Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Not Applicable

Completed

• Conditions: Anxiety Disorders; Smoking, Tobacco; Anxiety; Tobacco Dependence; Smoking, Cigarette
• Interventions: Behavioral: Personalized Feedback Intervention; Behavioral: Smoking Information Control

• Registration Number: NCT03382093
• Lead Sponsor: University of Houston

Brief Summary

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.

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 Timeline

• Study Start: 2017-08-23
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Status Verified: 2019-06
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized Feedback Intervention	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.
Smoking Information Control	Smoking Information Control	Standard, computer-delivered smoking cessation treatment/information.

Primary Outcome Measures

Name	Time	Method
Evaluate PFI	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 Outcome Measures

Name	Time	Method
Smoking Motivational Processes	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.
Mechanisms	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.
Smoking Behavior	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	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.

Trial Locations

Locations (1)

Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston; 🇺🇸 Houston, Texas, United States