Clinical trial NCT02233738: Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
Official title: Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Substance-related Disorders
Dual Diagnosis
Keywords: Alcoholism
Substance-related disorders
Dual Diagnosis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-09-08
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Standard Ethanol Content Units (SECs) Baseline
timeFrame: 30 days prior to Baseline
measure: Standard Ethanol Content Units (SECs) at 1 Month
timeFrame: 1 month
measure: Standard Ethanol Content Units (SECs) at 3 Months
timeFrame: 3 months
measure: Standard Ethanol Content Units (SECs) at 6 Months
timeFrame: 6 months
measure: Peak SEC at Baseline
timeFrame: 30 days prior to Baseline
measure: Peak SEC at 1 Month
timeFrame: 1 month
measure: Peak SEC at 3 Months
timeFrame: 3 months
measure: Peak SEC at 6 Months
timeFrame: 6 months
measure: Alcohol Drink Days at Baseline
timeFrame: 30 days prior to Baseline
measure: Alcohol Drink Days at 1 Month
timeFrame: 1 month
measure: Alcohol Drink Days at 3 Months
timeFrame: 3 months
measure: Alcohol Drink Days at 6 Months
timeFrame: 6 months
measure: Binge Drink Days at Baseline
timeFrame: 30 days prior to Baseline
measure: Binge Drink Days at 1 Month
timeFrame: 1 month
measure: Binge Drink Days at 3 Months
timeFrame: 3 months
measure: Binge Drink Days at 6 Months
timeFrame: 6 months
measure: Illicit Drug Use Days at Baseline
timeFrame: 30 days prior to Baseline
measure: Illicit Drug Use Days at 1 Month
timeFrame: 1 month
measure: Illicit Drug Use Days at 3 Months
timeFrame: 3 months
measure: Illicit Drug Use Days at 6 Months
timeFrame: 6 months
measure: Substance Use Disorder Treatment Sessions at Baseline
timeFrame: 30 days prior to Baseline
measure: Substance Use Disorder Treatment Sessions at 1 Month
timeFrame: 1 month
measure: Substance Use Disorder Treatment Sessions at 3 Months
timeFrame: 3 months
measure: Substance Use Disorder Treatment Sessions at 6 Months
timeFrame: 6 months
measure: Twelve-Step Sessions Attended at Baseline
timeFrame: 30 days prior to Baseline
measure: Twelve-Step Sessions Attended at 1 Month
timeFrame: 1 month
measure: Twelve-Step Sessions Attended at 3 Months
timeFrame: 3 months
measure: Twelve-Step Sessions Attended at 6 Months
timeFrame: 6 months
measure: Times Involved in Community Participation Activities at Baseline
timeFrame: 30 days prior to Baseline
measure: Times Involved in Community Participation Activities at 1 Month
timeFrame: 1 month
measure: Times Involved in Community Participation Activities at 3 Months
timeFrame: 3 months
measure: Times Involved in Community Participation Activities at 6 Months
timeFrame: 6 months
measure: Days Involved in Productive Work Activities at Baseline
timeFrame: 30 days prior to Baseline
measure: Days Involved in Productive Work Activities at 1 Month
timeFrame: 1 month
measure: Days Involved in Productive Work Activities at 3 Months
timeFrame: 3 months
measure: Days Involved in Productive Work Activities at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Mental Health Treatment Sessions at Baseline
timeFrame: 30 days prior to Baseline
measure: Mental Health Treatment Sessions at 1 Month
timeFrame: 1 Month
measure: Mental Health Treatment Sessions at 3 Months
timeFrame: 3 Months
measure: Mental Health Treatment Sessions at 6 Months
timeFrame: 6 Months
measure: Substance Use Disorder and Mental Health Treatment Sessions at Baseline
timeFrame: 30 days prior to Baseline
measure: Substance Use Disorder and Mental Health Treatment Sessions at 1 Month
timeFrame: 1 Month
measure: Substance Use Disorder and Mental Health Treatment Sessions at 3 Months
timeFrame: 3 Months
measure: Substance Use Disorder and Mental Health Treatment Sessions at 6 Months
timeFrame: 6 Months
measure: Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use
timeFrame: 30 days prior to Baseline
measure: Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Alcohol Use
timeFrame: 1 month
measure: Addiction Severity Index-Lite (ASI-Lite) at 3 Months for Alcohol Use
timeFrame: 3 months
measure: Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Alcohol Use
timeFrame: 6 months
measure: Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status
timeFrame: 30 days prior to Baseline
measure: Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Psychiatric Status
timeFrame: 30 days
measure: Addiction Severity Index-Lite (ASI-Lite) at 3 Month for Psychiatric Status
timeFrame: 3 months
measure: Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Psychiatric Status
timeFrame: 6 months
measure: Short Inventory of Problems (SIP) at Baseline
timeFrame: 30 days prior to Baseline
measure: Short Inventory of Problems at 1 Month
timeFrame: 1 month
measure: Short Inventory of Problems at 3 Months
timeFrame: 3 months
measure: Short Inventory of Problems at 6 Months
timeFrame: 6 months
measure: Social Support Survey Total Score at Baseline
timeFrame: 30 days prior to Baseline
measure: Social Support Survey Total Score at 1 Month
timeFrame: 30 days prior to 1-month follow-up
measure: Social Support Survey Total Score at 3 Months
timeFrame: 60 days prior to 3-month follow-up
measure: Social Support Survey Total Score at 6 Months
timeFrame: 90 days prior to 6-month follow-up
measure: Quality of Life Survey (QOLS) at Baseline
timeFrame: 30 days prior to Baseline
measure: Quality of Life Survey (QOLS) at 1 Month
timeFrame: 1 month
measure: Quality of Life Survey (QOLS) at 3 Months
timeFrame: 3 months
measure: Quality of Life Survey (QOLS) at 6 Months
timeFrame: 6 months
measure: Brief Symptom Inventory (BSI-18) at Baseline
timeFrame: 30 days prior to Baseline
measure: Brief Symptom Inventory(BSI-18) at 1 Month
timeFrame: 1 month
measure: Brief Symptom Inventory (BSI-18) at 3 Months
timeFrame: 3 months
measure: Brief Symptom Inventory (BSI-18) at 6 Months
timeFrame: 6 months
measure: SF-12 Health Survey Physical Summary Score at Baseline
timeFrame: 30 days prior to Baseline
measure: SF-12 Health Survey Physical Summary Score at 1 Month
timeFrame: 1 month
measure: SF-12 Health Survey Physical Summary Score at 3 Months
timeFrame: 3 months
measure: SF-12 Health Survey Physical Summary Score at 6 Months
timeFrame: 6 months
measure: SF-12 Health Survey Mental Summary Score at Baseline
timeFrame: 30 days prior to Baseline
measure: SF-12 Health Survey Mental Summary Score at 1 Month
timeFrame: 1 month
measure: SF-12 Health Survey Mental Summary Score at 3 Months
timeFrame: 3 months
measure: SF-12 Health Survey Mental Summary Score at 6 Months
timeFrame: 6 months
measure: Treatment Motivation Questionnaire (TMQ) at Baseline
timeFrame: 30 days prior to Baseline
measure: Treatment Motivation Questionnaire (TMQ) at 1-month
timeFrame: 30 days prior to 1-month follow-up
measure: Treatment Motivation Questionnaire (TMQ) at 3-month
timeFrame: 60 days prior to 3-month follow-up
measure: Treatment Motivation Questionnaire (TMQ) at 6-months
timeFrame: 90 days prior to 6-month follow-up
measure: Fagerstrom Test for Nicotine Dependence at Baseline
timeFrame: 30 days prior to Baseline
measure: Psychiatric Outpatient Satisfaction Scale - Total Score
timeFrame: 1 month
measure: Helping Alliance Questionnaire - Total Score
timeFrame: Completed during session 4 of treatment group (i.e. the final treatment session)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Elizabeth J. Santa Ana, PhD MA BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaconis M, Santa Ana EJ, Killeen TK, Badour CL, Back SE. Concurrent treatment of PTSD and alcohol use disorder via telehealth in a female Iraq veteran. Am J Addict. 2017 Mar;26(2):112-114. doi: 10.1111/ajad.12481. Epub 2017 Jan 24.
citation: Gebregziabher M, Voronca D, Teklehaimanot A, Santa Ana EJ. Weibull mixture regression for marginal inference in zero-heavy continuous outcomes. Stat Methods Med Res. 2017 Jun;26(3):1476-1499. doi: 10.1177/0962280215583402. Epub 2015 Apr 22.
citation: Shorey RC, Martino S, Lamb KE, LaRowe SD, Santa Ana EJ. Change talk and relatedness in group motivational interviewing: a pilot study. J Subst Abuse Treat. 2015 Apr;51:75-81. doi: 10.1016/j.jsat.2014.11.003. Epub 2014 Nov 20.
citation: Santa Ana EJ, LaRowe SD, Armeson K, Lamb KE, Hartwell K. Impact of group motivational interviewing on enhancing treatment engagement for homeless Veterans with nicotine dependence and other substance use disorders: A pilot investigation. Am J Addict. 2016 Oct;25(7):533-41. doi: 10.1111/ajad.12426. Epub 2016 Sep 2.