NCT02233738

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

Completed NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing Group Motivational Interviewing (GMI) in Alcoholism in 185 participants. Completed in 17 July 2018.

Timeline

30 September 2015

Primary endpoint
17 July 2018

17 July 2018

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	185
Start date	30 September 2015
Primary completion	17 July 2018
Estimated completion	17 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Group Motivational Interviewing (GMI)
• Control Treatment Condition (CT)

Conditions studied

• Alcoholism — all drugs for Alcoholism →
• Substance-related Disorders — all drugs for Substance-related Disorders →
• Dual Diagnosis — all drugs for Dual Diagnosis →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 75, any sex, with Alcoholism or Substance-related Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Standard Ethanol Content Units (SECs) Baseline Primary · 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.

Group	Value	95% CI
GMI - Standard Ethanol Content Units (SECs) at Baseline	179.9	57.4 – 240.6
LSEG - Standard Ethanol Content Units (SECs) at Baseline	190.1	68.5 – 244.7

Standard Ethanol Content Units (SECs) at 1 Month Primary · 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.

Group	Value	95% CI
GMI - Standard Ethanol Content Units (SECs) at 1 Month	44.9	0.0 – 28.2
LSEG - Standard Ethanol Content Units (SECs) at 1 Month	36.9	0.0 – 51.2

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

Group	Value	95% CI
GMI - Standard Ethanol Content Units (SECs) at 3 Months	50.1	0.0 – 54.4
LSEG - Standard Ethanol Content Units (SECs) at 3 Months	37.7	0.0 – 44.5

Standard Ethanol Content Units (SECs) at 6 Months Primary · 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.

Group	Value	95% CI
GMI - Standard Ethanol Content Units (SECs) at 6 Months	96.5	0.0 – 89.7
LSEG - Standard Ethanol Content Units (SECs) at 6 Months	66.9	0.0 – 104.4

Peak SEC at Baseline Primary · 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.

Group	Value	95% CI
GMI - Peak SEC at Baseline	21.0	12.0 – 25.6
LSEG - Peak SEC at Baseline	19.1	10.6 – 25.6

Peak SEC at 1 Month Primary · 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.

Group	Value	95% CI
GMI - Peak SEC at 1 Month	4.8	0.0 – 6.4
LSEG - Peak SEC at 1 Month	4.5	0.0 – 7.4

Peak SEC at 3 Months Primary · 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.

Group	Value	95% CI
GMI - Peak SEC at 3 Months	9.8	0.0 – 13.0
LSEG - Peak SEC at 3 Months	5.9	0.0 – 8.4

Peak SEC at 6 Months Primary · 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.

Group	Value	95% CI
GMI - Peak SEC at 6 Months	10.3	0.0 – 15.8
LSEG - Peak SEC at 6 Months	7.2	0.0 – 10.8

Alcohol Drink Days at Baseline Primary · 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.

Group	Value	95% CI
GMI -Alcohol Drink Days at Baseline	13.3	6.0 – 21.0
LSEG - Alcohol Drink Days at Baseline	14.8	8.0 – 21.0

Alcohol Drink Days at 1 Month Primary · 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.

Group	Value	95% CI
GMI - Alcohol Drink Days at 1 Month	4.6	0.0 – 4.0
LSEG - Alcohol Drink Days at 1 Month	5.5	0.0 – 5.0

Alcohol Drink Days at 3 Months Primary · 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.

Group	Value	95% CI
GMI - Alcohol Drink Days at 3 Months	6.2	0.0 – 9.5
LSEG - Alcohol Drink Days at 3 Months	6.6	0.0 – 12.0

Alcohol Drink Days at 6 Months Primary · 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.

Group	Value	95% CI
GMI - Alcohol Drink Days at 6 Months	8.3	0.0 – 13.7
LSEG - Alcohol Drink Days at 6 Months	8.3	0.0 – 16.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.