Trials / Recruiting
RecruitingNCT05427708
Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety
Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- University of Texas at Austin · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Anxiety Disorders
- Trauma
- Generalized Anxiety Disorder
- Panic Disorder
- Agoraphobia
- Illness Anxiety Disorder
- Social Anxiety Disorder
- Posttraumatic Stress Disorder
- Acute Stress Disorder
- Adjustment Disorder With Anxious Mood
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Capnometry-Guided Respiratory Intervention | See: Arm/group descriptions |
| BEHAVIORAL | Psycho-Education | See: Arm/group descriptions |
Timeline
- Start date
- 2022-08-22
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2022-06-22
- Last updated
- 2025-08-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05427708. Inclusion in this directory is not an endorsement.