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Completed

NCT Number: NCT01753141

Smoking Treatment and Anxiety Management Program

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioral therapy for smoking cessation

Behavioral

Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.

Behavioral

Includes anxiety sensitivity (AS) psychoeducation and interoceptive exposure exercises in addition to regular smoking cognitive behavioral therapy.

Primary outcomes

  1. Anxiety Sensitivity Index

    Time frame: 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 outcomes

  1. Smoking Status

    Time frame: week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Acronym: STAMP

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2012
Registry last updated
Sep 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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