Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Study Overview
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Brief Summary
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This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will focus on feedback about smoking behavior, AS, and adaptive coping strategies.

Detailed Description
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The primary goal of the research study is to investigate the efficacy of a brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills compared to a smoking information only control. To address this aim, we will implement a randomized controlled trial that will employ a longitudinal experimental design and involve three stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility), random assignment to a one-session computer-delivered intervention (PFI versus smoking information control with no personalized feedback), and a post-intervention assessment; (c) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.

Official Title
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Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Conditions
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Anxiety Disorders, Anxiety, Tobacco Dependence, Smoking, Cigarette, Smoking, Tobacco

Intervention / Treatment
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* Behavioral: Personalized Feedback Intervention
* Behavioral: Smoking Information Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elevated anxiety sensitivity defined as an ASI-III score of at least 17 Daily smoking for at least one year (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis at least 4 ppm) Not presently engaged in a quit attempt Not currently engaged in mental health treatment Capable of providing informed consent Willing to attend all study visits and comply with the protocol Exclusion Criteria: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners Students for whom you have direct access to/influence on grades Use of other tobacco products Currently suicidal or high suicide risk Currently psychotic or high psychotic risk Insufficient command of English to participate in assessment or treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: If participant meets eligibility criteria, the participant will be randomly assigned to complete a computer-delivered intervention: either the (a) Personalized Feedback Intervention or (b) smoking information control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Personalized Feedback Intervention<br>A brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills. | Behavioral: Personalized Feedback Intervention<br>* Personalized Feedback Intervention for smoking and anxiety.<br>* Other names: PFI;|
| Active Comparator: Smoking Information Control<br>Standard, computer-delivered smoking cessation treatment/information. | Behavioral: Smoking Information Control<br>* Smoking Information with no personalized feedback.<br>* Other names: Clearing the Air Pamphlet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate PFI | Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey. | Assessed at 1-month follow-up after the one-session intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Motivational Processes | Smokers in intervention, relative to a smoking information control, will report increased motivation and confidence for quitting smoking. Assessed using Smoking Rulers for Change measure. | Assessed at 1-month follow-up after the one-session intervention | 
| Smoking Behavior | Smokers in intervention, relative to a smoking information control, will report reduced smoking rates. Assessed using Carbon Monoxide [CO] analysis. | Assessed at 1-month follow-up after the one-session intervention | 
| Affective Processes | Smokers in intervention, relative to a smoking information control, will report greater reductions in anxiety sensitivity. Assessed using Anxiety Sensitivity Index measure. | Assessed at 1-month follow-up after the one-session intervention | 
| Mechanisms | Smokers in the intervention, relative to the smoking information control, will report decreased positive consequences for continued smoking. Assessed using Smoking Consequence Questionnaire. | Assessed at 1-month follow-up after the one-session intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety Sensitivity, Tobacco, Smoking, Anxiety, Feedback, Stress