NCT02233738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 30, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 16, 2019

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

August 21, 2014

Results QC Date

October 17, 2019

Last Update Submit

July 19, 2023

Conditions

AlcoholismSubstance-related DisordersDual Diagnosis

Keywords

AlcoholismSubstance-related disordersDual Diagnosis

Outcome Measures

Primary Outcomes (36)

  • 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.

    30 days prior to Baseline

  • Standard Ethanol Content Units (SECs) at 1 Month

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

    1 month

  • Standard Ethanol Content Units (SECs) at 3 Months

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

    3 months

  • Standard Ethanol Content Units (SECs) at 6 Months

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

    6 months

  • Peak SEC at Baseline

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

    30 days prior to Baseline

  • Peak SEC at 1 Month

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

    1 month

  • Peak SEC at 3 Months

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

    3 months

  • Peak SEC at 6 Months

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

    6 months

  • Alcohol Drink Days at Baseline

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

    30 days prior to Baseline

  • Alcohol Drink Days at 1 Month

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

    1 month

  • Alcohol Drink Days at 3 Months

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

    3 months

  • Alcohol Drink Days at 6 Months

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

    6 months

  • Binge Drink Days at Baseline

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

    30 days prior to Baseline

  • Binge Drink Days at 1 Month

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

    1 month

  • Binge Drink Days at 3 Months

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

    3 months

  • Binge Drink Days at 6 Months

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

    6 months

  • Illicit Drug Use Days at Baseline

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

    30 days prior to Baseline

  • Illicit Drug Use Days at 1 Month

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

    1 month

  • Illicit Drug Use Days at 3 Months

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

    3 months

  • Illicit Drug Use Days at 6 Months

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

    6 months

  • Substance Use Disorder Treatment Sessions at Baseline

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

    30 days prior to Baseline

  • Substance Use Disorder Treatment Sessions at 1 Month

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

    1 month

  • Substance Use Disorder Treatment Sessions at 3 Months

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

    3 months

  • Substance Use Disorder Treatment Sessions at 6 Months

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

    6 months

  • Twelve-Step Sessions Attended at Baseline

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

    30 days prior to Baseline

  • Twelve-Step Sessions Attended at 1 Month

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

    1 month

  • Twelve-Step Sessions Attended at 3 Months

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

    3 months

  • Twelve-Step Sessions Attended at 6 Months

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

    6 months

  • Times Involved in Community Participation Activities at Baseline

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

    30 days prior to Baseline

  • Times Involved in Community Participation Activities at 1 Month

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

    1 month

  • Times Involved in Community Participation Activities at 3 Months

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

    3 months

  • Times Involved in Community Participation Activities at 6 Months

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

    6 months

  • Days Involved in Productive Work Activities at Baseline

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

    30 days prior to Baseline

  • Days Involved in Productive Work Activities at 1 Month

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

    1 month

  • Days Involved in Productive Work Activities at 3 Months

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

    3 months

  • Days Involved in Productive Work Activities at 6 Months

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

    6 months

Secondary Outcomes (47)

  • Mental Health Treatment Sessions at Baseline

    30 days prior to Baseline

  • Mental Health Treatment Sessions at 1 Month

    1 Month

  • Mental Health Treatment Sessions at 3 Months

    3 Months

  • Mental Health Treatment Sessions at 6 Months

    6 Months

  • Substance Use Disorder and Mental Health Treatment Sessions at Baseline

    30 days prior to Baseline

  • +42 more secondary outcomes

Study Arms (2)

Group Motivational Interviewing (GMI)

EXPERIMENTAL

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

Behavioral: Group Motivational Interviewing (GMI)

Control Treatment Condition (CT)

ACTIVE COMPARATOR

Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to Group Motivational Interviewing (GMI) (i.e., 90 minutes) and will involve the following topics: A popular 'box activity': participants will anonymously write evocative questions on slips of paper involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion (e.g., "How do I talk to my family about my alcohol problem?"), money management with feedback (2 sessions), and cooking-home maintenance.

Behavioral: Control Treatment Condition (CT)

Interventions

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.

Group Motivational Interviewing (GMI)
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.

Control Treatment Condition (CT)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

Related Publications (4)

  • 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.

    PMID: 28118514RESULT

  • 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.

    PMID: 25902801RESULT

  • 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.

    PMID: 25488505RESULT

  • 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.

    PMID: 27589072RESULT

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Elizabeth Santa Ana
Organization
Ralph H. Johnson VA Medical Cneter
Elizabeth.Santaana2@va.gov
843-789-7168

Study Officials

  • Elizabeth J. Santa Ana, PhD MA BA

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2014

First Posted

September 8, 2014

Study Start

September 30, 2015

Primary Completion

July 17, 2018

Study Completion

July 17, 2018

Last Updated

July 27, 2023

Results First Posted

December 16, 2019

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)