NCT01389297

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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

July 5, 2011

Last Update Submit

February 24, 2014

Conditions

Alcoholism

Keywords

alcohol dependence interventionInternet delivered interventionalcohol dependence treatmentInternet delivered treatment

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)

    3 months

  • Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)

    6 months

Study Arms (3)

Face-to-face SMART Recovery meetings

ACTIVE COMPARATOR

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

Behavioral: SMART Recovery face-to-face meetings

Overcoming Addictions web app

EXPERIMENTAL

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

Web app + meetings

EXPERIMENTAL

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 meetingsBehavioral: Overcoming Addictions web application

Interventions

SMART Recovery face-to-face meetingsBEHAVIORAL

Attending these meetings at least weekly in frequency

Face-to-face SMART Recovery meetingsWeb app + meetings
Overcoming Addictions web applicationBEHAVIORAL

Logging into and using the web application at least weekly during the course of the study

Overcoming Addictions web appWeb app + meetings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavior Therapy Associates, LLP

Albuquerque, New Mexico, 87112, United States

Location

Related Publications (2)

  • 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.

    PMID: 27701064DERIVED

  • 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.

    PMID: 23846588DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Reid K Hester, Ph.D.

    Behavior Therapy Associates, LLP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 8, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

US(1)