Smoking Cessation for Veterans With Severe and Persistent Mental Illness

• ClinicalTrials.gov Identifier: NCT00960375
• Recruitment Status: Completed
• First Posted: August 17, 2009
• Results First Posted: June 23, 2015
• Last Update Posted: August 18, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Schizoaffective Disorder; Schizophrenia; Affective Psychosis, Bipolar; Affective Disorders, Psychotic	Behavioral: BTSCS; Behavioral: StSST	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 179 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Trial of a Smoking Cessation Program for Persons With SMI
• Study Start Date: April 2010
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: BTSCS; 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.	Behavioral: BTSCS; 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.
Active Comparator: StSST; 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 test at the start of each group meeting. StSST groups provide education about smoking and support for quitting.	Behavioral: StSST; 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Cigarettes Smoked Per Day [ Time Frame: day ]
   Number of cigarettes smoked per day for the last 7 days
2. Abstinence From Tobacco [ Time Frame: 7 days ]
   Self-reported abstinence from tobacco + breath CO < 10 ppm

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• DSM-IV diagnosis of severe and persistent mental illness (SPMI) including a diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC) -Schizophrenic disorders, affective psychoses and other psychotic diagnoses. We also include individuals with a diagnosis of Major Depression with psychotic features and PTSD.
• Age 18-75
• Nicotine dependence as defined by a score of 5 or higher on the Fagerstrom Tolerance Scale OR Participants who currently smoke at least 10 cigarettes per day
• Participants will not meet criteria for current alcohol/substance dependence (other than nicotine)
• Willingness ability to provide consent to participate.

Exclusion Criteria:

• Documented history of severe neurological disorder or severe head trauma with loss of consciousness
• Severe or profound mental retardation by chart review.

Contacts and Locations

Locations

United States, District of Columbia

Washington DC VA Medical Center, Washington, DC

Washington, District of Columbia, United States, 20422

United States, Maryland

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

• Principal Investigator: Melanie E Bennett; Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bennett ME, Brown CH, Li L, Himelhoch S, Bellack A, Dixon L. Smoking Cessation in Individuals With Serious Mental Illness: A Randomized Controlled Trial of Two Psychosocial Interventions. J Dual Diagn. 2015;11(3-4):161-73. doi: 10.1080/15504263.2015.1104481.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00960375
• Other Study ID Numbers: NURA-001-09S
• First Posted: August 17, 2009
• Results First Posted: June 23, 2015
• Last Update Posted: August 18, 2015
• Last Verified: July 2015

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

smoking cessation; serious mental illness

Additional relevant MeSH terms:

Disease; Schizophrenia; Psychotic Disorders; Mental Disorders; Mood Disorders; Affective Disorders, Psychotic; Bipolar Disorder; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders