Overview

This trial is active, not recruiting.

Condition risk reduction behavior
Treatments extended staging health risk intervention (s-hri), usual care
Sponsor University of California, San Francisco
Collaborator National Institute on Drug Abuse (NIDA)
Start date August 2011
End date April 2013
Trial size 250 participants
Trial identifier NCT01415206, 10-01298, P50 DA009253

Summary

This study is a randomized, controlled, multiple risk intervention pilot study evaluated with clients recruited from VA Medical Center Substance Abuse Programs. The intervention combines an innovative online system with interpersonal MI-based coaching delivered in 4 sessions over 12-months time.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
The S-HRI provides feedback on participants' stages of change for each risk and the single most important step they can take to begin progressing. A counselor will review the report with participants and provide motivational interviewing (MI) coaching and referrals to relevant behavior change services. Repeated computer and individual counseling contacts at baseline, 3, 6 and 12 months follow-up are designed to support participants through the process of changing multiple risk behaviors.
extended staging health risk intervention (s-hri)
The S-HRI provides feedback on participants' stages of change for each risk and the single most important step they can take to begin progressing. A counselor will review the report with participants and provide motivational interviewing (MI) coaching and referrals to relevant behavior change services. Repeated computer and individual counseling contacts at baseline, 3, 6 and 12 months follow-up are designed to support participants through the process of changing multiple risk behaviors.
(Other)
Participants in the usual care condition will complete the core assessments and the Staging Health Risk Assessment (S-HRA) online at baseline, 3, 6, 12, and 18 months follow-up but will not meet with the study MI coach and will NOT receive any feedback or printed report until the 18-month follow-up.
usual care
Participants in the usual care condition will complete the core assessments and the S-HRA online at baseline, 3, 6, 12,and 18 months follow-up but will not meet with the study MI coach and will NOT receive any feedback or printed report until the 18-month follow-up.

Primary Outcomes

Measure
Client engagement with behavior change service referrals
time frame: Up to18 months follow-up.

Secondary Outcomes

Measure
Behavioral changes in multiple risks
time frame: up to 18 months follow-up.
Improvements in health-related quality of life at 3, 6, 12, and 18 months follow-up.
time frame: up to 18 months follow-up.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Inclusion criteria are: at least 18 years of age, enrolled in the San Francisco Veteran Affairs Medical Center (SF VAMC) Substance Abuse Programs, residing in the San Francisco Bay Area and not planning to relocate out of the area in the next 18 months. For patients in the Day Hospital, we will wait until they have completed one week of treatment before approaching for study involvement, as the first week is the most intensive for services. Exclusion Criteria: - Exclusion criteria are: unstable psychiatric disorder and severe cognitive impairment.

Additional Information

Official title Extended Care Treatment of Multiple Risk Behaviors in Complex Patients
Principal investigator Judith J Prochaska, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.