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Behavioral Activation for Smoking Cessation in PTSD

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ClinicalTrials.gov Identifier: NCT01995123
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Tobacco Dependence
PTSD
Interventions Behavioral: Behavioral Activation Therapy
Behavioral: Health and Smoking Education
Behavioral: Standard Smoking Cessation Therapy
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Behavioral Activation Therapy Health and Smoking Education
Hide 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
Arm/Group Title Behavioral Activation Therapy Health and Smoking Education Total
Hide 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 Number of Baseline Participants 63 61 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
55
  90.2%
54
  90.0%
109
  90.1%
>=65 years
6
   9.8%
6
  10.0%
12
   9.9%
[1]
Measure Analysis Population Description: Missing age data from three participants.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 60 participants 121 participants
50.70  (12.01) 47.17  (13.02) 48.95  (12.59)
[1]
Measure Analysis Population Description: Missing age data from three participants.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 61 participants 124 participants
Female
11
  17.5%
4
   6.6%
15
  12.1%
Male
52
  82.5%
57
  93.4%
109
  87.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 61 participants 124 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%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 61 participants 124 participants
American Indian or Alaska Native
1
   1.6%
1
   1.6%
2
   1.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.6%
0
   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
   0.0%
1
   0.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 63 participants 61 participants 124 participants
63
 100.0%
61
 100.0%
124
 100.0%
Baseline cigarettes smoked per day  
Mean (Standard Deviation)
Unit of measure:  Cigarettes per day
Number Analyzed 63 participants 61 participants 124 participants
18.67  (7.26) 17.34  (8.26) 17.99  (7.78)
1.Primary Outcome
Title Percentage of Participants Who Abstained From Smoking
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Therapy Health and Smoking Education
Hide 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.

Overall Number of Participants Analyzed 63 61
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4
23
  36.5%
21
  34.4%
Week 12
20
  31.7%
19
  31.1%
Week 20
22
  34.9%
14
  23.0%
Week 26
12
  19.0%
8
  13.1%
2.Secondary Outcome
Title Time to Smoking Relapse
Hide Description Days to first relapse after the target quit date
Time Frame 26 weeks post target quit date
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Therapy Health and Smoking Education
Hide 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.

Overall Number of Participants Analyzed 63 61
Mean (Standard Deviation)
Unit of Measure: Days
88.41  (73.46) 84.34  (72.29)
3.Secondary Outcome
Title Clinician Administered PTSD Scale Score
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: Units on a scale
30.78  (11.80) 27.33  (13.29)
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
Hide 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 (%) Affected / at Risk (%)
Total   1/63 (1.59%)      1/61 (1.64%)    
Hide Serious Adverse Events
Behavioral Activation Therapy Health and Smoking Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/63 (11.11%)      6/61 (9.84%)    
Cardiac disorders     
Hospitalized for chest pain *  1/63 (1.59%)  1 0/61 (0.00%)  0
General disorders     
Hospitalized for fall *  0/63 (0.00%)  0 1/61 (1.64%)  1
Death *  1/63 (1.59%)  1 1/61 (1.64%)  1
Musculoskeletal and connective tissue disorders     
Hospitalized for back pain *  1/63 (1.59%)  1 0/61 (0.00%)  0
Nervous system disorders     
Hospitalized for lightheadedness *  1/63 (1.59%)  1 0/61 (0.00%)  0
Hospitalized for TIA *  0/63 (0.00%)  0 1/61 (1.64%)  1
Psychiatric disorders     
Hospitalized for suicidal ideation *  0/63 (0.00%)  0 2/61 (3.28%)  2
Respiratory, thoracic and mediastinal disorders     
Hospitalized for shortness of breath *  2/63 (3.17%)  3 0/61 (0.00%)  0
Hospitalized for pneumonia *  1/63 (1.59%)  1 0/61 (0.00%)  0
Surgical and medical procedures     
Hospitalized for wound care *  0/63 (0.00%)  0 1/61 (1.64%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Behavioral Activation Therapy Health and Smoking Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/63 (52.38%)      29/61 (47.54%)    
Gastrointestinal disorders     
Nausea   3/63 (4.76%)  3 4/61 (6.56%)  4
Hiccups   2/63 (3.17%)  2 2/61 (3.28%)  2
Persistent indigestion   8/63 (12.70%)  9 6/61 (9.84%)  7
Nervous system disorders     
Dizziness   0/63 (0.00%)  0 4/61 (6.56%)  4
Headache   5/63 (7.94%)  7 8/61 (13.11%)  11
Psychiatric disorders     
Insomnia   2/63 (3.17%)  2 5/61 (8.20%)  10
Vivid dreams   10/63 (15.87%)  13 4/61 (6.56%)  10
Skin and subcutaneous tissue disorders     
Itching   10/63 (15.87%)  10 11/61 (18.03%)  11
Swelling or tingling of the mouth   4/63 (6.35%)  4 1/61 (1.64%)  3
Skin rash   7/63 (11.11%)  8 2/61 (3.28%)  4
Mouth problems   2/63 (3.17%)  4 1/61 (1.64%)  1
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jessica Cook, PhD
Organization: Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health; William S Middleton Memorial Veterans Hospital
Phone: 608-265-9775
EMail: jwcook@ctri.wisc.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01995123    
Obsolete Identifiers: NCT01947725
Other Study ID Numbers: MHBA-002-12F
First Submitted: November 20, 2013
First Posted: November 26, 2013
Results First Submitted: March 31, 2020
Results First Posted: April 15, 2020
Last Update Posted: April 15, 2020