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

This study is currently recruiting participants.
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

October 27, 2009
December 19, 2013
November 2010
December 2013   (final data collection date for primary outcome measure)
Substance use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01003834 on ClinicalTrials.gov Archive Site
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Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care
Computer vs Therapist-Delivered Brief Interventions for Substance Use in Primary Care

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Substance Use Disorder
  • Behavioral: Computerized brief intervention
    Intervention based on Motivational Interviewing technique
  • Behavioral: Computerized health screening
    Behavioral intervention
  • Behavioral: Computerized assessment
    Behavioral intervention
  • Behavioral: Therapist-delivered motivational intervention
    Behavioral intervention
  • Placebo Comparator: Control
    Screening only
    Intervention: Behavioral: Computerized health screening
  • Active Comparator: Assessment
    Screening plus assessment
    Interventions:
    • Behavioral: Computerized health screening
    • Behavioral: Computerized assessment
  • Experimental: Computer Intervention
    Screening, assessment, and computer-delivered intervention
    Interventions:
    • Behavioral: Computerized brief intervention
    • Behavioral: Computerized health screening
    • Behavioral: Computerized assessment
  • Active Comparator: Therapist Intervention
    Screening, Assessment, and therapist-delivered intervention
    Interventions:
    • Behavioral: Computerized health screening
    • Behavioral: Computerized assessment
    • Behavioral: Therapist-delivered motivational intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
680
January 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 - 65 years
  • Primary care clinic patient

Exclusion Criteria:

  • Pregnant
Both
18 Years to 65 Years
Yes
Contact: Pam Dillon, PharmD 804-827-1519 pmdillon@vcu.edu
Contact: Lynn Hull, PhD 804-828-5596 hulllc@vcu.edu
United States
 
NCT01003834
SBIRTVCU, R01DA026091
Yes
Virginia Commonwealth University
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Dace Svikis, PhD Virginia Commonwealth University
Virginia Commonwealth University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP