Smoking Treatment and Anxiety Management Program

Not Applicable

Completed

• Conditions: Nicotine Dependence
• Interventions: Behavioral: Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.; Behavioral: Cognitive Behavioral Therapy for smoking cessation

• Registration Number: NCT01753141
• Lead Sponsor: Florida State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-20
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-25
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.	Cognitive Behavioral Therapy for smoking cessation plus anxiety sensitivity reduction.
Control	Cognitive Behavioral Therapy for smoking cessation	Cognitive Behavioral Therapy for smoking cessation.

Primary Outcome Measures

Name	Time	Method
Anxiety Sensitivity Index	up to 2 years	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").

Secondary Outcome Measures

Name	Time	Method
Smoking Status	week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up

Trial Locations

Locations (1)

Anxiety and Behavioral Health Clinic; 🇺🇸 Tallahassee, Florida, United States