Clinical trial NCT00690131: An Integrated Approach to Smoking Cessation in Severe Mental Illness (SMI)
Official title: An Integrated Approach to Smoking Cessation in SMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation, severe mental illness, behavioral treatment
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-06-04
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Smoking abstinence: percentage of participants reporting abstinence reported in the 7-day interval at post-treatment and follow-up
timeFrame: 7-day interval at post-treatment and follow-up
measure: Smoking abstinence: average percentage of biweekly sessions with negative expired carbon monoxide (CO) levels (< 8 ppm)
timeFrame: from baseline to post treatment
measure: Number of smoking quit attempts: self-reported number of quit attempts (for at least 24 hours) at post treatment and 3 month follow-up
timeFrame: time from baseline to post treatment and baseline to 3 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Harbor City Unlimited
state: Maryland
city: Timonium
country: United States
facility: New Ventures, Sheppard Pratt
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Melanie E Bennett, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: