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Behavioral Activation for Smoking Cessation in PTSD

Primary Purpose

Tobacco Dependence, PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation Therapy
Health and Smoking Education
Standard Smoking Cessation Therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring Tobacco dependence, PTSD, Behavioral Activation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Activation Therapy

Health and Smoking Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to Smoking Relapse
Days to first relapse after the 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.

Full Information

First Posted
November 20, 2013
Last Updated
March 31, 2020
Sponsor
VA Office of Research and Development
Collaborators
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01995123
Brief Title
Behavioral Activation for Smoking Cessation in PTSD
Official Title
Behavioral Activation for Smoking Cessation in Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 8, 2014 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
March 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Wisconsin, Madison

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, PTSD
Keywords
Tobacco dependence, PTSD, Behavioral Activation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Activation Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Health and Smoking Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health and Smoking Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Smoking Cessation Therapy
Intervention Description
Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Abstained From Smoking
Description
7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
Time Frame
26 weeks post target quit date
Secondary Outcome Measure Information:
Title
Time to Smoking Relapse
Description
Days to first relapse after the target quit date
Time Frame
26 weeks post target quit date
Title
Clinician Administered PTSD Scale Score
Description
PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms.
Time Frame
4 weeks post target quit date (end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica M Cook, PhD
Organizational Affiliation
William S. Middleton Memorial Veterans Hospital, Madison, WI
Official's Role
Principal Investigator
Facility Information:
Facility Name
William S. Middleton Memorial Veterans Hospital, Madison, WI
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Behavioral Activation for Smoking Cessation in PTSD

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