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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Maryland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00690131
First received: June 2, 2008
Last updated: June 3, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Smoking Cessation
Behavioral: BTSCS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Integrated Approach to Smoking Cessation in SMI

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Smoking abstinence: average percentage of biweekly sessions with negative expired carbon monoxide (CO) levels (< 8 ppm) [ Time Frame: from baseline to post treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690131

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

No publications provided

Responsible Party: Melanie Bennett, Ph.D. (PI), University of Maryland Baltimore, School of Medicine, Department of Psychiatry
ClinicalTrials.gov Identifier: NCT00690131     History of Changes
Other Study ID Numbers: 29891, 1R34MH080814-01A1
Study First Received: June 2, 2008
Last Updated: June 3, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Smoking cessation, severe mental illness, behavioral treatment

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on April 23, 2014