Behavioral Activation for Smoking Cessation in PTSD

PTSD Clinical Trial

Official title:

Behavioral Activation for Smoking Cessation in Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995123
• Other study ID #: MHBA-002-12F
• Status: Completed
• Phase: N/A
• Start date: September 8, 2014
• Est. completion date: March 29, 2019

Study information

• Verified date: March 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01947725

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 29, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• 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.
• 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.
• Standard Smoking Cessation Therapy
Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.

Locations

Country	Name	City	State
United States	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Abstained From Smoking	7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day	26 weeks post target quit date
Secondary	Time to Smoking Relapse	Days to first relapse after the target quit date	26 weeks post target quit date
Secondary	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.	4 weeks post target quit date (end of treatment)