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Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

2014-07-23 21:13:30 | BioPortfolio

Summary

This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.

Description

Using a three group additive design, this randomized clinical trial (N=1100) aims to evaluate tobacco cessation treatments of varying intensities initiated in the acute psychiatric inpatient setting. The three groups are:

1. Usual Care (N=150) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization;

2. Brief Treatment (N=475) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization;

3. Extended Treatment (N=475) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.

This study seeks to determine: (i) whether the initial successes seen in an academic-based psychiatric hospital can be replicated in a larger and more diverse patient population; and (ii) if more extended and intensive treatment combining NRT with individualized, counselor-delivered motivational and manualized cessation-focused CBT can outperform our current best practices. Ultimately, this research could lead to a model smoking cessation intervention for smokers with severe mental illness and, more generally, may provide a useful model for understanding the nature and complexity of intervening on comorbidities.

We hypothesize that the extended treatment will outperform the brief treatment, and that both treatment groups will be more effective than usual care in producing quit attempts and ultimately abstinence from cigarettes. Secondary specific aims will model the cost-effectiveness and budgetary impacts of the treatment conditions; examine moderators and mediators of treatment outcomes; and prospectively examine the relation between changes in smoking, mental health functioning, and use of other substances over time.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Tobacco Dependence

Intervention

Brief Intervention, Extended Treatment, Usual Care

Location

Alta Bates Summit Medical Center
Berkeley
California
United States
94704

Status

Recruiting

Source

National Institute of Mental Health (NIMH)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:30-0400

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Medical and Biotech [MESH] Definitions

The absence of a useful purpose or useful result in a diagnostic procedure or therapeutic intervention. The situation of a patient whose condition will not be improved by treatment or instances in which treatment preserves permanent unconsciousness or cannot end dependence on intensive medical care. (From Ann Intern Med 1990 Jun 15;112(12):949)

Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.

First aid or other immediate intervention for accidents or medical conditions requiring immediate care and treatment before definitive medical and surgical management can be procured.

Care over an extended period, usually for a chronic condition or disability, requiring periodic, intermittent, or continuous care.

The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.

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