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Behavioral Activation for Smoking Cessation in PTSD

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ClinicalTrials.gov Identifier: NCT01995123
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE November 20, 2013
First Posted Date  ICMJE November 26, 2013
Results First Submitted Date  ICMJE March 31, 2020
Results First Posted Date  ICMJE April 15, 2020
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE September 8, 2014
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
Percentage of Participants Who Abstained From Smoking [ Time Frame: 26 weeks post target quit date ]
7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
  • Time to Smoking Relapse [ Time Frame: 26 weeks post target quit date ]
    Days to first relapse after the target quit date
  • Clinician Administered PTSD Scale Score [ Time Frame: 4 weeks post target quit date (end of treatment) ]
    PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral Activation for Smoking Cessation in PTSD
Official Title  ICMJE Behavioral Activation for Smoking Cessation in Veterans With PTSD
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tobacco Dependence
  • PTSD
Intervention  ICMJE
  • 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: 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Behavioral Activation Therapy
    • Behavioral: Standard Smoking Cessation Therapy
  • 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.
    Interventions:
    • Behavioral: Health and Smoking Education
    • Behavioral: Standard Smoking Cessation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
124
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
120
Actual Study Completion Date  ICMJE March 29, 2019
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995123
Other Study ID Numbers  ICMJE MHBA-002-12F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE University of Wisconsin, Madison
Investigators  ICMJE
Principal Investigator: Jessica M Cook, PhD William S. Middleton Memorial Veterans Hospital, Madison, WI
PRS Account VA Office of Research and Development
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP