Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Sponsor

University of Houston (Other)

Overall Status

Completed

CT.gov ID

NCT03382093

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

21.3

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Anxiety Tobacco Dependence Smoking, Cigarette Smoking, Tobacco	Behavioral: Personalized Feedback Intervention Behavioral: Smoking Information Control	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

If participant meets eligibility criteria, the participant will be randomly assigned to complete a computer-delivered intervention: either the (a) Personalized Feedback Intervention or (b) smoking information control.If participant meets eligibility criteria, the participant will be randomly assigned to complete a computer-delivered intervention: either the (a) Personalized Feedback Intervention or (b) smoking information control.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Actual Study Start Date :

Aug 23, 2017

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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