Smoking Treatment and Anxiety Management Program

Study Overview
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Brief Summary
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The Smoking Treatment and Anxiety Management Program (STAMP) is a treatment program focused on helping people manage their anxiety while quitting smoking. The study involves coming in to our clinic for 4 treatment sessions, with follow-ups for up to 2 years (a week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up). Participants will be paid $142.50 for their full participation as well as receive 6 weeks of free nicotine replacement patches.

Official Title
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Smoking Treatment and Anxiety Management Program

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for smoking cessation
* Behavioral: Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anxiety Sensitivity Index greater than 15 Daily smoker for at least 1 year Less than 45 years old Currently smoke at least 8 cigarettes per day Report a motivation to quit smoking Exclusion Criteria: History of panic disorder Psychotropic medication use (if not stable for 3 months) History of significant medical condition Current use of smoking cessation pharmacology Use of other tobacco products Planning to move in the next 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Cognitive Behavioral Therapy for smoking cessation plus anxiety sensitivity reduction. | Behavioral: Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.<br>* Includes anxiety sensitivity (AS) psychoeducation and interoceptive exposure exercises in addition to regular smoking cognitive behavioral therapy.<br>|
| Active Comparator: Control<br>Cognitive Behavioral Therapy for smoking cessation. | Behavioral: Cognitive Behavioral Therapy for smoking cessation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Sensitivity Index | The ASI is a 16-item self-report measure that assesses the fear of consequences of bodily sensations associated with anxiety. Items are rated on a five-point Likert-type scale ranging from 0 (very little) to 4 (very much) and a total score is computed by summing all items. The ASI is hierarchical in structure with one higher order factor (AS) and three subfactors (physical, cognitive, and social concerns). The physical concerns subscale includes items related to the fear of consequences or presence of specific physical sensations (e.g. When I notice that my heart is beating rapidly, I worry that I might have a heart attack). The cognitive concerns subscale includes items related to potential mental health implications of sensations (e.g. When I cannot keep my mind on a task, I worry that I might be going crazy). The social concerns subscale includes items related to the potential social consequences of physical sensations (e.g. It is important to me not to appear nervous). | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Status |  | week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, Smoking Cessation