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Smoking Treatment and Anxiety Management Program (STAMP)

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for smoking cessation
Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Cognitive Behavioral Therapy, Smoking Cessation

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anxiety and Behavioral Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active

Control

Arm Description

Cognitive Behavioral Therapy for smoking cessation plus anxiety sensitivity reduction.

Cognitive Behavioral Therapy for smoking cessation.

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

Smoking Status

Full Information

First Posted
December 17, 2012
Last Updated
September 25, 2013
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT01753141
Brief Title
Smoking Treatment and Anxiety Management Program
Acronym
STAMP
Official Title
Smoking Treatment and Anxiety Management Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Cognitive Behavioral Therapy, Smoking Cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
378 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy for smoking cessation plus anxiety sensitivity reduction.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy for smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for smoking cessation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.
Intervention Description
Includes anxiety sensitivity (AS) psychoeducation and interoceptive exposure exercises in addition to regular smoking cognitive behavioral therapy.
Primary Outcome Measure Information:
Title
Anxiety Sensitivity Index
Description
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").
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Smoking Status
Time Frame
week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Anxiety and Behavioral Health Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22119451
Citation
Brandt CP, Johnson KA, Schmidt NB, Zvolensky MJ. Main and interactive effects of emotion dysregulation and breath-holding duration in relation to panic-relevant fear and expectancies about anxiety-related sensations among adult daily smokers. J Anxiety Disord. 2012 Jan;26(1):173-81. doi: 10.1016/j.janxdis.2011.10.007. Epub 2011 Nov 6.
Results Reference
result
PubMed Identifier
22766487
Citation
Buckner JD, Zvolensky MJ, Schmidt NB. Cannabis-related impairment and social anxiety: the roles of gender and cannabis use motives. Addict Behav. 2012 Nov;37(11):1294-7. doi: 10.1016/j.addbeh.2012.06.013. Epub 2012 Jun 22.
Results Reference
result
PubMed Identifier
22154236
Citation
Buckner JD, Joiner TE Jr, Schmidt NB, Zvolensky MJ. Daily marijuana use and suicidality: the unique impact of social anxiety. Addict Behav. 2012 Apr;37(4):387-92. doi: 10.1016/j.addbeh.2011.11.019. Epub 2011 Nov 25.
Results Reference
result
PubMed Identifier
22370063
Citation
Capron DW, Blumenthal H, Medley AN, Lewis S, Feldner MT, Zvolensky MJ, Schmidt NB. Anxiety sensitivity cognitive concerns predict suicidality among smokers. J Affect Disord. 2012 May;138(3):239-46. doi: 10.1016/j.jad.2012.01.048. Epub 2012 Feb 26.
Results Reference
result
PubMed Identifier
22540436
Citation
Johnson KA, Farris SG, Schmidt NB, Zvolensky MJ. Anxiety sensitivity and cognitive-based smoking processes: testing the mediating role of emotion dysregulation among treatment-seeking daily smokers. J Addict Dis. 2012;31(2):143-57. doi: 10.1080/10550887.2012.665695.
Results Reference
result
PubMed Identifier
22209026
Citation
Peasley-Miklus CE, McLeish AC, Schmidt NB, Zvolensky MJ. An examination of smoking outcome expectancies, smoking motives and trait worry in a sample of treatment-seeking smokers. Addict Behav. 2012 Apr;37(4):407-13. doi: 10.1016/j.addbeh.2011.11.037. Epub 2011 Dec 3.
Results Reference
result
Citation
Funk, A. P., Zvolensky, M. J., & Schmidt, N. B. Homework compliance in a brief cognitive-behavioral and pharmacological intervention for smoking. Journal of Smoking Cessation (6): 99-111, 2011.
Results Reference
result
PubMed Identifier
21471305
Citation
Leventhal AM, Zvolensky MJ, Schmidt NB. Smoking-related correlates of depressive symptom dimensions in treatment-seeking smokers. Nicotine Tob Res. 2011 Aug;13(8):668-76. doi: 10.1093/ntr/ntr056. Epub 2011 Apr 6.
Results Reference
result
PubMed Identifier
30384961
Citation
Rogers AH, Bakhshaie J, Garey L, Piasecki TM, Gallagher MW, Schmidt NB, Zvolensky MJ. Individual differences in emotion dysregulation and trajectory of withdrawal symptoms during a quit attempt among treatment-seeking smokers. Behav Res Ther. 2019 Apr;115:4-11. doi: 10.1016/j.brat.2018.10.007. Epub 2018 Oct 19.
Results Reference
derived
PubMed Identifier
29683703
Citation
Zvolensky MJ, Garey L, Allan NP, Farris SG, Raines AM, Smits JAJ, Kauffman BY, Manning K, Schmidt NB. Effects of anxiety sensitivity reduction on smoking abstinence: An analysis from a panic prevention program. J Consult Clin Psychol. 2018 May;86(5):474-485. doi: 10.1037/ccp0000288.
Results Reference
derived

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Smoking Treatment and Anxiety Management Program

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