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Smoking Treatment and Anxiety Management Program (STAMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norman Schmidt, Florida State University
ClinicalTrials.gov Identifier:
NCT01753141
First received: December 17, 2012
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Nicotine Dependence
Behavioral: Cognitive Behavioral Therapy for smoking cessation
Behavioral: Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Smoking Treatment and Anxiety Management Program

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Anxiety Sensitivity Index [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up ] [ Designated as safety issue: No ]

Enrollment: 378
Study Start Date: January 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Cognitive Behavioral Therapy for smoking cessation plus anxiety sensitivity reduction.
Behavioral: Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.
Includes anxiety sensitivity (AS) psychoeducation and interoceptive exposure exercises in addition to regular smoking cognitive behavioral therapy.
Active Comparator: Control
Cognitive Behavioral Therapy for smoking cessation.
Behavioral: Cognitive Behavioral Therapy for smoking cessation

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753141

Locations
United States, Florida
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
  More Information

Publications:
Brandt, C. P., Johnson, K. A., Schmidt, N. B., & Zvolensky, M. J. Main and interactive effects of emotional dysregulation and breath-holding duration in relation to panic-relevant fear and expectancies about anxiety-related sensations among daily smokers. Journal of Anxiety Disorders (26):173-181, 2012.
Capron, D. W., Blumenthal, H., Medley, A. N., Lewis, S., Feldner, M. T., Zvolensky, M. J., & Schmidt, N. B. Anxiety sensitivity cognitive concerns predict suicidality among smokers. Journal of Affective Disorders (138): 239-246, 2012.
Leventhal, A. M., Zvolensky, M. J., & Schmidt, N. B. Smoking-related correlates of depressive symptom dimensions in treatment-seeking smokers. Nicotine & Tobacco Research (13): 668-676, 2011.

Responsible Party: Norman Schmidt, Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01753141     History of Changes
Other Study ID Numbers: R01 MH076629-01A1
Study First Received: December 17, 2012
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Florida State University:
Cognitive Behavioral Therapy
Smoking Cessation

ClinicalTrials.gov processed this record on November 20, 2014