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Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Behavior Therapy Associates, LLP
ClinicalTrials.gov Identifier:
NCT01389297
First received: July 5, 2011
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

The objective of this research project is to develop, evaluate, and disseminate an Internet-based (web) application for SMART Recovery: Overcoming Addictions (OA). OA will be based on the four point cognitive-behavioral program for SMART Recovery (www.smartrecovery.org). The goal of the OA program is to help users learn cognitive and behavioral skills to abstain from drinking, drug use, and problem gambling.

The investigators will evaluate the effectiveness of the OA web application for heavy drinkers in a randomized clinical trial (RCT) with follow-ups at 3- and 6-months.

The study design has three conditions: 1) participation in face-to-face SMART Recovery meetings alone; 2) use of the OA web application as a stand-alone intervention; and 3) combining the OA web application with participation in face-to-face SMART Recovery meetings.

Study Hypotheses:

  1. All three groups will reduce their alcohol consumption, drug use (if any), and alcohol/drug-related problems relative to their baseline levels at the 3- and 6-month post-baseline assessments.
  2. The OA only group (Experimental group 1) will show a greater reductions in drinking, drug use (if any), and alcohol/drug-related problems relative to the face-to-face only (Control) group.
  3. The OA + face-to-face group (Experimental group 2) will have better outcomes on drinking and drug use variables compared to the Control group.

Condition Intervention
Alcoholism
 Behavioral: SMART Recovery face-to-face meetings
Behavioral: Overcoming Addictions web application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism
U.S. FDA Resources

Further study details as provided by Behavior Therapy Associates, LLP:

Primary Outcome Measures:
  • Quantity/frequency of alcohol use: Form 90 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Quantity/frequency of alcohol use over the course of 90 days prior to the baseline assessment.

  • Quantity/frequency of alcohol use: Form 90 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quantity/frequency of alcohol use over the course of 90 days from 3-6 months from the baseline assessment.


Secondary Outcome Measures:
  • Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The quantity and frequency of alcohol and drug related problems in the 90 days from the baseline assessment.

  • Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The quantity and frequency of alcohol and drug related problems over the course of 90 days from 3-6 months from the baseline assessment.


Estimated Enrollment: 195
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Face-to-face SMART Recovery meetings
Participants in this arm will be asked to attend face-to-face SMART Recovery meetings.
 Behavioral: SMART Recovery face-to-face meetings
Attending these meetings at least weekly in frequency
Experimental: Overcoming Addictions web app
Participants in this condition will use the Overcoming Addictions web application and not attend face-to-face SMART Recovery meetings.
 Behavioral: Overcoming Addictions web application
Logging into and using the web application at least weekly during the course of the study
Experimental: Web app + meetings
Participants in this condition will be asked to use both the Overcoming Addictions web application and attend face-to-face SMART Recovery meetings.
 Behavioral: SMART Recovery face-to-face meetings
Attending these meetings at least weekly in frequency
Behavioral: Overcoming Addictions web application
Logging into and using the web application at least weekly during the course of the study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Minimum age 18.
  2. Positive response to quantity/frequency screening questions regarding heavy drinking in the previous 90 days.
  3. An Alcohol Use Disorders Identification Test (AUDIT) score of 8+.
  4. Is a new member of SMART Recovery(i.e., just joining or joined within the last 4 weeks).
  5. Has a computer at home with Internet access.
  6. Has a primary focus on abstaining from drinking.

Exclusion Criteria:

  1. Court mandated 1st time DWI offenders.
  2. Current diagnosis of drug dependence or consider themselves to be drug dependent.
  3. Current evidence of uncontrolled psychosis or bipolar disorder.
  4. Evidence of significant cognitive impairment from brain dysfunction.
  5. English reading level below the 8th grade.
  6. Unwilling or unable to be available for 3 and 6 month post-baseline assessments.
  7. Unwilling or unable to provide one Significant Other (SO) for corroboration of participant's self-report of drinking and drug use (if any).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389297

Locations
United States, New Mexico
Behavior Therapy Associates, LLP
Albuquerque, New Mexico, United States, 87112
Sponsors and Collaborators
Behavior Therapy Associates, LLP
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Reid K Hester, Ph.D. Behavior Therapy Associates, LLP
  More Information

No publications provided

Responsible Party: Behavior Therapy Associates, LLP
ClinicalTrials.gov Identifier: NCT01389297     History of Changes
Other Study ID Numbers: SRWebCourseRCT, 2R44AA016237
Study First Received: July 5, 2011
Last Updated: August 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Behavior Therapy Associates, LLP:
alcohol dependence intervention
Internet delivered intervention
alcohol dependence treatment
Internet delivered treatment

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013