Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety
Recruiting · NCT05427708 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas at Austin
View the official record on ClinicalTrials.gov →Interventions studied
Capnometry-Guided Respiratory InterventionPsycho-Education
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Clinically elevated anxiety as indicated by an eight or higher on the Overall Anxiety Severity and Impairment Scale (OASIS).
- 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
- No current use of psychotropic medications or stable on current medications for at least 6 weeks
- Age 18+.
- Able to arrange transportation to our laboratory for study appointments.
- Fluent in English.
Exclusion criteria
- 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
- Not currently receiving other psychological treatment for anxiety.
- No history of a suicide attempt within the past 6 months.
- No history of psychosis within the past 6 months.
- No history of moderate to severe alcohol or substance use disorder (with the exception of nicotine) within the past 3 months.
- Does not endorse COVID-19 symptoms during the screening phase.
Where it is running
1 location listed across 1 US state.
- University of Texas at Austin - Austin, Texas, United States