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Pilot Clinical Trial of Computer-based Motivational Intervention - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00230022
First Posted: September 30, 2005
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
  Purpose
Pilot trial of computer-based motivational intervention. Hypothesis: The brief computer-delivered intervention would result in higher motivation to change at follow-up.

Condition Intervention Phase
Substance-Related Disorders Behavioral: Brief computer-delivered intervention Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Clinical Trial of Computer-based Motivational Intervention

Resource links provided by NLM:


Further study details as provided by Steven J. Ondersma, Wayne State University:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: October 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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
Criteria

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

  Contacts and Locations
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


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

Publications:
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 Submitted: September 29, 2005
First Posted: September 30, 2005
Results First Submitted: October 12, 2011
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


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