Trial Outcomes & Findings for Pilot Clinical Trial of Computer-based Motivational Intervention - 1 (NCT NCT00230022)

NCT ID: NCT00230022

Last Updated: 2013-06-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: One month
• Results posted on: 2013-06-20

Participant Flow

Participant milestones

Measure	Brief Computer-delivered Motivational Intervention Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.	Assessment Only Only assessment, same as completed by intervention group. No further interaction with computer.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Clinical Trial of Computer-based Motivational Intervention - 1

Baseline characteristics by cohort

Measure	Brief Computer-delivered Motivational Intervention n=15 Participants Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.	Assessment Only n=15 Participants Only assessment, same as completed by intervention group. No further interaction with computer.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Baseline motivation	82.5 units on a scale STANDARD_DEVIATION 18.9 • n=5 Participants	79.5 units on a scale STANDARD_DEVIATION 21.2 • n=7 Participants	81.0 units on a scale STANDARD_DEVIATION 20.3 • n=5 Participants

PRIMARY outcome

Timeframe: One month

Population: A total of 30 participants were included in this pilot trial, based primarily on convenience and timeframe. The primary goal was effect-size estimation, so power was not a primary concern. Last Observation Carried Forward(LOCF) was utilized for 8 participants lost to follow-up.

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.

Outcome measures

Measure	Brief Computer-delivered Motivational Intervention n=15 Participants A brief assessment, plus a brief (20-minute) motivational intervention delivered solely by computer. The software was synchronously interactive and followed a traditional motivational interviewing approach.	Assessment Only n=15 Participants Only assessment measures with no subsequent intervention.
Motivation to Change Substance Use	88.8 units on a scale Standard Deviation 10	77.4 units on a scale Standard Deviation 20

Adverse Events

Brief Computer-delivered Motivational Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Assessment Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven J. Ondersma

Wayne State University

Phone: 313-577-6680

Email: s.ondersma@wayne.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place