Behavioral Activation for Smoking Cessation in PTSD

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-08

Study Completion Date

2019-03-29

Brief Summary

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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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Detailed Description

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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.

Conditions

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Tobacco Dependence PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral Activation Therapy

Intervention Type 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.

Standard Smoking Cessation Therapy

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Health and Smoking Education

Intervention Type 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

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Standard Smoking Cessation Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes