Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

NCT03382093 | Completed DMC

• 2 other identifiers: CR000002675F31DA043390-02
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anxiety Sensitivity; Tobacco; Smoking; Anxiety; Feedback; Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Smoking Motivational Processes

  Assessed at 1-month follow-up after the one-session intervention

• Smoking Behavior

  Assessed at 1-month follow-up after the one-session intervention

• Affective Processes

  Assessed at 1-month follow-up after the one-session intervention

• Mechanisms

  Assessed at 1-month follow-up after the one-session intervention

Study Arms (2)

Personalized Feedback Intervention

ACTIVE COMPARATOR

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

Smoking Information Control

ACTIVE COMPARATOR

Standard, computer-delivered smoking cessation treatment/information.

Behavioral: Smoking Information Control

Interventions

Personalized Feedback Intervention BEHAVIORAL

Personalized Feedback Intervention for smoking and anxiety.

Also known as: PFI

Personalized Feedback Intervention

Smoking Information Control BEHAVIORAL

Smoking Information with no personalized feedback.

Also known as: Control, Clearing the Air Pamphlet

Smoking Information Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Tobacco Use Disorder; Cigarette Smoking; Tobacco Smoking; Smoking

Condition Hierarchy (Ancestors)

Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Tobacco Use

Study Officials

• Lorra L. Garey, MA

  University of Houston

  PRINCIPAL INVESTIGATOR

• Michael J. Zvolensky, PHD

  University of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychology Doctoral Student

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 22, 2017
• Study Start: August 23, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

US (1)