The Total Health Study

This study is currently recruiting participants.

Verified October 2012 by University of California, San Francisco

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01415206

First received: August 9, 2011

Last updated: October 14, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention
Risk Reduction Behavior	Behavioral: Extended Staging Health Risk Intervention (S-HRI) Behavioral: Usual Care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Extended Care Treatment of Multiple Risk Behaviors in Complex Patients

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Client engagement with behavior change service referrals [ Time Frame: Up to18 months follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Behavioral changes in multiple risks [ Time Frame: up to 18 months follow-up. ] [ Designated as safety issue: No ]
Improvements in health-related quality of life at 3, 6, 12, and 18 months follow-up. [ Time Frame: up to 18 months follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2011
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Extended Staging Health Risk Intervention (S-HRI)	Behavioral: 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.
Usual Care	Behavioral: 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.

Arms

Assigned Interventions

Experimental: Extended Staging Health Risk Intervention (S-HRI)

Behavioral: 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.

Usual Care

Behavioral: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Inclusion criteria are: at least 18 years of age, enrolled in the 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415206

Locations

United States, California
San Francisco VA Medical Center	Recruiting
San Francisco, California, United States
Contact: Anne Michalek 415-940-1379
Principal Investigator: Peter Banys, MD
Principal Investigator: Judith J Prochaska, PhD, MPH

Sponsors and Collaborators

University of California, San Francisco

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Judith J Prochaska, PhD, MPH

University of California, San Francisco

More Information

No publications provided

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01415206 History of Changes
Other Study ID Numbers:	10-01298
Study First Received:	August 9, 2011
Last Updated:	October 14, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Behavioral changes
Multiple risks

ClinicalTrials.gov processed this record on May 16, 2013

To Top