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

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ClinicalTrials.gov Identifier: NCT04259190
Recruitment Status : Withdrawn (Halted due to COVID-19.)
First Posted : February 6, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Gina Boullion, University of Mississippi, Oxford

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.

Condition or disease Intervention/treatment Phase
Anxiety Sensitivity Behavioral: interoceptive exposure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does a Values Rationale Increase Willingness to Tolerate Distress in Interoceptive Exposure: Examination of a One-Session Randomized Clinical Trial
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Values rationale
Interoceptive exposure exercises will be introduced as a way to help participants engage in more that they value.
Behavioral: interoceptive exposure
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.

Active Comparator: Standard rationale
Interoceptive exposure exercises will be introduced as a way to help participants experience less discomfort.
Behavioral: interoceptive exposure
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 Measures :
  1. Willingness to tolerate distress [ Time Frame: change from pre-intervention to immediately post-intervention ]
    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 :
  1. Straw breathing BAT peak fear ratings [ Time Frame: pre-intervention ]
    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.

  2. Overbreathing BAT peak fear ratings [ Time Frame: immediately post-intervention ]
    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.

  3. Between trial fear ratings [ Time Frame: change from pre-intervention to immediately post-intervention ]
    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.

  4. Anxiety Sensitivity Index - 3 (ASI-3) [ Time Frame: change from pre-intervention to immediately post-intervention ]
    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.

  5. Albany Panic and Phobia Questionnaire (APPQ) [ Time Frame: change from pre-intervention to immediately post-intervention ]
    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.

  6. Between trial tolerability ratings [ Time Frame: change from pre-intervention to immediately post-intervention ]
    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.

  7. Treatment Acceptability Questionnaire [ Time Frame: immediately post-intervention ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259190


Locations
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United States, Mississippi
University of Mississippi
University, Mississippi, United States, 38677
Sponsors and Collaborators
Gina Boullion
Investigators
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Principal Investigator: Gina Boullion, M.S. University of Mississippi Medical Center
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Responsible Party: Gina Boullion, Doctoral Candidate, University of Mississippi, Oxford
ClinicalTrials.gov Identifier: NCT04259190    
Other Study ID Numbers: 20-024
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gina Boullion, University of Mississippi, Oxford:
anxiety sensitivity
panic
interoceptive exposure
exposure therapy
values
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases