Clinical trial NCT01389297: Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery
Official title: Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: alcohol dependence intervention
Internet delivered intervention
alcohol dependence treatment
Internet delivered treatment
Lead sponsor: Behavior Therapy Associates, LLP
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2011-07-08
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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).

Primary outcomes:
measure: Quantity/frequency of alcohol use: Form 90
timeFrame: 3 months
measure: Quantity/frequency of alcohol use: Form 90
timeFrame: 6 months
Secondary outcomes:
measure: Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
timeFrame: 3 months
measure: Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
timeFrame: 6 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Behavior Therapy Associates, LLP
state: New Mexico
Study officials:
affiliation: Behavior Therapy Associates, LLP
name: Reid K Hester, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.