Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT)
Primary Purpose
Substance Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized brief intervention
Computerized health screening
Computerized assessment
Therapist-delivered motivational intervention
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorder focused on measuring substance use, drug use, drug abuse
Eligibility Criteria
Inclusion Criteria:
- 18 - 65 years
- Primary care clinic patient
Exclusion Criteria:
- Pregnant
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Experimental
Active Comparator
Arm Label
Control
Assessment
Computer Intervention
Therapist Intervention
Arm Description
Screening only
Screening plus assessment
Screening, assessment, and computer-delivered intervention
Screening, Assessment, and therapist-delivered intervention
Outcomes
Primary Outcome Measures
Substance use
Secondary Outcome Measures
Full Information
NCT ID
NCT01003834
First Posted
October 27, 2009
Last Updated
December 7, 2015
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01003834
Brief Title
Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care
Acronym
SBIRT
Official Title
Computer vs Therapist-Delivered Brief Interventions for Substance Use in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder
Keywords
substance use, drug use, drug abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
713 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Screening only
Arm Title
Assessment
Arm Type
Active Comparator
Arm Description
Screening plus assessment
Arm Title
Computer Intervention
Arm Type
Experimental
Arm Description
Screening, assessment, and computer-delivered intervention
Arm Title
Therapist Intervention
Arm Type
Active Comparator
Arm Description
Screening, Assessment, and therapist-delivered intervention
Intervention Type
Behavioral
Intervention Name(s)
Computerized brief intervention
Intervention Description
Intervention based on Motivational Interviewing technique
Intervention Type
Behavioral
Intervention Name(s)
Computerized health screening
Intervention Description
Behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Computerized assessment
Intervention Description
Behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Therapist-delivered motivational intervention
Intervention Description
Behavioral intervention
Primary Outcome Measure Information:
Title
Substance use
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 - 65 years
Primary care clinic patient
Exclusion Criteria:
Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dace Svikis, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care
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