Smoking Termination / Anxiety Reduction Treatment (ST/ART) (START)
April 19, 2019 updated by: Michael J. Zvolensky, Ph.D., University of Houston
Augmenting Smoking Cessation With Transdiagnostic CBT for Smokers With Anxiety
The primary aim of this research study is to enhance smoking cessation outcome among smokers with anxiety disorders.
The investigators are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation and anxiety treatment program (START).
Both treatments also utilize nicotine replacement therapy.
Study Overview
Status
Completed
Conditions
Detailed Description
The chief objective of the proposed study is to develop an integrated standard smoking cessation treatment and transdiagnostic anxiety disorder treatment for smokers with anxiety disorders.
The intervention is designed to promote smoking cessation and reduce (a) anxiety symptoms, (b) depression, and (c) the cognitive factor of AS, thereby reducing three notable emotional risk factors of smoking cessation relapse, while at the same time targeting (d) nicotine withdrawal symptoms.
The intervention development approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral therapies.
During the first year, startup activities will include piloting the integrated intervention on a subset of individuals, soliciting internal and external expert consultant and participant feedback, and development of the final treatment protocol.
The goal during this phase of the project will be to establish feasibility of treatment delivery, participant acceptability, and potential for an effect.
During the following two years, a pilot two-arm efficacy study will be undertaken.
The two arms of the randomized trial (RCT) will be: (a) the integrated smoking cessation treatment, consisting of a standard smoking cessation intervention (i.e., CBT-Smoking + Nicotine Replacement Therapy [NRT]) plus a transdiagnostic CBT for anxiety (Smoking Termination and Anxiety Reduction Treatment; START) or (b) standard smoking cessation intervention (i.e., CBT-Smoking + NRT) plus contact control (ST+CTRL).
The primary outcomes will be short- and long-term point prevalence abstinence (PPA) and time to first smoking lapse and relapse.
The following specific aims are proposed: 1.
To compare, in a pilot RCT, the effects of START vs. ST+CTRL on smoking cessation outcomes: Short- and longterm PPA.
The investigators expect that PPA will be higher, both in the short- and longterm, for those in the START condition compared to those in ST+CTRL.
Similarly, The investigators expect the rate of decline in abstinence over time to be slower in START than in ST+CTRL Time to first smoking lapse and time to smoking relapse.
The investigators expect mean time to first lapse and to relapse to be greater for those in the START compared to those in the ST+CTRL condition.
2. To compare, in a pilot RCT, the effect of START vs. ST+CTRL on the remission of anxiety disorders, anxiety and depressive symptoms, anxiety sensitivity, and nicotine withdrawal symptoms.
3. To explore the mechanisms by which START improves smoking cessation.
The investigators expect that: Treatments over time will directly cause changes in abstinence and withdrawal symptoms, AS, anxiety symptoms, depressed mood (i.e., the proposed mediators of change in abstinence); The effect of treatment on anxiety symptoms and depressed mood will be moderated by treatment condition, such that those receiving START will improve more than those receiving ST+CTRL Changes in each mediator over time will lead to improvements in abstinence over time, and decreases in AS over time will lead to improvements in anxiety symptoms and depressed mood over time.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77204
- Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18-65 years old
- Capable of providing informed consent
- Willing to attend all study visits and comply with the protocol
- Daily smoker for at least one year
- Currently smoke an average of at least 6 cigarettes per day
- Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale
Exclusion Criteria:
- Use of other tobacco products
- Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
- Currently suicidal or high suicide risk
- Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
- Unwilling to cease use of benzodiazepines or other fast-acting anxiolytics
- Concurrent psychotherapy initiated in the past three months, or ongoing anxiety psychotherapy
- Current or intended participation in a concurrent substance abuse treatment
- Insufficient command of English to participate in assessment or treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Educational-Support Psychotherapy
Educational-based psychotherapy and standard smoking cessation treatment program
|
Other Names:
|
|
Active Comparator: Smoking Termination and Anxiety Reduction Treatment
Cognitive-behavioral treatment program that blends smoking cessation and anxiety reduction treatment strategies
|
Other Names:
Integrated smoking cessation and anxiety reduction treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short- and long-term point prevalence abstinence
Time Frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
|
The investigators will ask participants various questions about their abstinence.
The investigators will measure the length of time between when treatment ends and when/ if they start smoking again.
The unit of measure will be length of time in days.
|
Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first smoking lapse and relapse
Time Frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
|
The investigators will ask participants to record the time (in days) of their first (if any) lapse in smoking and their relapse.
|
Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
February 8, 2013
First Submitted That Met QC Criteria
February 8, 2013
First Posted (Estimate)
February 11, 2013
Study Record Updates
Last Update Posted (Actual)
April 23, 2019
Last Update Submitted That Met QC Criteria
April 19, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34DA03131301A1
- R34DA031313 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be made available upon request.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.