Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT)
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Purpose
This is a randomized, controlled clinical trial to evaluate the effect of a computerized screening, assessment, and brief intervention on substance use in patients recruited from a primary care clinic. Study participants will be assigned to one of the following 4 study groups: computerized health screening alone (standard care) (SC); computerized assessment-only intervention (CA); computerized assessment followed by a computer-directed motivational intervention (CACI); or computerized assessment followed by a therapist-delivered motivational intervention (CATI). Data regarding substance use, medical and psychosocial functioning, and economic outcomes will be collected.
The investigators hypothesize that patients randomized to CACI and CATI will be more likely to report drug abstinence at the 3-month follow-up visit and will show greater reductions in drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly, patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors, lower rates of medical and psychosocial problems, and increased economic gains at the 6-month follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes superior to those found for SC patients. A cost-effectiveness analysis will also be done comparing economic costs associated with CA, CACI and CATI and their relationship to substance use reductions and related improvements in medical and psychosocial outcomes at the 6 month follow-up.
| Condition | Intervention |
|---|---|
|
Substance Use Disorder |
Behavioral: Computerized brief intervention Behavioral: Computerized health screening Behavioral: Computerized assessment Behavioral: Therapist-delivered motivational intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Computer vs Therapist-Delivered Brief Interventions for Substance Use in Primary Care |
- Substance use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 680 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control
Screening only
|
Behavioral: Computerized health screening
Behavioral intervention
|
|
Active Comparator: Assessment
Screening plus assessment
|
Behavioral: Computerized health screening
Behavioral intervention
Behavioral: Computerized assessment
Behavioral intervention
|
|
Experimental: Computer Intervention
Screening, assessment, and computer-delivered intervention
|
Behavioral: Computerized brief intervention
Intervention based on Motivational Interviewing technique
Behavioral: Computerized health screening
Behavioral intervention
Behavioral: Computerized assessment
Behavioral intervention
|
|
Active Comparator: Therapist Intervention
Screening, Assessment, and therapist-delivered intervention
|
Behavioral: Computerized health screening
Behavioral intervention
Behavioral: Computerized assessment
Behavioral intervention
Behavioral: Therapist-delivered motivational intervention
Behavioral intervention
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 18 - 65 years
- Primary care clinic patient
Exclusion Criteria:
- Pregnant
Contacts and Locations| Contact: Pam Dillon, PharmD | 804-827-1519 | pmdillon@vcu.edu |
| Contact: Lynn Hull, PhD | 804-828-5596 | hulllc@vcu.edu |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Principal Investigator: Dace Svikis, PhD | |
| Principal Investigator: | Dace Svikis, PhD | Virginia Commonwealth University |
More Information
No publications provided
| Responsible Party: | Dace Svikis, PhD, Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01003834 History of Changes |
| Other Study ID Numbers: | SBIRTVCU, R01DA026091 |
| Study First Received: | October 27, 2009 |
| Last Updated: | June 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
|
substance use drug use drug abuse |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013