NCT00968513

Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 956 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Using a three group additive design, this randomized clinical trial (N=956) aims to evaluate tobacco cessation treatments of varying intensities initiated in the acute psychiatric inpatient setting. The three groups are: 1. Usual Care (N=132) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization; 2. Brief Treatment (N=416) 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=408) 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 nicotine replacement therapy (NRT) with individualized, counselor-delivered motivational and manualized cessation-focused cognitive behavioral counseling (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.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
BEHAVIORAL	Brief Intervention	(N=416) 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
BEHAVIORAL	Extended Treatment	(N=408) 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.
BEHAVIORAL	Usual Care	(N=132) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2009-08-31
• Last updated: 2025-06-11
• Results posted: 2025-06-11

Locations

3 sites across 1 country: United States