Pilot Clinical Trial of Computer-based Motivational Intervention - 1

NCT00230022 | Completed Phase 1 Results

• 2 other identifiers: NIDA-14621-1R21DA014621
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

• Motivation to Change Substance Use

  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

Study Arms (2)

Brief computer-delivered intervention

EXPERIMENTAL

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

Assessment only

NO INTERVENTION

Participants in this arm only completed assessment section, same as intervention group, but then was done.

Interventions

Brief computer-delivered intervention BEHAVIORAL

20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.

Brief computer-delivered intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Self-report of drug use prior to pregnancy

You may not qualify if:

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

Sponsors & Collaborators

• Wayne State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48207, United States

Location

Related Publications (1)

• Ondersma SJ, Chase SK, Svikis DS, Schuster CR. Computer-based brief motivational intervention for perinatal drug use. J Subst Abuse Treat. 2005 Jun;28(4):305-12. doi: 10.1016/j.jsat.2005.02.004.

  PMID: 15925264 RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Small sample size in the pilot clinical trial. Because of this lack of power, a statistically significant difference between groups was not demonstrated, and the 95% Confidence Interval (CI) for the effect size estimate included zero.

Results Point of Contact

• Title: Steven J. Ondersma
• Organization: Wayne State University

s.ondersma@wayne.edu

313-577-6680

Study Officials

• Steven J Ondersma, Ph.D.

  ACT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2005
• First Posted: September 30, 2005
• Study Start: October 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: June 20, 2013
• Results First Posted: June 10, 2013

Record last verified: 2013-06

Locations

US (1)