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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01003119
Other study ID # SE-2009-0484
Secondary ID R01AA017192
Status Completed
Phase N/A
First received October 26, 2009
Last updated February 3, 2016
Start date February 2009
Est. completion date October 2012

Study information

Verified date February 2016
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Addiction CHESS
Smartphone with ACHESS application loaded onto the phone.

Locations

Country Name City State
United States CAB Health and Recovery Services Boston Massachusetts
United States Fayette Companies Peoria Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View 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. — View 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. Epub 2012 Nov 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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`. 12 months No
Secondary 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. 12 mos. No
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