Behavioral Activation for Smoking Cessation in Veterans With PTSD

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01995123
First received: November 20, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.


Condition Intervention
Tobacco Dependence
PTSD
Behavioral: Behavioral Activation Therapy
Behavioral: Health and Smoking Education
Behavioral: Standard Smoking Cessation Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation for Smoking Cessation in Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Abstinence from tobacco [ Time Frame: 26 weeks post target quit date ] [ Designated as safety issue: No ]
    7-day point prevalence abstinence at 26-weeks postquit (measured via single end-point analysis and via abstinence over time).


Secondary Outcome Measures:
  • Time to tobacco relapse [ Time Frame: 26 weeks post target quit date ] [ Designated as safety issue: No ]
    Time to first relapse after target quit date

  • PTSD symptoms [ Time Frame: 5 weeks post target quit date (end of treatment) ] [ Designated as safety issue: No ]
    PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS).


Estimated Enrollment: 120
Study Start Date: March 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Activation Therapy
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Behavioral: Behavioral Activation Therapy
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
Behavioral: Standard Smoking Cessation Therapy
Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
Active Comparator: Health and Smoking Education
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Behavioral: Health and Smoking Education
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
Behavioral: Standard Smoking Cessation Therapy
Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.

Detailed Description:

The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.

After an initial phone screen, in-person screening, and baseline assessment, enrolled participants will be randomized to either behavioral activation therapy and standard smoking cessation treatment (BA+ST) or health and smoking education and standard smoking cessation treatment (HSE+ST). Both groups will meet with a therapist once a week for 8 weeks to receive either BA+ST or HSE+ST. Participants' mood and smoking outcomes will be monitored throughout the 8 weeks of treatment and at 2 follow-up visits and 2 follow-up phone calls.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Report smoking an average of 10 or more cigarettes daily for at least six months
  • Report a desire to quit smoking
  • Meet criteria for current PTSD
  • Speak and read English
  • Agree to participate in the study
  • Be 18 years old
  • Be a veteran

Exclusion Criteria:

  • Meeting criteria for psychotic or bipolar disorder
  • Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
  • Inability to give informed, voluntary, written consent to participate
  • Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
  • Use of non-cigarette tobacco products as a primary form of tobacco use
  • Being currently suicidal or homicidal
  • Being medically unable to use the nicotine patch or nicotine gum/lozenge
  • Psychotropic medication changes within 3 months of study initiation and during active treatment
  • Current engagement in evidence-based therapies for PTSD or depression
  • Pregnant or trying to become pregnant
  • Incarceration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995123

Contacts
Contact: Nasia Safdar, MD PhD (608) 280-7007 Nasia.Safdar@va.gov
Contact: Marvin G Rupp (608) 280-7007 marvin.rupp@va.gov

Locations
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI Not yet recruiting
Madison, Wisconsin, United States, 53705
Contact: Marvin G Rupp    608-280-7007    marvin.rupp@va.gov   
Contact: Nasia Safdar, MD PhD    (608) 280-7007    Nasia.Safdar@va.gov   
Principal Investigator: Jessica Cook, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Jessica Cook, PhD William S. Middleton Memorial Veterans Hospital, Madison, WI
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01995123     History of Changes
Other Study ID Numbers: MHBA-002-12F
Study First Received: November 20, 2013
Last Updated: May 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Tobacco dependence
PTSD
Behavioral Activation Therapy

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 16, 2014