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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Completed

CT.gov ID

NCT01003834

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

713

Enrollment

Location

Arms

Duration (Months)

22.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorder	Behavioral: Computerized brief intervention Behavioral: Computerized health screening Behavioral: Computerized assessment Behavioral: Therapist-delivered motivational intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

713 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Substance use [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 - 65 years
Primary care clinic patient

Exclusion Criteria:

Pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Dace Svikis, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT01003834

Other Study ID Numbers:

SBIRTVCU
R01DA026091

First Posted:

Oct 29, 2009

Last Update Posted:

Dec 8, 2015

Last Verified:

Dec 1, 2015

Keywords provided by Virginia Commonwealth University

substance use

drug use

drug abuse

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Dec 8, 2015