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

NCT00706901 | Completed Results

• 2 other identifiers: CDA-2-016-08SIIR 13-317-2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependence; Dual Diagnosis; Drug Dependence

Keywords

MI; IHMD

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

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

Study Arms (3)

Arm 1 GMI

EXPERIMENTAL

Patients randomized to GMI received four structured 75-minute sessions consistent with the central principles and style of motivational interviewing (Miller \& Rollnick, 2012). The goal of MI is to develop a sense of discrepancy between personal goals and current behavior and enhance change talk among participants, particularly for taking responsibility of one's substance use and being proactive for remaining in treatment.

Behavioral: Arm 1 GMI; Behavioral: Arm 3 TCC

Arm 2 IHMD

EXPERIMENTAL

Participants randomized to In-Home-Messaging Devices (IHMD) received a 27-day Care Coordination Home Telehealth (CCHT) program targeting their acute recovery from alcohol and other substance use disorder. Participants received their IHMD device through the Charleston VAMC CCHT program, including device accessories and a phone number to reach their CCHT provider. They were provided with specific instructions on how to set up their IHMD in their residence after discharge. The research associate followed-up with the patient one day after receiving the device to ensure that the device was successfully set up and to provide assistance as necessary. Participants received standard VA CCHT services.

Behavioral: Arm 2 IHMD; Behavioral: Arm 3 TCC

Arm 3 TCC

ACTIVE COMPARATOR

Participants randomized to the Treatment Control Condition (TCC) received a psycho-educational group (e.g., addiction as a chronic disease, relapse prevention, developing a plan to prevent relapse) that was delivered with the aid of sequential standardized PowerPoint presentations. Group members were encouraged to ask questions and make comments. Therapists were encouraged to conduct the sessions using an instructional quality that minimized the use of GMI strategies. TCC consisted of four sessions, lasting 75 minutes, and was conducted on four consecutive days within the course of one week.

Behavioral: Arm 3 TCC

Interventions

Arm 1 GMI BEHAVIORAL

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 1 GMI

Arm 2 IHMD BEHAVIORAL

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 2 IHMD

Arm 3 TCC BEHAVIORAL

TCC consisted of a 4-session psychoeducational group (75 minutes per session). Material was delivered using a power point presentation on topics

Arm 1 GMI; Arm 2 IHMD; Arm 3 TCC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related 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):739-46. doi: 10.1007/s00213-011-2592-x. Epub 2012 Jan 11.

  PMID: 22234379 RESULT

• 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.

  PMID: 23497788 RESULT

• 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.

  PMID: 23937090 RESULT

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Elizabeth Santa Ana, Ph.D.
• Organization: Charleston VAMC

elizabeth.santaana2@va.gov

(843) 789-7168

Study Officials

• Elizabeth J. Santa Ana, PhD MA BA

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: May 3, 2010
• Primary Completion: June 30, 2013
• Study Completion: September 30, 2013
• Last Updated: August 8, 2018
• Results First Posted: February 4, 2015

Record last verified: 2018-07

Locations

US (1)