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Completed

NCT Number: NCT01995123

Behavioral Activation for Smoking Cessation in 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.

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Key information

Conditions

Tobacco Dependence Chemically-Induced Disorders Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Tobacco Use Disorder Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral activation therapy

Behavioral

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.

Health and Smoking Education

Behavioral

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.

Standard Smoking Cessation Therapy

Behavioral

Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to Smoking Relapse

    Time frame: 26 weeks post target quit date

    Days to first relapse after the target quit date

  2. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Wisconsin, Madison

Registry information

Official study title

Behavioral Activation for Smoking Cessation in Veterans With PTSD

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2013
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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