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A Comparison of Treatment Rationales on Willingness to Tolerate Distress in Interoceptive Exposure

Primary Purpose

Anxiety Sensitivity

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
interoceptive exposure
Sponsored by
Gina Boullion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Sensitivity focused on measuring anxiety sensitivity, panic, interoceptive exposure, exposure therapy, values

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Score ≥ 23 on the Anxiety Sensitivity Index - 3 (ASI-3)

Exclusion Criteria:

  • Seizures
  • Hypertension
  • Heart problems
  • Current pregnancy
  • Asthma
  • Other health conditions exacerbated by intense exercise

Sites / Locations

  • University of Mississippi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Values rationale

Standard rationale

Arm Description

Interoceptive exposure exercises will be introduced as a way to help participants engage in more that they value.

Interoceptive exposure exercises will be introduced as a way to help participants experience less discomfort.

Outcomes

Primary Outcome Measures

Willingness to tolerate distress
Willingness to tolerate distress will be assessed by identifying the activity item on the Albany Panic and Phobia Questionnaire (APPQ) - Agoraphobia subscale to which the participant responded with the highest score indicating most fear. The participant will then be asked, "How willing would you be to do [most feared activity] next week?" Responses will range from 0% to 100%.

Secondary Outcome Measures

Straw breathing BAT peak fear ratings
Participants will be asked to engage in hyperventilation via breathing through a cocktail straw for three consecutive minutes pre-intervention. Participants will be asked to rate their peak fear ranging from 0 ("no fear") to 100 ("extreme fear or panic") on a 100-point visual analog scale after each minute. A peak fear rating will be calculated by computing the average of the three ratings.
Overbreathing BAT peak fear ratings
Participants will be asked to engage in one last overbreathing task post-intervention to see how long they can overbreathe. After discontinuation, participants will be asked to report their current level of fear ranging from 0 ("no fear") to 100 ("extreme fear or panic") on a 100-point visual analog scale.
Between trial fear ratings
After each voluntary hyperventilation trial, participants will be asked to provide ratings of their peak fear. Participants will be asked to rate their peak fear during the trial ranging from 0 ("no fear") to 100 ("extreme fear or panic") on a 100-point visual analog scale.
Anxiety Sensitivity Index - 3 (ASI-3)
The ASI-3 is an 18-item self-report measure of the fear of physiological arousal-related sensations. Scores on the ASI-3 can range from 0 to 72, with higher scores reflecting greater fear of arousal-related symptoms.
Albany Panic and Phobia Questionnaire (APPQ)
The APPQ is a 27-item self-report measure of the fear of activities often avoided by individuals with agoraphobia and social phobia, and activities that typically produce physical sensations. Scores on the APPQ can range from 0 to 216, with higher scores reflecting higher levels of fear.
Between trial tolerability ratings
After each voluntary hyperventilation trial, participants will be asked to provide ratings of tolerability of physiological sensations. Participants will be asked to rate the extent they perceived themselves as able to tolerate the physiological sensations during hyperventilation from 0 ("unable to tolerate them at all") to 100 ("completely able to tolerate them") on a 100-point visual analog scale.
Treatment Acceptability Questionnaire
A three-item self-report questionnaire was administered to participants to assess acceptability of the treatment provided. Participants will rate treatment acceptability, likeability, and aversiveness from "not at all" to "extremely" on a five-point Likert scale. Scores on the Treatment Acceptability Questionnaire can range from 0 to 12, with higher scores reflecting greater acceptability.

Full Information

First Posted
January 31, 2020
Last Updated
June 24, 2020
Sponsor
Gina Boullion
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1. Study Identification

Unique Protocol Identification Number
NCT04259190
Brief Title
A Comparison of Treatment Rationales on Willingness to Tolerate Distress in Interoceptive Exposure
Official Title
Does a Values Rationale Increase Willingness to Tolerate Distress in Interoceptive Exposure: Examination of a One-Session Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Halted due to COVID-19.
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gina Boullion

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention for the reduction of anxiety sensitivity. A standard treatment rationale without values emphasis will serve as a control.
Detailed Description
Cognitive behavioral models of panic disorder maintain that recurrent, unexpected panic attacks result from anxiety sensitivity, or the fear of anxiety-related physiological sensations (e.g., fear of increased heart rate) and catastrophic misinterpretations regarding the danger of those sensations (e.g., misinterpreting increased heart rate as an oncoming heart attack). From these models and subsequent clinical research, interoceptive exposure has emerged as the most efficacious component of cognitive behavioral therapy for panic disorder treatment and, as expected, an efficacious intervention for decreasing anxiety sensitivity. Nevertheless, small-to-moderate effect sizes, wide variability in response rates and dropout rates indicated that panic disorder treatments may benefit from modifications to improve upon retention, response rates, and symptom reduction. Patient motivation and lack of engagement have been identified as factors to intervene upon. Numerous therapeutic techniques have been used to facilitate patient motivation in treatment; however, one specific direction that has gained increasing empirical interest is the inclusion of values identification. Values have been incorporated as a motivational component in empirically supported behavioral techniques and treatments, including Motivational Interviewing, Behavioral Activation Treatment for Depression packages, and Acceptance and Commitment Therapy. Evidence from randomized controlled trials have generally supported the inclusion of packages containing values components in facilitating exposure therapy, and preliminary evidence has specifically favored the inclusion of packages containing values components in exposure therapy in cognitive behavioral therapy for panic disorder. However, there is no research known by the author that examines the influence of values on motivation in interoceptive exposure. Therefore, research examining the effect of a values component in isolation motivation in and acceptability of interoceptive exposure exercises has the potential to further improve treatment efficacy reducing costs associated with panic disorder and the many other conditions treated by interoceptive exposure. Therefore, the purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention among a clinical analogue sample with elevated anxiety sensitivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Sensitivity
Keywords
anxiety sensitivity, panic, interoceptive exposure, exposure therapy, values

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Values rationale
Arm Type
Experimental
Arm Description
Interoceptive exposure exercises will be introduced as a way to help participants engage in more that they value.
Arm Title
Standard rationale
Arm Type
Active Comparator
Arm Description
Interoceptive exposure exercises will be introduced as a way to help participants experience less discomfort.
Intervention Type
Behavioral
Intervention Name(s)
interoceptive exposure
Intervention Description
Repeated 60-second trials of voluntary hyperventilation, each followed by a 15-second rest period. Participants will complete a minimum of 8 trials and continue additional trials until ratings of their most feared predicted outcome fall less than or below 5% likelihood.
Primary Outcome Measure Information:
Title
Willingness to tolerate distress
Description
Willingness to tolerate distress will be assessed by identifying the activity item on the Albany Panic and Phobia Questionnaire (APPQ) - Agoraphobia subscale to which the participant responded with the highest score indicating most fear. The participant will then be asked, "How willing would you be to do [most feared activity] next week?" Responses will range from 0% to 100%.
Time Frame
change from pre-intervention to immediately post-intervention
Secondary Outcome Measure Information:
Title
Straw breathing BAT peak fear ratings
Description
Participants will be asked to engage in hyperventilation via breathing through a cocktail straw for three consecutive minutes pre-intervention. Participants will be asked to rate their peak fear ranging from 0 ("no fear") to 100 ("extreme fear or panic") on a 100-point visual analog scale after each minute. A peak fear rating will be calculated by computing the average of the three ratings.
Time Frame
pre-intervention
Title
Overbreathing BAT peak fear ratings
Description
Participants will be asked to engage in one last overbreathing task post-intervention to see how long they can overbreathe. After discontinuation, participants will be asked to report their current level of fear ranging from 0 ("no fear") to 100 ("extreme fear or panic") on a 100-point visual analog scale.
Time Frame
immediately post-intervention
Title
Between trial fear ratings
Description
After each voluntary hyperventilation trial, participants will be asked to provide ratings of their peak fear. Participants will be asked to rate their peak fear during the trial ranging from 0 ("no fear") to 100 ("extreme fear or panic") on a 100-point visual analog scale.
Time Frame
change from pre-intervention to immediately post-intervention
Title
Anxiety Sensitivity Index - 3 (ASI-3)
Description
The ASI-3 is an 18-item self-report measure of the fear of physiological arousal-related sensations. Scores on the ASI-3 can range from 0 to 72, with higher scores reflecting greater fear of arousal-related symptoms.
Time Frame
change from pre-intervention to immediately post-intervention
Title
Albany Panic and Phobia Questionnaire (APPQ)
Description
The APPQ is a 27-item self-report measure of the fear of activities often avoided by individuals with agoraphobia and social phobia, and activities that typically produce physical sensations. Scores on the APPQ can range from 0 to 216, with higher scores reflecting higher levels of fear.
Time Frame
change from pre-intervention to immediately post-intervention
Title
Between trial tolerability ratings
Description
After each voluntary hyperventilation trial, participants will be asked to provide ratings of tolerability of physiological sensations. Participants will be asked to rate the extent they perceived themselves as able to tolerate the physiological sensations during hyperventilation from 0 ("unable to tolerate them at all") to 100 ("completely able to tolerate them") on a 100-point visual analog scale.
Time Frame
change from pre-intervention to immediately post-intervention
Title
Treatment Acceptability Questionnaire
Description
A three-item self-report questionnaire was administered to participants to assess acceptability of the treatment provided. Participants will rate treatment acceptability, likeability, and aversiveness from "not at all" to "extremely" on a five-point Likert scale. Scores on the Treatment Acceptability Questionnaire can range from 0 to 12, with higher scores reflecting greater acceptability.
Time Frame
immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Score ≥ 23 on the Anxiety Sensitivity Index - 3 (ASI-3) Exclusion Criteria: Seizures Hypertension Heart problems Current pregnancy Asthma Other health conditions exacerbated by intense exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina Boullion, M.S.
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi
City
University
State/Province
Mississippi
ZIP/Postal Code
38677
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Comparison of Treatment Rationales on Willingness to Tolerate Distress in Interoceptive Exposure

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