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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Anxiety; Tobacco Dependence; Smoking, Tobacco; Smoking, Cigarette
• Intervention / Treatment: Behavioral: Personalized Feedback Intervention; Behavioral: Smoking Information Control

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Personalized Feedback Intervention; Personalized Feedback Intervention for smoking and anxiety.; Other Names: PFI
Active Comparator: Smoking Information Control; Standard, computer-delivered smoking cessation treatment/information.	Behavioral: Smoking Information Control; Smoking Information with no personalized feedback.; Other Names: Control; Clearing the Air Pamphlet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lorra L. Garey, MA, University of Houston; Principal Investigator: Michael J. Zvolensky, PHD, University of Houston

Publications and helpful links

Helpful Links

• Project Website

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Stress; Smoking; Tobacco; Feedback; Anxiety Sensitivity
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Immune System Diseases; Hypersensitivity; Anxiety Disorders; Tobacco Use Disorder
• Other Study ID Numbers: CR00000267; 5F31DA043390-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No