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Computer-Based Alcohol Use Disorder Recovery System

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Addiction CHESS
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Dependence focused on measuring Alcohol addiction, Alcohol treatment, Alcohol recovery, Post residential treatment DSM-IV diagnosis of alcohol dependence

Eligibility Criteria

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

Inclusion Criteria:

  • All subjects must be at least 18 years of age
  • All subjects must be willing to participate in the study
  • All subjects must be willing to identify two people who could provide contact information about their location for the next year
  • If randomized into ACHESS, all subjects must agree to allow monitoring of their ACHESS usage, including internet browsing
  • All subjects must pass a literacy test

Exclusion Criteria:

  • Homelessness
  • Psychiatric or medical condition that precludes participation in the study including: subjects with a history of suicidality, significant developmental/cognitive impairments that limit their ability to understand the material or have vision problems will not be included in this study.

Sites / Locations

  • Fayette Companies
  • CAB Health and Recovery Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A CHESS

Usual Care

Arm Description

Those in the ACHESS arm will also be given a smart-phone with access to the ACHESS system (the intervention) for a full 12 months. The ACHESS intervention includes: 1) the Core CHESS system that has been tested in several diseases, 2) a proactive computer-based relapse prevention system, 3) data transfer from the phone to a computer accessible by the patient's counselor/care manager, and 4) systems for the patient to maintain contact with his/her Care Manager

Those randomized into the Usual Care group will receive usual medical care.

Outcomes

Primary Outcome Measures

ACHESS + standard care will reduce days of risky drinking over the 12-month follow-up period as measured by three interviews. The time-line follow-back techniques will be used'.

Secondary Outcome Measures

ACHESS will reduce proximal outcomes of cravings and negative affect, and produce distal outcomes of increased complete abstinence from alcohol, days of abstinence and reduced negative consequences of substance use.

Full Information

First Posted
October 26, 2009
Last Updated
February 3, 2016
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01003119
Brief Title
Computer-Based Alcohol Use Disorder Recovery System
Official Title
Developing and Testing a Computer-Based Alcohol Use Disorder Recovery System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this grant is to develop and test a proven computer based quality improvement/behavior change e-Health system (CHESS--Comprehensive Health Enhancement Support System) to help prevent relapse in alcohol dependent patients being discharged from residential treatment. The investigators' primary hypothesis is that ACHESS (Addiction CHESS) will improve competence, relatedness and autonomy, which will reduce the days of risky drinking over a 12-month period.
Detailed Description
The system to be tested (ACHESS - Addiction CHESS) will be delivered through a new modality (smart-phone rather than PC) to make access more widespread, focus on new patients (alcohol dependent patients leaving residential care), offer optional audio delivery to improve access for those who have literacy challenges and be enhanced with services tailored to relapse prevention. ACHESS will offer: 1) communication with peer support groups and addiction experts; 2) timely monitoring to assess risk of relapse, 3) reminders and alerts to encourage adherence to therapeutic goals; 4) addiction-related educational material and tools tailored to the needs of the particular patient, 5) access to selected Internet based resources and 6) communication with a care manager. Patients randomly assigned to ACHESS will learn to use it prior to discharge from residential care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol addiction, Alcohol treatment, Alcohol recovery, Post residential treatment DSM-IV diagnosis of alcohol dependence

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A CHESS
Arm Type
Experimental
Arm Description
Those in the ACHESS arm will also be given a smart-phone with access to the ACHESS system (the intervention) for a full 12 months. The ACHESS intervention includes: 1) the Core CHESS system that has been tested in several diseases, 2) a proactive computer-based relapse prevention system, 3) data transfer from the phone to a computer accessible by the patient's counselor/care manager, and 4) systems for the patient to maintain contact with his/her Care Manager
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Those randomized into the Usual Care group will receive usual medical care.
Intervention Type
Behavioral
Intervention Name(s)
Addiction CHESS
Intervention Description
Smartphone with ACHESS application loaded onto the phone.
Primary Outcome Measure Information:
Title
ACHESS + standard care will reduce days of risky drinking over the 12-month follow-up period as measured by three interviews. The time-line follow-back techniques will be used'.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ACHESS will reduce proximal outcomes of cravings and negative affect, and produce distal outcomes of increased complete abstinence from alcohol, days of abstinence and reduced negative consequences of substance use.
Time Frame
12 mos.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects must be at least 18 years of age All subjects must be willing to participate in the study All subjects must be willing to identify two people who could provide contact information about their location for the next year If randomized into ACHESS, all subjects must agree to allow monitoring of their ACHESS usage, including internet browsing All subjects must pass a literacy test Exclusion Criteria: Homelessness Psychiatric or medical condition that precludes participation in the study including: subjects with a history of suicidality, significant developmental/cognitive impairments that limit their ability to understand the material or have vision problems will not be included in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Gustafson, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fayette Companies
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61654
Country
United States
Facility Name
CAB Health and Recovery Services
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21190410
Citation
Gustafson DH, Shaw BR, Isham A, Baker T, Boyle MG, Levy M. Explicating an evidence-based, theoretically informed, mobile technology-based system to improve outcomes for people in recovery for alcohol dependence. Subst Use Misuse. 2011;46(1):96-111. doi: 10.3109/10826084.2011.521413.
Results Reference
background
PubMed Identifier
23316127
Citation
McTavish FM, Chih MY, Shah D, Gustafson DH. How Patients Recovering From Alcoholism Use a Smartphone Intervention. J Dual Diagn. 2012;8(4):294-304. doi: 10.1080/15504263.2012.723312. Epub 2012 Nov 8.
Results Reference
result
PubMed Identifier
24671165
Citation
Gustafson DH, McTavish FM, Chih MY, Atwood AK, Johnson RA, Boyle MG, Levy MS, Driscoll H, Chisholm SM, Dillenburg L, Isham A, Shah D. A smartphone application to support recovery from alcoholism: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):566-72. doi: 10.1001/jamapsychiatry.2013.4642.
Results Reference
result

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Computer-Based Alcohol Use Disorder Recovery System

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