Smoking Cessation for Veterans With Severe and Persistent Mental Illness

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00960375
First received: August 14, 2009
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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 sessions). 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 ALA-based manualized smoking cessation program which reflects current best practices.


Condition Intervention Phase
Schizoaffective Disorder
Schizophrenia
Mood Disorders With Psychotic Features
Behavioral: BTSCS
Behavioral: StSST
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of a Smoking Cessation Program for Persons With SMI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Expired CO [ Time Frame: 8-10 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported abstinence from Tobacco [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (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 sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (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: Arm 2
The StSST program was 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 meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
Behavioral: StSST
The StSST program was 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 meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960375

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
Investigators
Principal Investigator: Melanie E Bennett Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00960375     History of Changes
Other Study ID Numbers: NURA-001-09S
Study First Received: August 14, 2009
Last Updated: February 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
smoking cessation
serious mental illness

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Smoking
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Habits

ClinicalTrials.gov processed this record on April 23, 2014