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

Anxiety Sensitivity Clinical Trial

Official title:

Does a Values Rationale Increase Willingness to Tolerate Distress in Interoceptive Exposure: Examination of a One-Session Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04259190
• Other study ID #: 20-024
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: June 2020
• Source: University of Mississippi, Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Sensitivity
• Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Mississippi	University	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Gina Boullion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	change from pre-intervention to immediately post-intervention
Secondary	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.	pre-intervention
Secondary	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.	immediately post-intervention
Secondary	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.	change from pre-intervention to immediately post-intervention
Secondary	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.	change from pre-intervention to immediately post-intervention
Secondary	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.	change from pre-intervention to immediately post-intervention
Secondary	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.	change from pre-intervention to immediately post-intervention
Secondary	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.	immediately post-intervention