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

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMART Recovery face-to-face meetings
Overcoming Addictions web application
Sponsored by
Behavior Therapy Associates, LLP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring alcohol dependence intervention, Internet delivered intervention, alcohol dependence treatment, Internet delivered treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Behavior Therapy Associates, LLP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Face-to-face SMART Recovery meetings

Overcoming Addictions web app

Web app + meetings

Arm Description

Participants in this arm will be asked to attend face-to-face SMART Recovery meetings.

Participants in this condition will use the Overcoming Addictions web application and not attend face-to-face SMART Recovery meetings.

Participants in this condition will be asked to use both the Overcoming Addictions web application and attend face-to-face SMART Recovery meetings.

Outcomes

Primary Outcome Measures

Quantity/frequency of alcohol use: Form 90
Quantity/frequency of alcohol use over the course of 90 days prior to the baseline assessment.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 5, 2011
Last Updated
February 24, 2014
Sponsor
Behavior Therapy Associates, LLP
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01389297
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Behavior Therapy Associates, LLP
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcohol dependence intervention, Internet delivered intervention, alcohol dependence treatment, Internet delivered treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Face-to-face SMART Recovery meetings
Arm Type
Active Comparator
Arm Description
Participants in this arm will be asked to attend face-to-face SMART Recovery meetings.
Arm Title
Overcoming Addictions web app
Arm Type
Experimental
Arm Description
Participants in this condition will use the Overcoming Addictions web application and not attend face-to-face SMART Recovery meetings.
Arm Title
Web app + meetings
Arm Type
Experimental
Arm Description
Participants in this condition will be asked to use both the Overcoming Addictions web application and attend face-to-face SMART Recovery meetings.
Intervention Type
Behavioral
Intervention Name(s)
SMART Recovery face-to-face meetings
Intervention Description
Attending these meetings at least weekly in frequency
Intervention Type
Behavioral
Intervention Name(s)
Overcoming Addictions web application
Intervention Description
Logging into and using the web application at least weekly during the course of the study
Primary Outcome Measure Information:
Title
Quantity/frequency of alcohol use: Form 90
Description
Quantity/frequency of alcohol use over the course of 90 days prior to the baseline assessment.
Time Frame
3 months
Title
Quantity/frequency of alcohol use: Form 90
Description
Quantity/frequency of alcohol use over the course of 90 days from 3-6 months from the baseline assessment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
Description
The quantity and frequency of alcohol and drug related problems in the 90 days from the baseline assessment.
Time Frame
3 months
Title
Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
Description
The quantity and frequency of alcohol and drug related problems over the course of 90 days from 3-6 months from the baseline assessment.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reid K Hester, Ph.D.
Organizational Affiliation
Behavior Therapy Associates, LLP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavior Therapy Associates, LLP
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27701064
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.
Results Reference
derived
PubMed Identifier
23846588
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.
Results Reference
derived

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

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