Pilot Clinical Trial of Computer-based Motivational Intervention - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT00230022
First received: September 29, 2005
Last updated: June 10, 2013
Last verified: June 2013
  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 Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Clinical Trial of Computer-based Motivational Intervention

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Motivation to Change Substance Use [ Time Frame: One month ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230022

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
Sponsors and Collaborators
Wayne State University
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
Study First Received: September 29, 2005
Results First Received: October 12, 2011
Last Updated: June 10, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014