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OpenTrials
Completed

NCT Number: NCT01415206

The Total Health Study

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.

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Key information

Conditions

Risk Reduction Behavior Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extended Staging Health Risk Intervention (S-HRI)

Behavioral

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

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

  1. Client engagement with behavior change service referrals

    Time frame: Up to18 months follow-up.

Secondary outcomes

  1. Behavioral changes in multiple risks

    Time frame: up to 18 months follow-up.

  2. Improvements in health-related quality of life at 3, 6, 12, and 18 months follow-up.

    Time frame: up to 18 months follow-up.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Extended Care Treatment of Multiple Risk Behaviors in Complex Patients

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Aug 11, 2011
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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