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Personalized Feedback for Distress Intolerant Smokers

Primary Purpose

Anxiety Disorders, Depression, Psychological Distress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PFI for Smoking & Distress Tolerance
PFI for Smoking Only
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 Psychological Distress, Tobacco, Smoking, Feedback, Stress, Anxiety Disorders, Depression

Eligibility Criteria

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

Inclusion Criteria:

  • Low distress tolerance defined as a DTS mean score of 2.56 or lower
  • Daily smoking for at least one year (minimum 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis at least 5 ppm)

Exclusion Criteria:

  • Currently engaging in treatment for an alcohol/drug problem including smoking cessation
  • Active Suicidality
  • Psychosis
  • Legal status that will interfere with participating
  • Not being fluent in English

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

PFI for Smoking & Distress Tolerance

PFI for Smoking Only

Arm Description

A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.

A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).

Outcomes

Primary Outcome Measures

Rulers for Smoking Cessation
The Rulers for Smoking Cessation asks participants to rate three rulers associated with motivation, confidence, and intention to quit smoking. Motivation is indexed by, "How important is stopping smoking to you (0 = Not important at all; 10 = Most important goal of my life)?" with a higher score indicating a better outcome. Confidence is indexed by, "How confident are you that you will quit smoking within the next month (0 = Not at all; 10 = 100% confident)?" with a higher score indicating a better outcome. Intention is indexed by, "How ready are you to quit smoking within the next month (0 = Not at all; 10 = 100% ready)?" with a higher score indicating a better outcome.
Barriers to Cessation Scale
The Barriers to Cessation Scale assesses 19-barriers, or specific stressors, associated with smoking cessation. Participants indicate, according to a 4-point Likert-style scale (0 = Not a barrier to 3 = Large barrier), the extent to which they identify with each of the barriers to cessation. Lower scores indicate a better outcome (range = 0 - 57).
Smoking History Questionnaire
The Smoking History Questionnaire is a self-report questionnaire used that will be used to assess smoking rate and number of quit attempts. This measure contains 30 items including open ended formats in which the individual will self-report their smoking rate per day and number of previous quit attempts. Lower reported smoking rate indicates a better outcome. Higher reported number of quit attempts indicates a better outcome.
Distress Tolerance Scale
The Distress Tolerance Scale is a self-report measure in which respondents indicate, on a 5-point Likert-type scale (1 = 'strongly agree' to 5 = 'strongly disagree'), the extent to which they believe they can experience and withstand distressing emotional states. All items are averaged to create a total mean score ranging from 1 to 5 with higher total scores indicating a better outcome.
Mood and Anxiety Symptom Questionnaire-Short Form
The Mood and Anxiety Symptom Questionnaire-Short Form will be used to assess anxiety/depressive symptoms. Participants indicate how much they have experienced each symptom on a 5-point Likert-type scale (1 = Not at all to 5 = Extremely). Specifically, the Anxious Arousal subscale will be used to measure anxiety and the Anhedonic Depression subscale will be used to measure depression. The Anxious Arousal subscale consists of 17-items with lower scores indicating better outcomes (range = 17 - 85). The Anhedonic Depression subscale consists of 22-items with lower scores indicating better outcomes (range = 22 - 110).
Self-Help Scale
The Self-Help Scale asks participants to indicate whether they would be willing to try each of 10 strategies to help deal with depression and anxiety on a 5-point Likert-type scale from 0 (definitely not) to 4 (extremely willing). Higher scores indicate a better outcome (range = 0 - 40).

Secondary Outcome Measures

Full Information

First Posted
February 15, 2019
Last Updated
October 28, 2021
Sponsor
University of Houston
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03918031
Brief Title
Personalized Feedback for Distress Intolerant Smokers
Official Title
Personalized Feedback for Distress Intolerant Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
October 24, 2021 (Actual)
Study Completion Date
October 24, 2021 (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 distress tolerance. The PFI will focus on feedback about smoking behavior, distress tolerance, 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 distress tolerance to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, increase distress tolerance, reduce anxiety/depressive symptoms, and increase adaptive coping skills compared to a personalized feedback on smoking only control. To address this aim, the investigators will implement a randomized controlled trial that will employ a longitudinal experimental design and involve four 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 (Active PFI versus Control PFI with no personalized feedback on distress tolerance), and a post-intervention assessment; (c) 2-week follow-up; (d) 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, Depression, Psychological Distress, Tobacco Dependence, Smoking, Tobacco, Smoking, Cigarette
Keywords
Psychological Distress, Tobacco, Smoking, Feedback, Stress, Anxiety Disorders, Depression

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 one-session computer-delivered intervention: either (1) personalized feedback intervention on ability to handle discomfort and smoking or (2) personalized feedback intervention on smoking only.
Masking
Participant
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PFI for Smoking & Distress Tolerance
Arm Type
Active Comparator
Arm Description
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
Arm Title
PFI for Smoking Only
Arm Type
Active Comparator
Arm Description
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Intervention Type
Behavioral
Intervention Name(s)
PFI for Smoking & Distress Tolerance
Intervention Description
Personalized Feedback Intervention for smoking and distress tolerance.
Intervention Type
Behavioral
Intervention Name(s)
PFI for Smoking Only
Intervention Description
Personalized Feedback Intervention for smoking only (no distress tolerance component)
Primary Outcome Measure Information:
Title
Rulers for Smoking Cessation
Description
The Rulers for Smoking Cessation asks participants to rate three rulers associated with motivation, confidence, and intention to quit smoking. Motivation is indexed by, "How important is stopping smoking to you (0 = Not important at all; 10 = Most important goal of my life)?" with a higher score indicating a better outcome. Confidence is indexed by, "How confident are you that you will quit smoking within the next month (0 = Not at all; 10 = 100% confident)?" with a higher score indicating a better outcome. Intention is indexed by, "How ready are you to quit smoking within the next month (0 = Not at all; 10 = 100% ready)?" with a higher score indicating a better outcome.
Time Frame
Assess change from baseline to 2-week and 1-month follow-up
Title
Barriers to Cessation Scale
Description
The Barriers to Cessation Scale assesses 19-barriers, or specific stressors, associated with smoking cessation. Participants indicate, according to a 4-point Likert-style scale (0 = Not a barrier to 3 = Large barrier), the extent to which they identify with each of the barriers to cessation. Lower scores indicate a better outcome (range = 0 - 57).
Time Frame
Assess change from baseline to 2-week and 1-month follow-up
Title
Smoking History Questionnaire
Description
The Smoking History Questionnaire is a self-report questionnaire used that will be used to assess smoking rate and number of quit attempts. This measure contains 30 items including open ended formats in which the individual will self-report their smoking rate per day and number of previous quit attempts. Lower reported smoking rate indicates a better outcome. Higher reported number of quit attempts indicates a better outcome.
Time Frame
Assess change from baseline to 2-week and 1-month follow-up
Title
Distress Tolerance Scale
Description
The Distress Tolerance Scale is a self-report measure in which respondents indicate, on a 5-point Likert-type scale (1 = 'strongly agree' to 5 = 'strongly disagree'), the extent to which they believe they can experience and withstand distressing emotional states. All items are averaged to create a total mean score ranging from 1 to 5 with higher total scores indicating a better outcome.
Time Frame
Assess change from baseline to 2-week and 1-month follow-up
Title
Mood and Anxiety Symptom Questionnaire-Short Form
Description
The Mood and Anxiety Symptom Questionnaire-Short Form will be used to assess anxiety/depressive symptoms. Participants indicate how much they have experienced each symptom on a 5-point Likert-type scale (1 = Not at all to 5 = Extremely). Specifically, the Anxious Arousal subscale will be used to measure anxiety and the Anhedonic Depression subscale will be used to measure depression. The Anxious Arousal subscale consists of 17-items with lower scores indicating better outcomes (range = 17 - 85). The Anhedonic Depression subscale consists of 22-items with lower scores indicating better outcomes (range = 22 - 110).
Time Frame
Assess change from baseline to 2-week and 1-month follow-up
Title
Self-Help Scale
Description
The Self-Help Scale asks participants to indicate whether they would be willing to try each of 10 strategies to help deal with depression and anxiety on a 5-point Likert-type scale from 0 (definitely not) to 4 (extremely willing). Higher scores indicate a better outcome (range = 0 - 40).
Time Frame
Assess change from baseline to 2-week and 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Low distress tolerance defined as a DTS mean score of 2.56 or lower Daily smoking for at least one year (minimum 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis at least 5 ppm) Exclusion Criteria: Currently engaging in treatment for an alcohol/drug problem including smoking cessation Active Suicidality Psychosis Legal status that will interfere with participating Not being fluent in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooke Kauffman, M.A.
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Zvolensky, Ph.D.
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

Plan to Share IPD
No

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Personalized Feedback for Distress Intolerant Smokers

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