Alcohol Dependence Clinical Trial
— GMI-IHMDsOfficial title:
Impact of Group Motivational Interviewing for Dually Diagnosed Veterans
Verified date | July 2018 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | September 30, 2013 |
Est. primary completion date | June 30, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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): — View 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 — View 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):304-14. doi: 10.1037/a0026511. Epub 2011 Dec 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Alcohol Drinking Days 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 and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days | |
Primary | Number of Alcohol Binge Drinking Days 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 and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days | |
Primary | Standard Number of Alcohol Drinks 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 and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days | |
Primary | Treatment Utilization 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 and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days | |
Primary | 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 | 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 and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days | |
Secondary | Number of Illicit Drug Use Days 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 and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days |
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