Behavioral Activation for Smoking Cessation in PTSD

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01995123
• Collaborator: University of Wisconsin, Madison (Other)
• Enrollment: 124
• Location: 1
• Arms: 2
• Actual Duration (Months): 54.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Dependence; PTSD	Behavioral: Behavioral Activation Therapy; Behavioral: Health and Smoking Education; Behavioral: Standard Smoking Cessation Therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Behavioral Activation for Smoking Cessation in Veterans With PTSD
• Actual Study Start Date: Sep 8, 2014
• Actual Primary Completion Date: Mar 29, 2019
• Actual Study Completion Date: Mar 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.; Behavioral: Standard Smoking Cessation Therapy; Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
Active Comparator: 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.	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.; Behavioral: Standard Smoking Cessation Therapy; Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.

Outcome Measures

Primary Outcome Measures

1. 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

1. Time to Smoking Relapse [26 weeks post target quit date]

   Days to first relapse after the target quit date

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

• VA Office of Research and Development
• University of Wisconsin, Madison

Investigators

• Principal Investigator: Jessica M Cook, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 5, 2015

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01995123
• Other Study ID Numbers: MHBA-002-12F; NCT01947725
• First Posted: Nov 26, 2013
• Last Update Posted: Apr 15, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Tobacco dependence; PTSD; Behavioral Activation Therapy
• Additional relevant MeSH terms: Tobacco Use Disorder

Study Results

Participant Flow

Arm/Group Title	Behavioral Activation Therapy	Health and Smoking Education
Arm/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. 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. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.	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: 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.
Period Title: Overall Study
STARTED	63	61
COMPLETED	45	46
NOT COMPLETED	18	15

Baseline Characteristics

Arm/Group Title	Behavioral Activation Therapy	Health and Smoking Education	Total
Arm/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. 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. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.	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: 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.	Total of all reporting groups
Overall Participants	63	61	124
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	55 87.3%	54 88.5%	109 87.9%
>=65 years	6 9.5%	6 9.8%	12 9.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.70 (12.01)	47.17 (13.02)	48.95 (12.59)
Sex: Female, Male (Count of Participants)
Female	11 17.5%	4 6.6%	15 12.1%
Male	52 82.5%	57 93.4%	109 87.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.2%	2 3.3%	4 3.2%
Not Hispanic or Latino	61 96.8%	59 96.7%	120 96.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.6%	1 1.6%	2 1.6%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	1 1.6%	0 0%	1 0.8%
Black or African American	4 6.3%	7 11.5%	11 8.9%
White	54 85.7%	52 85.2%	106 85.5%
More than one race	2 3.2%	1 1.6%	3 2.4%
Unknown or Not Reported	1 1.6%	0 0%	1 0.8%
Region of Enrollment (Count of Participants)
United States	63 100%	61 100%	124 100%
Baseline cigarettes smoked per day (Cigarettes per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Cigarettes per day]	18.67 (7.26)	17.34 (8.26)	17.99 (7.78)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Activation Therapy	Health and Smoking Education
Arm/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. 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. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.	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: 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.
Measure Participants	63	61
Week 4	23 36.5%	21 34.4%
Week 12	20 31.7%	19 31.1%
Week 20	22 34.9%	14 23%
Week 26	12 19%	8 13.1%

2. Secondary Outcome

Title	Time to Smoking Relapse
Description	Days to first relapse after the target quit date
Time Frame	26 weeks post target quit date

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Activation Therapy	Health and Smoking Education
Arm/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. 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. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.	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: 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.
Measure Participants	63	61
Mean (Standard Deviation) [Days]	88.41 (73.46)	84.34 (72.29)

3. Secondary Outcome

Title	Clinician Administered PTSD Scale Score
Description	PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms.
Time Frame	4 weeks post target quit date (end of treatment)

Outcome Measure Data

Analysis Population Description

Outcome Measure assessed at separate study visit. Data reported for participants who were assessed at this visit.

Arm/Group Title	Behavioral Activation Therapy	Health and Smoking Education
Arm/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. 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. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.	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: 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.
Measure Participants	46	45
Mean (Standard Deviation) [Units on a scale]	30.78 (11.80)	27.33 (13.29)

Adverse Events

Time Frame	Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Adverse Event Reporting Description	Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
Arm/Group Title	Behavioral Activation Therapy		Health and Smoking Education
Arm/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. 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. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.		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: 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.
All Cause Mortality
	Behavioral Activation Therapy		Health and Smoking Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/63 (1.6%)		1/61 (1.6%)
Serious Adverse Events
	Behavioral Activation Therapy		Health and Smoking Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/63 (11.1%)		6/61 (9.8%)
Cardiac disorders
Hospitalized for chest pain	1/63 (1.6%)	1	0/61 (0%)	0
General disorders
Hospitalized for fall	0/63 (0%)	0	1/61 (1.6%)	1
Death	1/63 (1.6%)	1	1/61 (1.6%)	1
Musculoskeletal and connective tissue disorders
Hospitalized for back pain	1/63 (1.6%)	1	0/61 (0%)	0
Nervous system disorders
Hospitalized for lightheadedness	1/63 (1.6%)	1	0/61 (0%)	0
Hospitalized for TIA	0/63 (0%)	0	1/61 (1.6%)	1
Psychiatric disorders
Hospitalized for suicidal ideation	0/63 (0%)	0	2/61 (3.3%)	2
Respiratory, thoracic and mediastinal disorders
Hospitalized for shortness of breath	2/63 (3.2%)	3	0/61 (0%)	0
Hospitalized for pneumonia	1/63 (1.6%)	1	0/61 (0%)	0
Surgical and medical procedures
Hospitalized for wound care	0/63 (0%)	0	1/61 (1.6%)	1
Other (Not Including Serious) Adverse Events
	Behavioral Activation Therapy		Health and Smoking Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/63 (52.4%)		29/61 (47.5%)
Gastrointestinal disorders
Nausea	3/63 (4.8%)	3	4/61 (6.6%)	4
Hiccups	2/63 (3.2%)	2	2/61 (3.3%)	2
Persistent indigestion	8/63 (12.7%)	9	6/61 (9.8%)	7
Nervous system disorders
Dizziness	0/63 (0%)	0	4/61 (6.6%)	4
Headache	5/63 (7.9%)	7	8/61 (13.1%)	11
Psychiatric disorders
Insomnia	2/63 (3.2%)	2	5/61 (8.2%)	10
Vivid dreams	10/63 (15.9%)	13	4/61 (6.6%)	10
Skin and subcutaneous tissue disorders
Itching	10/63 (15.9%)	10	11/61 (18%)	11
Swelling or tingling of the mouth	4/63 (6.3%)	4	1/61 (1.6%)	3
Skin rash	7/63 (11.1%)	8	2/61 (3.3%)	4
Mouth problems	2/63 (3.2%)	4	1/61 (1.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.