Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care

Substance Use Disorder Clinical Trial

— SBIRT  

Official title:

Computer vs Therapist-Delivered Brief Interventions for Substance Use in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003834
• Other study ID #: SBIRTVCU
• Secondary ID: R01DA026091
• Status: Completed
• Phase: N/A
• First received: October 27, 2009
• Last updated: December 7, 2015
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: December 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 713
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 - 65 years

• Primary care clinic patient

Exclusion Criteria:

• Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Computerized brief intervention
Intervention based on Motivational Interviewing technique
• Computerized health screening
Behavioral intervention
• Computerized assessment
Behavioral intervention
• Therapist-delivered motivational intervention
Behavioral intervention

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use		3 months	No