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

Alcohol Dependence Clinical Trial

— GMI-IHMDs  

Official title:

Impact of Group Motivational Interviewing for Dually Diagnosed Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706901
• Other study ID #: CDA-2-016-08S
• Secondary ID: IIR 13-317-2
• Status: Completed
• Phase: N/A
• Start date: May 3, 2010
• Est. completion date: September 30, 2013

Study information

• Verified date: July 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Drug Dependence
• Dual Diagnosis
• Substance-Related Disorders

Intervention

Behavioral:
• Arm 1 GMI
Participants randomized to GMI received four structured, back-to-back, 75-minute sessions in one week consistent with the central principles and spirit of MI (Miller & Rollnick 2013) and based on a manualized protocol (Martino & Santa Ana 2013; Santa Ana & Martino, 2009). Designed for dually diagnosed patients, a focus of the intervention is to examine the relationship between the substance use and the co-existing psychiatric disorder(s) and the importance of proactively treating both conditions.
• Arm 2 IHMD
Participants randomized to IHMD received a 27 day VA Care Coordination Home Telehealth (CCHT) program targeting acute recovery from alcohol and other drug disorders. IHMD consisted of daily assessment combined with dialogues consisting of motivational interviewing, cognitive behavioral therapy, and 12-step (mutual self-help) facilitation.
• Arm 3 TCC
TCC consisted of a 4-session psychoeducational group (75 minutes per session). Material was delivered using a power point presentation on topics

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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