Tobacco Dependence, PTSD
Conditions
Keywords
Tobacco dependence, PTSD, Behavioral Activation Therapy
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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALHealth 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.
BEHAVIORALStandard Smoking Cessation Therapy
Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
Sponsors
University of Wisconsin, Madison
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 63 |
| 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: 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. | 61 |
| Total | 124 |
Baseline characteristics
| Characteristic | Behavioral Activation Therapy | Health and Smoking Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 54 Participants | 109 Participants |
| Age, Continuous | 50.70 years STANDARD_DEVIATION 12.01 | 47.17 years STANDARD_DEVIATION 13.02 | 48.95 years STANDARD_DEVIATION 12.59 |
| Baseline cigarettes smoked per day | 18.67 Cigarettes per day STANDARD_DEVIATION 7.26 | 17.34 Cigarettes per day STANDARD_DEVIATION 8.26 | 17.99 Cigarettes per day STANDARD_DEVIATION 7.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 59 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 54 Participants | 52 Participants | 106 Participants |
| Region of Enrollment United States | 63 Participants | 61 Participants | 124 Participants |
| Sex: Female, Male Female | 11 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Male | 52 Participants | 57 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 63 | 1 / 61 |
| other Total, other adverse events | 33 / 63 | 29 / 61 |
| serious Total, serious adverse events | 7 / 63 | 6 / 61 |
Outcome results
Primary
Percentage of Participants Who Abstained From Smoking
7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
Time frame: 26 weeks post target quit date
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Activation Therapy | Percentage of Participants Who Abstained From Smoking | Week 4 | 23 Participants |
| Behavioral Activation Therapy | Percentage of Participants Who Abstained From Smoking | Week 12 | 20 Participants |
| Behavioral Activation Therapy | Percentage of Participants Who Abstained From Smoking | Week 20 | 22 Participants |
| Behavioral Activation Therapy | Percentage of Participants Who Abstained From Smoking | Week 26 | 12 Participants |
| Health and Smoking Education | Percentage of Participants Who Abstained From Smoking | Week 26 | 8 Participants |
| Health and Smoking Education | Percentage of Participants Who Abstained From Smoking | Week 20 | 14 Participants |
| Health and Smoking Education | Percentage of Participants Who Abstained From Smoking | Week 4 | 21 Participants |
| Health and Smoking Education | Percentage of Participants Who Abstained From Smoking | Week 12 | 19 Participants |
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.
Time frame: 4 weeks post target quit date (end of treatment)
Population: Outcome Measure assessed at separate study visit. Data reported for participants who were assessed at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation Therapy | Clinician Administered PTSD Scale Score | 30.78 Units on a scale | Standard Deviation 11.8 |
| Health and Smoking Education | Clinician Administered PTSD Scale Score | 27.33 Units on a scale | Standard Deviation 13.29 |
Secondary
Time to Smoking Relapse
Days to first relapse after the target quit date
Time frame: 26 weeks post target quit date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation Therapy | Time to Smoking Relapse | 88.41 Days | Standard Deviation 73.46 |
| Health and Smoking Education | Time to Smoking Relapse | 84.34 Days | Standard Deviation 72.29 |