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Completed

NCT Number: NCT03382093

Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston

Houston, Texas, 77204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Personalized Feedback Intervention

Behavioral

Personalized Feedback Intervention for smoking and anxiety.

Other names: PFI

Smoking Information Control

Behavioral

Smoking Information with no personalized feedback.

Other names: Control, Clearing the Air Pamphlet

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2017
Registry last updated
Jun 19, 2019

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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