Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety

Last updated: November 17, 2023
Sponsor: University of Texas at Austin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Social Phobia

Post-traumatic Stress Disorders

Anxiety Disorders

Treatment

Psycho-Education

Interoceptive Exposure

Capnometry-Guided Respiratory Intervention

Clinical Study ID

NCT05427708
STUDY00002306
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinically elevated anxiety as indicated by an eight or higher on the Overall AnxietySeverity and Impairment Scale (OASIS).
  2. Meets DSM-5 criteria for one or more of the following anxiety or trauma-relateddisorders as their "primary" mental disorder:
  • Generalized Anxiety Disorder
  • Panic Disorder
  • Health Anxiety
  • Agoraphobia
  • Social Anxiety Disorder
  • Posttraumatic Stress Disorder
  • Acute Stress Disorder
  • Adjustment Disorder with primary anxious mood
  • Anxiety disorder not otherwise specified
  1. No current use of psychotropic medications or stable on current medications for atleast 6 weeks
  2. Age 18+.
  3. Able to arrange transportation to our laboratory for study appointments.
  4. Fluent in English.

Exclusion

Exclusion Criteria:

  1. No history of medical conditions that would contraindicate participation infear-provocation or respiratory challenges, including:
  • Cardiovascular or respiratory disorders
  • High blood pressure
  • Epilepsy
  • Strokes
  • Seizures
  • History of fainting
  • Pregnant or lactating
  1. Not currently receiving other psychological treatment for anxiety.
  2. No history of a suicide attempt within the past 6 months.
  3. No history of psychosis within the past 6 months.
  4. No history of moderate to severe alcohol or substance use disorder (with the exceptionof nicotine) within the past 3 months.
  5. Does not endorse COVID-19 symptoms during the screening phase.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Psycho-Education
Phase:
Study Start date:
August 22, 2022
Estimated Completion Date:
May 31, 2025

Study Description

Anxiety sensitivity - the tendency to perceive anxiety as threatening - is a widely recognized risk factor for the development of panic disorder and other anxiety-related psychopathology. Interoceptive exposure therapy consisting of repeated exposure to interoceptive cues using respiratory provocation challenges such as hyperventilation and inhalation of various concentrations of CO2-enriched air have shown promise in reducing AS and are often included in cognitive-behavioral treatments of panic disorder with or without agoraphobia.However, some patients are unwilling to undergo exposure-based treatments, while others who do show only partial response or subsequent relapse.

Alternatively, low end-tidal CO2 (ETCO2), which is an accompanying feature of hyperventilation, has been associated with a variety of anxiety disorders, including panic disorder and social phobia. More recently, researchers have examined the efficacy of capnometry-guided respiratory intervention (CGRI) as a method for increasing ETCO2 and thereby reducing hyperventilation-induced anxiety/panic symptoms. Promising preliminary efficacy studies have shown that CGRI results in decreased panic symptom frequency and severity at a rate comparable to that of cognitive therapy. A recent uncontrolled proof-of-concept study showed that CGRI led to significant reductions in trauma symptoms in a sample of patients meeting DSM-5 criteria for PTSD. However, neither IE or CGRI has been adequately evaluated in the treatment of anxiety disorders other than panic disorder with or without agoraphobia.

Connect with a study center

  • University of Texas at Austin

    Austin, Texas 78712
    United States

    Active - Recruiting

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