- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00105729
Substance Abuse Self-Help Group Referral: Outcomes and Services Use
Substance Abuse Self-Help Group Referral: Outcome and Services Use
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Palo Alto, California, United States, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Consecutive substance use disorder outpatients at VA PA HCS and is not cognitively impaired.
Exclusion Criteria:
Cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
DRUG USE AND ALCOHOL USE AT 6 MONTHS AND 1 YEAR
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
SUBSTANCE ABUSE AND PSYCHIATRIC SERVICES USE AT 6 MONTHS AND 1 YEAR
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christine Timko, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Publications and helpful links
General Publications
- 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. doi: 10.1016/j.drugalcdep.2005.11.005. Epub 2005 Dec 9.
- 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. doi: 10.1016/j.drugalcdep.2007.04.007. Epub 2007 May 24.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 20-067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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