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Pilot Clinical Trial of Computer-based Motivational Intervention - 1

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ClinicalTrials.gov Identifier: NCT00230022
Recruitment Status : Completed
First Posted : September 30, 2005
Results First Posted : June 10, 2013
Last Update Posted : June 20, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University

Brief Summary:
Pilot trial of computer-based motivational intervention. Hypothesis: The brief computer-delivered intervention would result in higher motivation to change at follow-up.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Behavioral: Brief computer-delivered intervention Phase 1

Detailed Description:
Participants were randomized into brief intervention vs. assessment-only conditions, with follow-up to measure overall motivation to change.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Clinical Trial of Computer-based Motivational Intervention
Study Start Date : October 2004
Primary Completion Date : April 2005
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Brief computer-delivered intervention
A 20-minute interaction with software designed to partially replicate the experience of a brief motivational intervention with a therapist or health care professional. Included decisional balance, normed feedback, and optional goal-setting.
Behavioral: Brief computer-delivered intervention
20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.
No Intervention: Assessment only
Participants in this arm only completed assessment section, same as intervention group, but then was done.

Primary Outcome Measures :
  1. Motivation to Change Substance Use [ Time Frame: One month ]
    An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Woman in immediate post-partum period

Inclusion Criteria:

Self-report of drug use prior to pregnancy

Exclusion Criteria:

Frank psychosis or other cognitive impairment; inability to communicate in English; fatigue; recent receipt of narcotic pain medication; grieving over medically compromised infant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230022

United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
Sponsors and Collaborators
Wayne State University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Steven J Ondersma, Ph.D. ACT

Responsible Party: Steven J. Ondersma, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00230022     History of Changes
Other Study ID Numbers: NIDA-14621-1
R21DA014621 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2005    Key Record Dates
Results First Posted: June 10, 2013
Last Update Posted: June 20, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders