An Integrated Approach to Smoking Cessation in Severe Mental Illness (SMI)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This 3-year study will involve the design and small-scale clinical trial of a behavioral treatment program for smoking cessation in people with severe mental illness (called Behavioral Treatment for Smoking Cessation in Serious and Persistent Mental Illness or BTSCS) in two psychosocial rehabilitation programs (PRPs) in Baltimore. Our 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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: BTSCS	Not Applicable

Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	219 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1	Behavioral: BTSCS; 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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
2. Smoking abstinence: average percentage of biweekly sessions with negative expired carbon monoxide (CO) levels (< 8 ppm) [ Time Frame: from baseline to post treatment ]
3. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Severe and Persistent Mental Illness (schizophrenia, schizoaffective disorder or other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder).
• Age between 18 and 75 years.
• Current smokers who smoke at least 10 cigarettes per day.
• Must have been seen by a psychiatrist at least every 3 months for the last 6 months.

Exclusion Criteria:

• Meet criteria for current alcohol/substance dependence (other than nicotine).
• Documented mental retardation, history of severe head injury with LOC, severe and untreated seizure disorder

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Maryland

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Melanie E Bennett, Ph.D.	University of Maryland

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00690131 History of Changes
Other Study ID Numbers:	HP-00043121; 1R34MH080814-01A1 ( U.S. NIH Grant/Contract )
First Posted:	June 4, 2008
Last Update Posted:	March 30, 2017
Last Verified:	March 2017

Keywords provided by University of Maryland:

Smoking cessation, severe mental illness, behavioral treatment