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Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

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University of Houston

Status

Completed

Conditions

Tobacco Dependence
Smoking, Cigarette
Smoking, Tobacco
Anxiety
Anxiety Disorders

Treatments

Behavioral: Smoking Information Control
Behavioral: Personalized Feedback Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03382093
5F31DA043390-02 (U.S. NIH Grant/Contract)
CR00000267

Details and patient eligibility

About

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.

Full description

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.

Enrollment

95 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

95 participants in 2 patient groups

Personalized Feedback Intervention
Active Comparator group
Description:
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.
Treatment:
Behavioral: Personalized Feedback Intervention
Smoking Information Control
Active Comparator group
Description:
Standard, computer-delivered smoking cessation treatment/information.
Treatment:
Behavioral: Smoking Information Control

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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