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

December 7, 2015 updated by: Virginia Commonwealth University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

713

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 - 65 years
  • Primary care clinic patient

Exclusion Criteria:

  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 health screening
Behavioral intervention
Behavioral: Computerized assessment
Behavioral intervention
Behavioral: Computerized brief intervention
Intervention based on Motivational Interviewing technique
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Substance use
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (ESTIMATE)

October 29, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBIRTVCU
  • R01DA026091 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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