Interoceptive Exposure for Anxiety Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Texas at Austin, Austin, TX
Anxiety Disorders+15 More
Interoceptive Exposure - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Purpose of the Research: The primary aim of the proposed study is to conduct a randomized parallel-group 3-arm clinical trial comparing two mechanistically distinct interventions for pathological anxiety - (1) Interoceptive Exposure (IE) utilizing graduated exposure to somatic cues (respiratory, cardiac, vestibular) with the primary aim of reducing fear responding to the presence of interoceptive perturbations; (2) Capnometry-Guided Respiratory Intervention (CGRI) aimed at raising end-tidal CO2 levels thereby lowering hyperventilation-induced respiratory alkalosis and its associated fear-eliciting somatic reactions; and (3) Psycho-education about anxiety and its effects (PsyEd), which will serve as a credible control comparator.

Eligible Conditions

  • Anxiety Disorders
  • Agoraphobia
  • Post Traumatic Stress Disorder (PTSD)
  • Panic Attacks
  • Phobia, Social
  • Traumas
  • Stress Disorder, Acute
  • Adjustment Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)

Week 13
Modified DIAMOND
Week 13
Computerized Hamilton Anxiety Scale
Overall Anxiety Severity and Impairment Scale
Week 13
Anxiety Sensitivity Composite Measure
PROMIS - Global Health (Mental Health Subdomain)
Sheehan Disability Scale

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Psycho-Education (PsyEd)
1 of 3
Capnometry-Guided Respiratory Intervention (CGRI)
1 of 3
Interoceptive Exposure (IE)
1 of 3
Active Control
Experimental Treatment

102 Total Participants · 3 Treatment Groups

Primary Treatment: Interoceptive Exposure · No Placebo Group · N/A

Capnometry-Guided Respiratory Intervention (CGRI)
Device
Experimental Group · 1 Intervention: Capnometry-Guided Respiratory Intervention · Intervention Types: Device
Interoceptive Exposure (IE)
Behavioral
Experimental Group · 1 Intervention: Interoceptive Exposure · Intervention Types: Behavioral
Psycho-Education (PsyEd)
Behavioral
ActiveComparator Group · 1 Intervention: Psycho-Education · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-treatment (week 0), weekly assessments (weeks 1 - 4), post-treatment (week 5), 2-month follow-up (week 13)
Closest Location: University of Texas at Austin · Austin, TX
Photo of Austin 1Photo of Austin 2Photo of Austin 3
2007First Recorded Clinical Trial
7 TrialsResearching Anxiety Disorders
52 CompletedClinical Trials

Who is running the clinical trial?

Freespira, Inc.UNKNOWN
University of Texas at AustinLead Sponsor
283 Previous Clinical Trials
67,139 Total Patients Enrolled
17 Trials studying Anxiety Disorders
2,686 Patients Enrolled for Anxiety Disorders

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are not currently taking any psychotropic medications or have been on them for at least 3 months.
You have clinically elevated anxiety as indicated by an eight or higher on the OASIS.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References