Smoking Cessation for Veterans With Severe and Persistent Mental Illness
Randomized Trial of a Smoking Cessation Program for Persons With SMI
1 other identifier
interventional
179
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2010
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 17, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
June 23, 2015
CompletedAugust 18, 2015
July 1, 2015
3.9 years
August 14, 2009
June 5, 2015
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Cigarettes Smoked Per Day
Number of cigarettes smoked per day for the last 7 days
day
Abstinence From Tobacco
Self-reported abstinence from tobacco + breath CO \< 10 ppm
7 days
Study Arms (2)
BTSCS
EXPERIMENTALBTSCS 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.
StSST
ACTIVE COMPARATORThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Documented history of severe neurological disorder or severe head trauma with loss of consciousness
- Severe or profound mental retardation by chart review.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422, United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
Related Publications (1)
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.
PMID: 26457385DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The sample was mostly male, African-American, and recruited at VAMCs; it is unclear if findings would generalize to community settings. Many declined to participate; the sample represents persons with SMI who are interested in quitting.
Results Point of Contact
- Title
- Dr. Melanie Bennett, Research Health Scientist
- Organization
- V Maryland Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie E Bennett
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 17, 2009
Study Start
April 1, 2010
Primary Completion
March 1, 2014
Study Completion
December 1, 2014
Last Updated
August 18, 2015
Results First Posted
June 23, 2015
Record last verified: 2015-07