Behavioral Activation for Smoking Cessation in PTSD

Behavioral Activation for Smoking Cessation in Veterans With PTSD

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Tobacco Dependence
• Intervention / Treatment: Behavioral: Behavioral Activation Therapy; Behavioral: Standard Smoking Cessation Therapy; Behavioral: Health and Smoking Education

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: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • William S. Middleton Memorial Veterans Hospital, Madison, WI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Standard Smoking Cessation Therapy; Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Abstained From Smoking	7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day	26 weeks post target quit date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Smoking Relapse	Days to first relapse after the target quit date	26 weeks post target quit date
Clinician Administered PTSD Scale Score	PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms.	4 weeks post target quit date (end of treatment)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Wisconsin, Madison
• Investigators: Principal Investigator: Jessica M Cook, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2014
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): March 29, 2019

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: PTSD; Behavioral Activation Therapy; Tobacco dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: MHBA-002-12F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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