Behavioral Activation for Smoking Cessation in PTSD

VA Office of Research and Development

Status: Completed

Conditions: Tobacco Dependence; PTSD

Treatments: Behavioral: Health and Smoking Education; Behavioral: Behavioral Activation Therapy; Behavioral: Standard Smoking Cessation Therapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01995123

MHBA-002-12F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Behavioral Activation Therapy

Experimental group

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.

Treatment:

Behavioral: Standard Smoking Cessation Therapy

Behavioral: Behavioral Activation Therapy

Health and Smoking Education

Active Comparator group

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.

Treatment:

Behavioral: Health and Smoking Education

Behavioral: Standard Smoking Cessation Therapy