- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01389297
Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery
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:
- 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.
- 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.
- The OA + face-to-face group (Experimental group 2) will have better outcomes on drinking and drug use variables compared to the Control group.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87112
- Behavior Therapy Associates, LLP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Minimum age 18.
- Positive response to quantity/frequency screening questions regarding heavy drinking in the previous 90 days.
- An Alcohol Use Disorders Identification Test (AUDIT) score of 8+.
- Is a new member of SMART Recovery(i.e., just joining or joined within the last 4 weeks).
- Has a computer at home with Internet access.
- Has a primary focus on abstaining from drinking.
Exclusion Criteria:
- Court mandated 1st time DWI offenders.
- Current diagnosis of drug dependence or consider themselves to be drug dependent.
- Current evidence of uncontrolled psychosis or bipolar disorder.
- Evidence of significant cognitive impairment from brain dysfunction.
- English reading level below the 8th grade.
- Unwilling or unable to be available for 3 and 6 month post-baseline assessments.
- Unwilling or unable to provide one Significant Other (SO) for corroboration of participant's self-report of drinking and drug use (if any).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Face-to-face SMART Recovery meetings
Participants in this arm will be asked to attend face-to-face SMART Recovery 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.
|
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.
|
Attending these meetings at least weekly in frequency
Logging into and using the web application at least weekly during the course of the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantity/frequency of alcohol use: Form 90
Time Frame: 3 months
|
Quantity/frequency of alcohol use over the course of 90 days prior to the baseline assessment.
|
3 months
|
Quantity/frequency of alcohol use: Form 90
Time Frame: 6 months
|
Quantity/frequency of alcohol use over the course of 90 days from 3-6 months from the baseline assessment.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
Time Frame: 3 months
|
The quantity and frequency of alcohol and drug related problems in the 90 days from the baseline assessment.
|
3 months
|
Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
Time Frame: 6 months
|
The quantity and frequency of alcohol and drug related problems over the course of 90 days from 3-6 months from the baseline assessment.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reid K Hester, Ph.D., Behavior Therapy Associates, LLP
Publications and helpful links
General Publications
- Campbell W, Hester RK, Lenberg KL, Delaney HD. Overcoming Addictions, a Web-Based Application, and SMART Recovery, an Online and In-Person Mutual Help Group for Problem Drinkers, Part 2: Six-Month Outcomes of a Randomized Controlled Trial and Qualitative Feedback From Participants. J Med Internet Res. 2016 Oct 4;18(10):e262. doi: 10.2196/jmir.5508.
- Hester RK, Lenberg KL, Campbell W, Delaney HD. Overcoming Addictions, a Web-based application, and SMART Recovery, an online and in-person mutual help group for problem drinkers, part 1: three-month outcomes of a randomized controlled trial. J Med Internet Res. 2013 Jul 11;15(7):e134. doi: 10.2196/jmir.2565.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRWebCourseRCT
- 2R44AA016237 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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