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Behavioral Activation for Smoking Cessation in PTSD

This study is currently recruiting participants.
Verified July 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT01995123
First Posted: November 26, 2013
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Parallel Assignment
Masking: Double (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 VA Office of Research and Development:

Primary Outcome Measures:
  • Abstinence from tobacco [ Time Frame: 26 weeks post target quit date ]
    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 ]
    Time to first relapse after target quit date

  • PTSD symptoms [ Time Frame: 5 weeks post target quit date (end of treatment) ]
    PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS).


Estimated Enrollment: 120
Actual Study Start Date: September 8, 2014
Estimated Study Completion Date: December 28, 2018
Estimated Primary Completion Date: December 28, 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995123


Contacts
Contact: Aaron F Heneghan, PhD (608) 256-1901 ext 17801 Aaron.Heneghan@va.gov

Locations
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI Recruiting
Madison, Wisconsin, United States, 53705
Contact: Aaron F Heneghan, PhD    608-256-1901 ext 17801    Aaron.Heneghan@va.gov   
Principal Investigator: Jessica M Cook, PhD         
Sponsors and Collaborators
VA Office of Research and Development
University of Wisconsin, Madison
Investigators
Principal Investigator: Jessica M Cook, PhD William S. Middleton Memorial Veterans Hospital, Madison, WI
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01995123     History of Changes
Obsolete Identifiers: NCT01947725
Other Study ID Numbers: MHBA-002-12F
First Submitted: November 20, 2013
First Posted: November 26, 2013
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Tobacco dependence
PTSD
Behavioral Activation Therapy

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