Clinical trial NCT01995123: Behavioral Activation for Smoking Cessation in PTSD
Official title: Behavioral Activation for Smoking Cessation in Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
PTSD
Keywords: Tobacco dependence
PTSD
Behavioral Activation Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Wisconsin, Madison
First posted: 2013-11-26
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Abstained From Smoking
timeFrame: 26 weeks post target quit date
Secondary outcomes:
measure: Time to Smoking Relapse
timeFrame: 26 weeks post target quit date
measure: Clinician Administered PTSD Scale Score
timeFrame: 4 weeks post target quit date (end of treatment)
Other outcomes:
Locations:
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: William S. Middleton Memorial Veterans Hospital, Madison, WI
name: Jessica M Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References: