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

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389297
• Other study ID #: SRWebCourseRCT
• Secondary ID: 2R44AA016237
• Status: Completed
• Phase: N/A
• First received: July 5, 2011
• Last updated: February 24, 2014
• Start date: September 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Behavior Therapy Associates, LLP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Behavioral:
• SMART Recovery face-to-face meetings
Attending these meetings at least weekly in frequency
• Overcoming Addictions web application
Logging into and using the web application at least weekly during the course of the study

Locations

Country	Name	City	State
United States	Behavior Therapy Associates, LLP	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Behavior Therapy Associates, LLP	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity/frequency of alcohol use: Form 90	Quantity/frequency of alcohol use over the course of 90 days prior to the baseline assessment.	3 months	No
Primary	Quantity/frequency of alcohol use: Form 90	Quantity/frequency of alcohol use over the course of 90 days from 3-6 months from the baseline assessment.	6 months	No
Secondary	Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)	The quantity and frequency of alcohol and drug related problems in the 90 days from the baseline assessment.	3 months	No
Secondary	Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)	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	No