NCT01003834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
713

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
2 years until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

2.1 years

First QC Date

October 27, 2009

Last Update Submit

December 7, 2015

Conditions

Substance Use Disorder

Keywords

substance usedrug usedrug abuse

Outcome Measures

Primary Outcomes (1)

  • Substance use

    3 months

Study Arms (4)

Control

PLACEBO COMPARATOR

Screening only

Behavioral: Computerized health screening

Assessment

ACTIVE COMPARATOR

Screening plus assessment

Behavioral: Computerized health screeningBehavioral: Computerized assessment

Computer Intervention

EXPERIMENTAL

Screening, assessment, and computer-delivered intervention

Behavioral: Computerized brief interventionBehavioral: Computerized health screeningBehavioral: Computerized assessment

Therapist Intervention

ACTIVE COMPARATOR

Screening, Assessment, and therapist-delivered intervention

Behavioral: Computerized health screeningBehavioral: Computerized assessmentBehavioral: Therapist-delivered motivational intervention

Interventions

Computerized brief interventionBEHAVIORAL

Intervention based on Motivational Interviewing technique

Computer Intervention
Computerized health screeningBEHAVIORAL

Behavioral intervention

AssessmentComputer InterventionControlTherapist Intervention
Computerized assessmentBEHAVIORAL

Behavioral intervention

AssessmentComputer InterventionTherapist Intervention
Therapist-delivered motivational interventionBEHAVIORAL

Behavioral intervention

Therapist Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Primary care clinic patient

You may not qualify if:

  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Dace Svikis, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 29, 2009

Study Start

November 1, 2011

Primary Completion

December 1, 2013

Study Completion

July 1, 2014

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

US(1)