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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Virginia Commonwealth University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01003834
First received: October 27, 2009
Last updated: December 19, 2013
Last verified: December 2013
  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

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Substance use [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 680
Study Start Date: November 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 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
Criteria

Inclusion Criteria:

  • 18 - 65 years
  • Primary care clinic patient

Exclusion Criteria:

  • Pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003834

Contacts
Contact: Pam Dillon, PharmD 804-827-1519 pmdillon@vcu.edu
Contact: Lynn Hull, PhD 804-828-5596 hulllc@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: Dace Svikis, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Dace Svikis, PhD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01003834     History of Changes
Other Study ID Numbers: SBIRTVCU, R01DA026091
Study First Received: October 27, 2009
Last Updated: December 19, 2013
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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014