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

Anxiety Disorders Clinical Trial

Official title: Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Stress Disorder
• Adjustment Disorder With Anxious Mood
• Adjustment Disorders
• Agoraphobia
• Anxiety Disorders
• Generalized Anxiety Disorder
• Illness Anxiety Disorder
• Panic Disorder
• Phobia, Social
• Posttraumatic Stress Disorder
• Social Anxiety Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute
• Trauma

• NCT number: NCT05427708
• Study type: Interventional
• Source: University of Texas at Austin
• Contact: Michael J Telch, PhD
• Phone: 512-814-5480
• Email: telch@austin.utexas.edu
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Completion date: May 2025