Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

NCT ID: NCT03382093

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2019-06-01

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.

Conditions

Anxiety Disorders; Anxiety; Tobacco Dependence; Smoking, Cigarette; Smoking, Tobacco

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Personalized Feedback Intervention

Intervention Type: BEHAVIORAL

Personalized Feedback Intervention for smoking and anxiety.

Smoking Information Control

Standard, computer-delivered smoking cessation treatment/information.

Group Type: ACTIVE_COMPARATOR

Smoking Information Control

Intervention Type: BEHAVIORAL

Smoking Information with no personalized feedback.

Interventions

Personalized Feedback Intervention

Personalized Feedback Intervention for smoking and anxiety.

Intervention Type: BEHAVIORAL

Smoking Information Control

Smoking Information with no personalized feedback.

Intervention Type: BEHAVIORAL

Other Intervention Names

PFI; Control; Clearing the Air Pamphlet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Lorra Garey

Clinical Psychology Doctoral Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorra L. Garey, MA

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Michael J. Zvolensky, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

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

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5F31DA043390-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CR00000267

Identifier Type: -

Identifier Source: org_study_id