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

NCT ID: NCT01003834

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

713 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Screening only

Group Type PLACEBO_COMPARATOR

Computerized health screening

Intervention Type BEHAVIORAL

Behavioral intervention

Assessment

Screening plus assessment

Group Type ACTIVE_COMPARATOR

Computerized health screening

Intervention Type BEHAVIORAL

Behavioral intervention

Computerized assessment

Intervention Type BEHAVIORAL

Behavioral intervention

Computer Intervention

Screening, assessment, and computer-delivered intervention

Group Type EXPERIMENTAL

Computerized brief intervention

Intervention Type BEHAVIORAL

Intervention based on Motivational Interviewing technique

Computerized health screening

Intervention Type BEHAVIORAL

Behavioral intervention

Computerized assessment

Intervention Type BEHAVIORAL

Behavioral intervention

Therapist Intervention

Screening, Assessment, and therapist-delivered intervention

Group Type ACTIVE_COMPARATOR

Computerized health screening

Intervention Type BEHAVIORAL

Behavioral intervention

Computerized assessment

Intervention Type BEHAVIORAL

Behavioral intervention

Therapist-delivered motivational intervention

Intervention Type BEHAVIORAL

Behavioral intervention

Interventions

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Computerized brief intervention

Intervention based on Motivational Interviewing technique

Intervention Type BEHAVIORAL

Computerized health screening

Behavioral intervention

Intervention Type BEHAVIORAL

Computerized assessment

Behavioral intervention

Intervention Type BEHAVIORAL

Therapist-delivered motivational intervention

Behavioral intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 - 65 years
* Primary care clinic patient

Exclusion Criteria

* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dace Svikis, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA026091

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SBIRTVCU

Identifier Type: -

Identifier Source: org_study_id