University of Texas at Austin
Austin, Texas, 78712, United States
Location status: Recruiting
Location contact
Michael J Telch, PhD
CONTACT
Michael J Telch, PhD
PRINCIPAL_INVESTIGATOR
Shristi Saraff
CONTACT
NCT Number: NCT05427708
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Austin, Texas, 78712, United States
Location status: Recruiting
Michael J Telch, PhD
CONTACT
Michael J Telch, PhD
PRINCIPAL_INVESTIGATOR
Shristi Saraff
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See: Arm/group descriptions
Other names: CGRI
See: Arm/group descriptions
Other names: PsyEd
Time frame: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
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)
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), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
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)
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)
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), 2-Month Follow-Up (Week 13)
Change from baseline in DIAMOND Diagnostic Interview + Health Anxiety Questionnaire scores.
Contact information is provided by the study sponsor or research team.
Michael J Telch, PhD
CONTACT
Shristi Saraff
CONTACT
University of Texas at Austin
Other
Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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