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Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety

NCT05427708 · University of Texas at Austin
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Official title
Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial
About this study
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
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.
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2022-08-22
Estimated completion: 2027-05
Last updated: 2025-08-24
Interventions
Device: Capnometry-Guided Respiratory InterventionBehavioral: Psycho-Education
Primary outcomes
  • Overall Anxiety Severity and Impairment Scale (Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13))
  • Computerized Hamilton Anxiety Scale (Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13))
Sponsor
University of Texas at Austin · other
With: Freespira, Inc.
Contacts & investigators
ContactMichael J Telch, PhD · contact · telch@austin.utexas.edu · 512-814-5480
ContactShristi Saraff · contact · utinterventionstudy@gmail.com
All locations (1)
University of Texas at AustinRecruiting
Austin, Texas, United States
Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety · TrialPath