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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014