Behavioral Activation for Smoking Cessation in PTSD

Not Applicable

Completed

• Conditions: Tobacco Dependence; PTSD
• Interventions: Behavioral: Behavioral Activation Therapy; Behavioral: Health and Smoking Education; Behavioral: Standard Smoking Cessation Therapy

• Registration Number: NCT01995123
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-26
• Study Start: 2014-09-08
• Primary Completion: 2019-03-29
• Study Completion: 2019-03-29
• Status Verified: 2020-03
• Results First Submitted: 2020-03-31
• Results First Submitted QC: 2020-03-31
• Last Update Submitted: 2020-03-31
• Results First Posted: 2020-04-15
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Activation Therapy	Standard Smoking Cessation 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.
Behavioral Activation Therapy	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.
Health and Smoking Education	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.
Health and Smoking Education	Standard Smoking Cessation Therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to Smoking Relapse	26 weeks post target quit date	Days to first relapse after the target quit date
Clinician Administered PTSD Scale Score	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.

Trial Locations

Locations (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI; 🇺🇸 Madison, Wisconsin, United States