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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00105729
Other study ID # IIR 20-067
Secondary ID
Status Completed
Phase N/A
First received March 16, 2005
Last updated April 6, 2015
Start date January 2003
Est. completion date April 2005

Study information

Verified date September 2006
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Self-help groups (SHGs) have become an important component of the system of care for patients with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to lower relapse rates and less use of additional treatment services.


Description:

Background:

Self-help groups (SHGs) have become an important component of the system of care for patients with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to lower relapse rates and less use of additional treatment services.

Objectives:

The first objective was to implement and validate procedures to help counselors make effective referrals to SHGs for SUD patients. This project randomly assigned SUD outpatients to a standard referral or an intensive referral condition. We are determining the extent to which intensive referral increased patients' SHG attendance and involvement in comparison to standard referral. The second objective is to determine whether patients who received intensive referral to SHGs have better substance use and functioning outcomes over the 1-year follow-up period, and less use of formal treatment services, thereby reducing costs for VA, than those who received standard referral. The long-term goal is to develop and implement guidelines to facilitate SUD patients' participation in SHGs and thereby improve their quality of life and decrease their use of VA's specialized SUD treatment services.

Methods:

This project used a randomized design in which 345 patients entering VA outpatient SUD treatment were randomly assigned to either standard or intensive referral to SHGs. Standard referral consisted of the counselor recommending SHG participation. The keys to intensive referral included the counselor facilitating direct contact between the patient and a member of the SHG, and counselor follow-up on the recommendation for self-help. Patients were followed at 6 months and 1 year to determine whether intensive referral resulted in more self-help attendance and involvement; in better substance use and functioning outcomes (using the Addiction Severity Index); and in less use of VA services and lower treatment costs (using methods of the VA Health Economics Resource Center). To make these determinations, we are conducting analyses at each follow-up, and then will use hierarchical linear modeling to examine the benefits of intensive referral over time.

Status:

Project work is ongoing.


Recruitment information / eligibility

Status Completed
Enrollment 345
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Consecutive substance use disorder outpatients at VA PA HCS and is not cognitively impaired.

Exclusion Criteria:

Cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Intensive referral to 12-step self-help groups


Locations

Country Name City State
United States VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Timko C, Billow R, DeBenedetti A. Determinants of 12-step group affiliation and moderators of the affiliation-abstinence relationship. Drug Alcohol Depend. 2006 Jun 28;83(2):111-21. Epub 2005 Dec 9. — View Citation

Timko C, DeBenedetti A. A randomized controlled trial of intensive referral to 12-step self-help groups: one-year outcomes. Drug Alcohol Depend. 2007 Oct 8;90(2-3):270-9. Epub 2007 May 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary DRUG USE AND ALCOHOL USE AT 6 MONTHS AND 1 YEAR No
Secondary SUBSTANCE ABUSE AND PSYCHIATRIC SERVICES USE AT 6 MONTHS AND 1 YEAR No
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