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Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Primary Purpose

Anxiety Disorders, Anxiety, Tobacco Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Feedback Intervention
Smoking Information Control
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Anxiety Sensitivity, Tobacco, Smoking, Anxiety, Feedback, Stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Personalized Feedback Intervention

Smoking Information Control

Arm Description

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.

Standard, computer-delivered smoking cessation treatment/information.

Outcomes

Primary Outcome Measures

Evaluate PFI
Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.

Secondary Outcome Measures

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.
Smoking Behavior
Smokers in intervention, relative to a smoking information control, will report reduced smoking rates. Assessed using Carbon Monoxide [CO] analysis.
Affective Processes
Smokers in intervention, relative to a smoking information control, will report greater reductions in anxiety sensitivity. Assessed using Anxiety Sensitivity Index measure.
Mechanisms
Smokers in the intervention, relative to the smoking information control, will report decreased positive consequences for continued smoking. Assessed using Smoking Consequence Questionnaire.

Full Information

First Posted
November 27, 2017
Last Updated
June 18, 2019
Sponsor
University of Houston
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03382093
Brief Title
Personalized Feedback for Smokers With Elevated Anxiety Sensitivity
Official Title
Personalized Feedback for Smokers With Elevated Anxiety Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Anxiety, Tobacco Dependence, Smoking, Cigarette, Smoking, Tobacco
Keywords
Anxiety Sensitivity, Tobacco, Smoking, Anxiety, Feedback, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized Feedback Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Smoking Information Control
Arm Type
Active Comparator
Arm Description
Standard, computer-delivered smoking cessation treatment/information.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Feedback Intervention
Other Intervention Name(s)
PFI
Intervention Description
Personalized Feedback Intervention for smoking and anxiety.
Intervention Type
Behavioral
Intervention Name(s)
Smoking Information Control
Other Intervention Name(s)
Control, Clearing the Air Pamphlet
Intervention Description
Smoking Information with no personalized feedback.
Primary Outcome Measure Information:
Title
Evaluate PFI
Description
Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.
Time Frame
Assessed at 1-month follow-up after the one-session intervention
Secondary Outcome Measure Information:
Title
Smoking Motivational Processes
Description
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.
Time Frame
Assessed at 1-month follow-up after the one-session intervention
Title
Smoking Behavior
Description
Smokers in intervention, relative to a smoking information control, will report reduced smoking rates. Assessed using Carbon Monoxide [CO] analysis.
Time Frame
Assessed at 1-month follow-up after the one-session intervention
Title
Affective Processes
Description
Smokers in intervention, relative to a smoking information control, will report greater reductions in anxiety sensitivity. Assessed using Anxiety Sensitivity Index measure.
Time Frame
Assessed at 1-month follow-up after the one-session intervention
Title
Mechanisms
Description
Smokers in the intervention, relative to the smoking information control, will report decreased positive consequences for continued smoking. Assessed using Smoking Consequence Questionnaire.
Time Frame
Assessed at 1-month follow-up after the one-session intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorra L. Garey, MA
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Zvolensky, PHD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Links:
URL
http://uh.edu/ahrl-sutc
Description
Project Website

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Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

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