Pilot Clinical Trial of Computer-based Motivational Intervention - 1

June 10, 2013 updated by: Steven J. Ondersma, Wayne State University

Pilot Clinical Trial of Computer-based Motivational Intervention

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48207
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

September 30, 2005

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-14621-1
  • R21DA014621 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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