Behavioral Activation for Smoking Cessation in PTSD

N/ACompletedNCT01995123

VA Office of Research and Development124 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

124

Conditions

Tobacco Dependence PTSD

Interventions

Behavioral Activation TherapyBEHAVIORAL

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 EducationBEHAVIORAL

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 TherapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Abstained From Smoking

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 Outcomes

Time to Smoking Relapse

Days to first relapse after the target quit date

Time frame: 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.

Time frame: 4 weeks post target quit date (end of treatment)

Data from ClinicalTrials.gov

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