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NCT05427708NARecruiting

Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety

University of Texas at Austin

Start Date

8/22/2022

Completion Date

5/1/2027

Summary

Purpose of the Research: The primary aim of the proposed study is to conduct a randomized parallel-group 2-arm clinical trial investigating capnometry-guided respiratory intervention (CGRI) for pathological anxiety. CGRI aims to raise end-tidal CO2 levels thereby lowering hyperventilation-induced respiratory alkalosis and its associated fear-eliciting somatic reactions. Psycho-education about anxiety and its effects (PsyEd) will serve as a credible control comparator.

Detailed Description

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, CGRI has not been adequately evaluated in the treatment of anxiety disorders other than panic disorder with or without agoraphobia.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Clinically elevated anxiety as indicated by an eight or higher on the Overall Anxiety Severity and Impairment Scale (OASIS). 2. Meets DSM-5 criteria for one or more of the following anxiety or trauma-related disorders 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 3. No current use of psychotropic medications or stable on current medications for at least 6 weeks 4. Age 18+. 5. Able to arrange transportation to our laboratory for study appointments. 6. Fluent in English. Exclusion Criteria: 1. No history of medical conditions that would contraindicate participation in fear-provocation or respiratory challenges, including: * Cardiovascular or respiratory disorders * High blood pressure * Epilepsy * Strokes * Seizures * History of fainting * Pregnant or lactating 2. Not currently receiving other psychological treatment for anxiety. 3. No history of a suicide attempt within the past 6 months. 4. No history of psychosis within the past 6 months. 5. No history of moderate to severe alcohol or substance use disorder (with the exception of nicotine) within the past 3 months. 6. Does not endorse COVID-19 symptoms during the screening phase.

Interventions

DEVICE

Capnometry-Guided Respiratory Intervention

BEHAVIORAL

Psycho-Education

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Conditions

Anxiety DisordersTraumaGeneralized Anxiety DisorderPanic DisorderAgoraphobiaIllness Anxiety DisorderSocial Anxiety DisorderPosttraumatic Stress DisorderAcute Stress DisorderAdjustment Disorder With Anxious Mood

Locations

University of Texas at Austin

Austin, Texas 78712

United States