Tobacco DependenceNCT01995123
Behavioral Activation for Smoking Cessation in PTSD
A study testing Behavioral Activation Therapy, Health and Smoking Education and Standard Smoking Cessation Therapy in people with Tobacco Dependence and PTSD, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence, PTSD
- What is being tested?
- Behavioral Activation Therapy, Health and Smoking Education and Standard Smoking Cessation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2014to 29 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705
About this study
Official title: Behavioral Activation for Smoking Cessation in Veterans With PTSD
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.
Read the 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.
- Conditions
- Tobacco Dependence, PTSD
- Being tested
- Behavioral Activation Therapy, Health and Smoking Education, Standard Smoking Cessation Therapy
- Keywords
- Tobacco dependence, PTSD, Behavioral Activation Therapy
- Medical subject headings
- Tobacco Use Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation TherapyBehavioural
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 EducationBehavioural
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 TherapyBehavioural
Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation Therapy | Experimental | 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. Receives: Behavioral: Behavioral Activation Therapy; Behavioral: Standard Smoking Cessation Therapy |
| Health and Smoking Education | Active comparator | 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. Receives: Behavioral: Health and Smoking Education; Behavioral: Standard Smoking Cessation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Abstained From Smoking
7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
Measured: 26 weeks post target quit date
Secondary outcomes (2)
Time to Smoking Relapse
Days to first relapse after the target quit date
Measured: 26 weeks post target quit date
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.
Measured: 4 weeks post target quit date (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study start8 Sep 2014
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Jessica M Cook, PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995123
- Sponsor's protocol ID
- MHBA-002-12F
- Status last verified
- Mar 2020
- First submitted
- 20 Nov 2013
- Last updated
- 15 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaye JT, Betts JM, Brubaker E, Webster K, Beckham JC, Baker TB, Cook JW. Behavioral Activation for Smoking Cessation in Veterans with Posttraumatic Stress Disorder: A Randomized Clinical Trial. Nicotine Tob Res. 2025 Aug 22;27(9):1524-1533. doi: 10.1093/ntr/ntaf054.
PubMed 40071390
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation for Smoking Cessation in Veterans With PTSD
- ClinicalTrials.gov ID
- NCT01995123
- Acronym / sponsor ID
- MHBA-002-12F
- Conditions
- Tobacco Dependence, PTSD
- Keywords
- Tobacco dependence, PTSD, Behavioral Activation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Wisconsin, Madison
- Study start
- 8 Sep 2014 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 15 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation Therapy | Experimental | Behavioral: Behavioral Activation Therapy, Behavioral: Standard Smoking Cessation TherapyBehavioral 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. |
| Health and Smoking Education | Active comparator | Behavioral: Health and Smoking Education, Behavioral: Standard Smoking Cessation TherapyHealth 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation TherapyBehavioral 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. | Behavioural | Behavioral Activation Therapy |
| Health and Smoking EducationHealth 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. | Behavioural | Health and Smoking Education |
| Standard Smoking Cessation TherapyStandard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period. | Behavioural | Behavioral Activation Therapy, Health and Smoking Education |
Primary outcome
Percentage of Participants Who Abstained From Smoking
Time frame: 26 weeks post target quit date
7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
2 secondary outcomes
Time to Smoking Relapse
Time frame: 26 weeks post target quit date
Clinician Administered PTSD Scale Score
Time frame: 4 weeks post target quit date (end of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40071390Kaye JT, Betts JM, Brubaker E, Webster K, Beckham JC, Baker TB, Cook JW. Behavioral Activation for Smoking Cessation in Veterans with Posttraumatic Stress Disorder: A Randomized Clinical Trial. Nicotine Tob Res. 2025 Aug 22;27(9):1524-1533. doi: 10.1093/ntr/ntaf054.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica M Cook, PhD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation Therapy, Health and Smoking Education and Standard Smoking Cessation Therapy in people with Tobacco Dependence and PTSD, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Abstained From Smoking (time frame: 26 weeks post target quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01995123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.