Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 1, 2019

Detailed 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.

Interventions

  • Behavioral: Personalized Feedback Intervention
    • Personalized Feedback Intervention for smoking and anxiety.
  • Behavioral: Smoking Information Control
    • Smoking Information with no personalized feedback.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate PFI
    • Time Frame: Assessed at 1-month follow-up after the one-session intervention
    • Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.

Secondary Measures

  • Smoking Motivational Processes
    • Time Frame: Assessed at 1-month follow-up after the one-session intervention
    • Smokers in intervention, relative to a smoking information control, will report increased motivation and confidence for quitting smoking. Assessed using Smoking Rulers for Change measure.
  • Smoking Behavior
    • Time Frame: Assessed at 1-month follow-up after the one-session intervention
    • Smokers in intervention, relative to a smoking information control, will report reduced smoking rates. Assessed using Carbon Monoxide [CO] analysis.
  • Affective Processes
    • Time Frame: Assessed at 1-month follow-up after the one-session intervention
    • Smokers in intervention, relative to a smoking information control, will report greater reductions in anxiety sensitivity. Assessed using Anxiety Sensitivity Index measure.
  • Mechanisms
    • Time Frame: Assessed at 1-month follow-up after the one-session intervention
    • Smokers in the intervention, relative to the smoking information control, will report decreased positive consequences for continued smoking. Assessed using Smoking Consequence Questionnaire.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Houston
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lorra Garey, Clinical Psychology Doctoral Student – University of Houston
  • Overall Official(s)
    • Lorra L. Garey, MA, Principal Investigator, University of Houston
    • Michael J. Zvolensky, PHD, Principal Investigator, University of Houston

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