Clinical trial NCT00706901: Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans
Official title: Impact of Group Motivational Interviewing for Dually Diagnosed Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Dual Diagnosis
Drug Dependence
Keywords: MI
IHMD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-06-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Dually diagnosed Veterans (N = 178) will be recruited from the Charleston, SC VAMC Outpatient Substance Abuse Treatment Center (SATC) and block randomized to TAU, GMI, or IHMD. Patients with alcohol dependence or abuse (including drug abuse) and a nonsubstance-related major Axis I disorder (e.g., bipolar disorder, depression, psychotic disorder) will be eligible for the study. Participants, who were referred to the study at time of triage or during the orientation phase of SATC, will be evaluated at baseline and approximately at a 1 and 3-month follow-up. Primary outcome measures will be alcohol use and treatment utilization as measured by number of days of alcohol use, number of binge alcohol drinking days, and quantity of alcohol consumed (in standard drinks, or SECs), and treatment attendance sessions based on objective CPRS patient medical records (i.e., number of all substance abuse outpatient, other mental health \[e.g., PTSD, depression\], and other substance abuse treatment sessions), and self-reported 12-step (number of self-help AA/NA) sessions, including days consulting with a 12-step or mutual self-help sponsor. Exploratory outcomes measures include number of illicit drug use days (e.g., cocaine, crack, marijuana, opiates, and sedatives).

Primary questions:

A. Does GMI lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC?

Hypothesis: Participants who receive GMI will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period.

B. Does IHMD lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC?

Hypothesis: Participants who receive IHMD will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period.

Exploratory question:

Compared to TCC, will GMI and IHMD lead to significantly fewer days of illicit drug use by 3-month follow-up?

Hypothesis: Compared to TCC, GMI and IHMD will result in a significant reduction in days of illicit drug use by 3-month follow-up.

Eligibility criteria: Inclusion Criteria:

* ability to provide informed consent
* reading level at least at the 5th grade level
* ability to identify at least one collateral contact
* ability to be contacted by telephone at follow-up
* access to a working telephone line in the home or residential placement
* alcohol use or alcohol and drug use in the 28 days prior to hospitalization and current alcohol dependence (or abuse) or alcohol and drug abuse

Exclusion Criteria:

* auditory or visual impairment that would interfere with study procedures
* scheduled for discharge within 72 hours of initial screening
* diagnosis of dementia
* inability to speak or understand English
* unable to access a landline telephone for the IHMD treatment group

Primary outcomes:
measure: Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
timeFrame: One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days
measure: Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
timeFrame: One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days
measure: Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
timeFrame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
measure: Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
timeFrame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
measure: 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
timeFrame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Secondary outcomes:
measure: Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
timeFrame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
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: Price KL, Baker NL, McRae-Clark AL, Saladin ME, Desantis SM, Santa Ana EJ, Brady KT. A randomized, placebo-controlled laboratory study of the effects of D-cycloserine on craving in cocaine-dependent individuals. Psychopharmacology (Berl). 2013 Apr;226(4):739-46. doi: 10.1007/s00213-011-2592-x. Epub 2012 Jan 11.
citation: Prisciandaro JJ, Myrick H, Henderson S, McRae-Clark AL, Santa Ana EJ, Saladin ME, Brady KT. Impact of DCS-facilitated cue exposure therapy on brain activation to cocaine cues in cocaine dependence. Drug Alcohol Depend. 2013 Sep 1;132(1-2):195-201. doi: 10.1016/j.drugalcdep.2013.02.009. Epub 2013 Mar 14.
citation: Santa Ana EJ, Stallings DL, Rounsaville BJ, Martino S. Development of an in-home telehealth program for outpatient veterans with substance use disorders. Psychol Serv. 2013 Aug;10(3):304-314. doi: 10.1037/a0026511. Epub 2011 Dec 12.