NCT00706901: GMI-IHMDs

Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans

Completed NA Results posted Last updated 8 August 2018

What this trial tests

NA trial testing Arm 1 GMI in Alcohol Dependence in 180 participants. Completed in 30 September 2013.

Timeline

3 May 2010

Primary endpoint
30 June 2013

30 September 2013

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	180
Start date	3 May 2010
Primary completion	30 June 2013
Estimated completion	30 September 2013
Sites	1 location across United States

Drugs / interventions tested

• Arm 1 GMI
• Arm 2 IHMD
• Arm 3 TCC

Conditions studied

• Alcohol Dependence — all drugs for Alcohol Dependence →
• Dual Diagnosis — all drugs for Dual Diagnosis →
• Drug Dependence — all drugs for Drug Dependence →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 70, any sex, with Alcohol Dependence or Dual Diagnosis. 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.

Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days Primary · One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days

Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).

One month follow up

Group	Value	95% CI
Arm 1 GMI	5.1	± 7.6
Arm 2 IHMD	6.5	± 9.5
Arm 3 TCC	6.7	± 10.3

Three month follow up

Group	Value	95% CI
Arm 1 GMI	8.8	± 13.3
Arm 2 IHMD	10.9	± 16.3
Arm 3 TCC	9.9	± 18.8

Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days Primary · One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days

Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).

One month follow up

Group	Value	95% CI
Arm 1 GMI	3.1	± 6.5
Arm 2 (IHMD)	2.7	± 6.5
Arm 3 TCC	6.1	± 10.5

Three month follow up

Group	Value	95% CI
Arm 1 GMI	5.1	± 10.8
Arm 2 (IHMD)	4.0	± 10.5
Arm 3 TCC	7.9	± 17.7

Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days Primary · One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).

One month follow up

Group	Value	95% CI
Arm 1 GMI	45.1	± 98.1
Arm 2 (IHMD)	45.8	± 100.7
Arm 3 TCC	70.0	± 131.1

Three month follow up

Group	Value	95% CI
Arm 1 GMI	66.5	± 156.6
Arm 2 (IHMD)	64.6	± 129.7
Arm 3 TCC	112.3	± 251.9

Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days Primary · One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.

One month follow up

Group	Value	95% CI
Arm 1 GMI	8.7	± 8.7
Arm 2 (IHMD)	7.0	± 9.6
Arm 3 TCC	8.8	± 9.0

Three month follow up

Group	Value	95% CI
Arm 1 GMI	11.3	± 13.2
Arm 2 (IHMD)	6.4	± 9.8
Arm 3 TCC	8.3	± 11.1

Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days Primary · One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous \[AA/NA\]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell \& Sobell, 1992).

One month follow up

Group	Value	95% CI
Arm 1 GMI	8.0	± 12.0
Arm 2 (IHMD)	5.1	± 8.8
Arm 3 TCC	7.1	± 29.6

Three month follow up

Group	Value	95% CI
Arm 1 GMI	16.2	± 22.4
Arm 2 (IHMD)	10.6	± 16.6
Arm 3 TCC	16.2	± 22.4

Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days Secondary · One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).

One month follow up

Group	Value	95% CI
Arm 1 GMI	0.74	± 1.6
Arm 2 (IHMD)	0.62	± 2.3
Arm 3 TCC	0.7	± 1.6

Three month follow up

Group	Value	95% CI
Arm 1 GMI	0.9	± 2.0
Arm 2 (IHMD)	0.51	± 1.6
Arm 3 TCC	0.7	± 2.0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1 GMI

Serious: 2/59 (3%)

Deaths: —

Arm 2 IHMD

Serious: 0/62 (0%)

Deaths: —

Arm 3 TCC

Serious: 0/59 (0%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	Arm 1 GMI	Arm 2 IHMD	Arm 3 TCC
Suicidal Ideation	Psychiatric disorders	—	—	—
Death due to throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Most-reported serious reactions: Suicidal Ideation, Death due to throat cancer.

Data from ClinicalTrials.gov NCT00706901 adverse events section.

Sponsor's own description

Two approaches for providing evidence-based substance abuse treatment (EBT), group motivational interviewing (GMI) and the In-Home-Messaging-Device (IHMD), are interventions that have the characteristic ability for increasing accessibility to evidence-based treatment among patients with substance use problems and are proposed for investigation. GMI is based on motivational interviewing, an intervention that has shown consistent significant effects in promoting treatment retention and reduced substance use among individuals with substance use disorders, and is delivered in a group format. IHMD is a user-friendly computerized Tele-mental Health communication tool that allows interaction through the telephone line between a Veteran and the health care provider in an individual's home or residential placement. The current proposal aims to determine whether GMI and IHMD lead to a significantly greater increase in treatment engagement and reduction in alcohol use compared to a treatment control condition (TCC) among Veterans with a substance use problem and a co-existing psychiatric disorder.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telemedicine and the assessment of clinician time: a scoping review.
   Kidholm K, Jensen LK, Johansson M, Montori VM. · · 2023 · cited 16× · PMID 38099431 · DOI 10.1017/s0266462323002830
2. Randomized controlled trial of group motivational interviewing for veterans with substance use disorders.
   Santa Ana EJ, LaRowe SD, Gebregziabher M, Morgan-Lopez AA, et al · · 2021 · cited 9× · PMID 33873028 · DOI 10.1016/j.drugalcdep.2021.108716