (ASI-Lite) at 3 Months for Alcohol Use

    Time frame: 3 months

    The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity

  12. Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Alcohol Use

    Time frame: 6 months

    The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity

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

    Time frame: 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

  14. Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Psychiatric Status

    Time frame: 30 days

    The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity

  15. Addiction Severity Index-Lite (ASI-Lite) at 3 Month for Psychiatric Status

    Time frame: 3 months

    The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity

  16. Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Psychiatric Status

    Time frame: 6 months

    The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity

  17. Short Inventory of Problems (SIP) at Baseline

    Time frame: 30 days prior to Baseline

    Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use

  18. Short Inventory of Problems at 1 Month

    Time frame: 1 month

    Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use

  19. Short Inventory of Problems at 3 Months

    Time frame: 3 months

    Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use

  20. Short Inventory of Problems at 6 Months

    Time frame: 6 months

    Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use

  21. Social Support Survey Total Score at Baseline

    Time frame: 30 days prior to Baseline

    Min value:19 Max value:95 Higher score indicates higher support

  22. Social Support Survey Total Score at 1 Month

    Time frame: 30 days prior to 1-month follow-up

    Min value:19 Max value:95 Higher score indicates higher support

  23. Social Support Survey Total Score at 3 Months

    Time frame: 60 days prior to 3-month follow-up

    Min value:19 Max value:95 Higher score indicates higher support

  24. Social Support Survey Total Score at 6 Months

    Time frame: 90 days prior to 6-month follow-up

    Min value:19 Max value:95 Higher score indicates higher support

  25. Quality of Life Survey (QOLS) at Baseline

    Time frame: 30 days prior to Baseline

    Min value:16 Max value:112 Higher score indicates higher quality of life

  26. Quality of Life Survey (QOLS) at 1 Month

    Time frame: 1 month

    Min value:16 Max value:112 Higher score indicates higher quality of life

  27. Quality of Life Survey (QOLS) at 3 Months

    Time frame: 3 months

    Min value:16 Max value:112 Higher score indicates higher quality of life

  28. Quality of Life Survey (QOLS) at 6 Months

    Time frame: 6 months

    Min value:16 Max value:112 Higher score indicates higher quality of life

  29. Brief Symptom Inventory (BSI-18) at Baseline

    Time frame: 30 days prior to Baseline

    Min value:0 Max value:72 Higher score indicates higher psychological distress

  30. Brief Symptom Inventory(BSI-18) at 1 Month

    Time frame: 1 month

    Min value:0 Max value:72 Higher score indicates higher psychological distress

  31. Brief Symptom Inventory (BSI-18) at 3 Months

    Time frame: 3 months

    Min value:0 Max value:72 Higher score indicates higher psychological distress

  32. Brief Symptom Inventory (BSI-18) at 6 Months

    Time frame: 6 months

    Min value:0 Max value:72 Higher score indicates higher psychological distress

  33. SF-12 Health Survey Physical Summary Score at Baseline

    Time frame: 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

  34. SF-12 Health Survey Physical Summary Score at 1 Month

    Time frame: 1 month

    Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health

  35. SF-12 Health Survey Physical Summary Score at 3 Months

    Time frame: 3 months

    Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health

  36. SF-12 Health Survey Physical Summary Score at 6 Months

    Time frame: 6 months

    Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health

  37. SF-12 Health Survey Mental Summary Score at Baseline

    Time frame: 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

  38. SF-12 Health Survey Mental Summary Score at 1 Month

    Time frame: 1 month

    Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health

  39. SF-12 Health Survey Mental Summary Score at 3 Months

    Time frame: 3 months

    Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health

  40. SF-12 Health Survey Mental Summary Score at 6 Months

    Time frame: 6 months

    Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health

  41. 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)

  42. 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)

  43. 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)

  44. 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)

  45. 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

  46. Psychiatric Outpatient Satisfaction Scale - Total Score

    Time frame: 1 month

    Min:13 Max:65 Higher score indicates better satisfaction

  47. 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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 8, 2014
Registry last updated
Jul 27, 2023

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View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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