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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
See: Arm/group descriptions
See: Arm/group descriptions
University of Texas at Austin
Austin, Texas, United States
RECRUITINGOverall Anxiety Severity and Impairment Scale
Change from baseline in self-reported transdiagnostic anxiety symptoms (range = 0 - 20, with higher scores indexing more symptoms).
Time frame: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Computerized Hamilton Anxiety Scale
Change from baseline in anxiety symptom severity. Each item is assessed both in terms of frequency and severity. Scores on these probes are summed and divided by the number of response options. Higher scores index higher severity.
Time frame: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Sheehan Disability Scale
Change from baseline in overall disability (range = 0 - 30, with higher scores indexing more disability).
Time frame: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
PROMIS - Global Health (Mental Health Subdomain)
Change from baseline in quality of life (range = 4 - 20, with higher scores indexing higher quality of life).
Time frame: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Anxiety Sensitivity Composite Measure
This composite measure will incorporate scores on the Anxiety Sensitivity Index-3 (ASI-3), Body Sensations Questionnaire (BSQ), and Texas Multi-Factor Anxiety Sensitivity Scale (TMASS). Scores on each of these individual measures will be transformed into z scores and then averaged to derive this composite index. We will measure change from baseline in anxiety sensitivity.
Time frame: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Modified DIAMOND
Change from baseline in DIAMOND Diagnostic Interview + Health Anxiety Questionnaire scores.
Time frame: Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13)
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