Smoking Cessation for Veterans With Severe and Persistent Mental Illness
Condition: Schizoaffective Disorder; Schizophrenia; Affective Psychosis, Bipolar; Affective Disorders, Psychotic
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Mood Disorders; Affective Disorders, Psychotic; Bipolar Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators have developed an intervention called Behavioral Treatment of Smoking
      Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and
      education with contingency management and a multifaceted behavioral group treatment program
      that lasts for three months (24 group meetings). BTSCS is designed to address the cognitive,
      motivational, and social support problems characteristic of people with SPMI.

      The investigators propose to conduct a randomized trial for persons with SPMI that compares
      (1) BTSCS: a 6-month manualized smoking cessation program adapted from an effective substance
      abuse treatment program for this population to (2) StSST: a standard manualized smoking
      cessation program which reflects current best practices.
    

Detailed description: 
      Smoking is the leading cause of preventable death in the United States. Smoking contributes
      to increased rates of diseases such as lung cancer and heart disease, and adds dangerous
      complications to health problems such as diabetes and obesity. Despite widespread recognition
      of the devastating health effects of smoking, over 70% of people with schizophrenia and other
      serious and persistent mental illnesses (SPMI) smoke cigarettes, a rate that is at least
      double that of the general population and remains high despite decreases in rates of smoking
      in the general population. These extraordinary smoking rates contribute to elevated morbidity
      and mortality, have other life-threatening health-related consequences, and increase health
      care costs for treating smoking related illnesses in this population. Treating smoking is
      critical in improving the health of people with SPMI.

      The newly revised VA/Department of Defense Clinical Practice Guideline for the Management of
      Tobacco Use outlines the VHA's comprehensive program for smoking cessation. Beginning in
      1997, the VA central office directed that the Agency for Health Care Policy and Research
      (AHCPR) smoking cessation guideline (the 5 A's - Ask, Advise, Assess, Assist, Arrange) be
      implemented in all its health care facilities. Reinforcing their commitment to increasing
      veterans' access to evidence-based smoking cessation interventions, the VHA recently released
      a new policy mandating that smoking cessation treatment be made available without restriction
      at all VA sites. Our previous study implementing the 5A's in community mental health clinics
      has found reduced smoking and increased use of smoking cessation aids such as nicotine
      replacement therapy (NRT), but no only modest increases in abstinence. Implementation of the
      5 A's was limited by inability to adequately assist patients to stop smoking. Consideration
      of how best to supplement the "Assist" and "Arrange" phases reveals the troubling observation
      that existing "best practice" treatments for smoking cessation have limited effectiveness for
      persons with SPMI. The most widely tested treatments consist generally of adaptations of
      American Lung Association (ALA) or comparable 10-14 session weekly groups supplemented by
      either nicotine replacement therapy (NRT) or Bupropion. Such programs produce low abstinence
      rates (0-25%) at end of intervention. Sustained abstinence is virtually non-existent.
      Abstinence at 6-month or 1-year follow-up points ranges from 0-10%.

      We have developed an intervention the treatment of cocaine and heroin use disorders among
      persons with SPMI, called Behavioral Treatment for Substance Abuse in Serious and Persistent
      Mental Illness (BTSAS). BTSAS was developed with a series of National Institute on Drug Abuse
      (NIDA-funded treatment development grants as a treatment program for substance abuse that
      accommodated the cognitive and motivational impairments that characterize SPMI. The goal was
      to incorporate strategies that have been found to be effective in reducing drug use more
      generally, but to tailor them to meet the needs of people with SPMI. BTSAS provides a model
      for this application's test of an innovative smoking cessation treatment. Our basic premise
      is that we must first acknowledge nicotine dependence as an addiction with characteristics
      common to other substance addictions, and then specify the additional biological, social,
      cognitive, psychological and environmental barriers to quitting smoking for people with SPMI.
      We must then fully optimize available technologies for addiction in general and smoking
      cessation in particular to address these deficits. Existing approaches to smoking cessation
      for persons with SPMI do not use the full range of biological, contingency management, social
      modeling and behavioral tools that have been shown to work in treating other addictions in
      this population. Further, research on treatment of substance use disorders in persons with
      SPMI has suggested that, for best outcomes, interventions may need to be more intensive that
      what is provided for other groups of substance abusers. Applied to smoking, this suggests
      that for people with SPMI, smoking cessation may need to be more intensive than the 9 weekly
      sessions typical of conventional smoking cessation programs.

      Based on our work developing BTSAS, and the above features of smoking in SPMI, we have
      developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS),
      an innovative intervention that supplements pharmacotherapy and education with breath carbon
      monoxide monitoring and a multifaceted behavioral group treatment program that lasts for
      three months (24 sessions). BTSCS is designed to address the cognitive, motivational, and
      social support problems characteristic of people with SPMI. We propose to conduct a
      randomized clinical trial comparing BTSCS to a standard smoking cessation treatment.

      Specific Aims: To determine if BTSCS is more effective in producing abstinence from smoking
      than a manualized smoking cessation program that reflects current best practices (StSST).

      Hypothesis 1: BTSCS will result in greater rates of abstinence than StSST as shown by:

        1. A higher percentage of negative expired carbon monoxide levels at biweekly treatment
           sessions

        2. Increased days of abstinence reported at biweekly treatment sessions

        3. A higher percentage of negative expired carbon monoxide levels immediately
           post-treatment.

        4. A higher percentage of participants reporting abstinence in the 7-day interval preceding
           the post-treatment assessment.

      Secondary Aims: We will assess the effectiveness of BTSCS on a set of intermediate outcomes
      including a reduction in smoking severity and improvement in readiness to quit smoking among
      smokers who have not been able to quit. We will also assess if increased treatment attendance
      and use of NRT's and bupropion moderate the hypothesized increases in abstinence.
    

Intervention name(s): BTSCS; StSST
Intervention type(s): Behavioral; Behavioral
Intervention description(s): BTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.; The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide (CO) test at the start of each group. StSST groups provide education about smoking and support for quitting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation; serious mental illness