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

NCT04259190 | Withdrawn

• 1 other identifier: 20-024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Sensitivity

Keywords

anxiety sensitivity; panic; interoceptive exposure; exposure therapy; values

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Straw breathing BAT peak fear ratings

  pre-intervention

• Overbreathing BAT peak fear ratings

  immediately post-intervention

• Between trial fear ratings

  change from pre-intervention to immediately post-intervention

• Anxiety Sensitivity Index - 3 (ASI-3)

  change from pre-intervention to immediately post-intervention

• Albany Panic and Phobia Questionnaire (APPQ)

  change from pre-intervention to immediately post-intervention

Study Arms (2)

Values rationale

EXPERIMENTAL

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

Behavioral: interoceptive exposure

Standard rationale

ACTIVE COMPARATOR

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

Behavioral: interoceptive exposure

Interventions

interoceptive exposure BEHAVIORAL

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.

Standard rationale; Values rationale

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gina Boullion: lead

Study Sites (1)

University of Mississippi

University, Mississippi, 38677, United States

Location

Study Officials

• Gina Boullion, M.S.

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral Candidate

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 6, 2020
• Study Start: June 1, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)