An Integrated Approach to Smoking Cessation in Severe Mental Illness (SMI)
|ClinicalTrials.gov Identifier: NCT00690131|
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: BTSCS||Not Applicable|
Smoking is the leading cause of preventable death in the United States, contributing to increased rates of lung cancer and heart disease, and adding complications to other health problems. Over 70% of people with serious mental illnesses (SMI) smoke, a rate that is double that of the general population and remains high despite decreases in overall smoking rates. Smoking contributes to elevated morbidity and mortality in SMI, has other life-threatening consequences, and increases health care costs in SMI. While treating smoking is a critical step in improving the health of people with SMI, there are features of SMI that make treatment difficult (low motivation to quit, symptoms, barriers to attendance, cognitive deficits, poor social functioning). Stop-smoking groups have had limited success in achieving smoking cessation (SC), likely because they have not been tailored for people with SMI. SC for SMI must address the deficits and barriers to change found in this population, and must be integrated with mental health services.
This study will involve the design and small-scale clinical trial of a behavioral treatment program for SC in people with SMI called Behavioral Treatment for Smoking Cessation in Serious and Persistent Mental Illness (BTSCS) in two psychosocial rehabilitation programs (PRPs) in Baltimore.
We will first provide basic education for PRP staff regarding smoking cessation in SMI to promote smoking cessation as a goal of mental health treatment. We will then pilot test BTSCS with components that include: (1) A behavioral group emphasizing motivational enhancement, skills training, education, and relapse prevention; (2) Contingency management with financial incentives to reinforce reductions in smoking; (3) Supported use of Bupropion or nicotine replacement therapy that is integrated with clients' psychiatric care in participants who are interested; and (4) Smoking cessation care coordination to increase treatment engagement and retention. Our primary aims are: (1) Develop intervention materials and examine feasibility, acceptability, and safety; (2) Measure the effects of the intervention at post-treatment and 3-month follow-up on rates of smoking cessation, number of quit attempts, rates of smoking reduction and intention/motivation to quit smoking.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||219 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Integrated Approach to Smoking Cessation in SMI|
|Actual Study Start Date :||August 2009|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
BTSCS includes: (1) A behavioral group emphasizing motivational enhancement, skills training, education, and relapse prevention; (2) Contingency management with financial incentives to reinforce reductions in smoking; (3) Supported use of Bupropion or nicotine replacement therapy that is integrated with clients' psychiatric care in participants who are interested; and (4) Smoking cessation care coordination to increase treatment engagement and retention.
|No Intervention: 2|
- Smoking abstinence: percentage of participants reporting abstinence reported in the 7-day interval at post-treatment and follow-up [ Time Frame: 7-day interval at post-treatment and follow-up ]
- Smoking abstinence: average percentage of biweekly sessions with negative expired carbon monoxide (CO) levels (< 8 ppm) [ Time Frame: from baseline to post treatment ]
- Number of smoking quit attempts: self-reported number of quit attempts (for at least 24 hours) at post treatment and 3 month follow-up [ Time Frame: time from baseline to post treatment and baseline to 3 month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690131
|United States, Maryland|
|University of Maryland Baltimore|
|Baltimore, Maryland, United States, 21201|
|Harbor City Unlimited|
|Baltimore, Maryland, United States|
|New Ventures, Sheppard Pratt|
|Timonium, Maryland, United States|
|Principal Investigator:||Melanie E Bennett, Ph.D.||University of Maryland|