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

Smoking Cessation Clinical Trial

Official title:

An Integrated Approach to Smoking Cessation in SMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690131
• Other study ID #: HP-00043121
• Secondary ID: 1R34MH080814-01A
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: May 2015

Study information

• Verified date: April 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	Harbor City Unlimited	Baltimore	Maryland
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	New Ventures, Sheppard Pratt	Timonium	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence: percentage of participants reporting abstinence reported in the 7-day interval at post-treatment and follow-up		7-day interval at post-treatment and follow-up
Primary	Smoking abstinence: average percentage of biweekly sessions with negative expired carbon monoxide (CO) levels (< 8 ppm)		from baseline to post treatment
Primary	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 from baseline to post treatment and baseline to 3 month follow-up