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CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy

RECRUITINGN/ASponsored by University of Texas at Austin
Actively Recruiting
PhaseN/A
SponsorUniversity of Texas at Austin
Started2022-11-02
Est. completion2026-12-01
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
Locations2 sites

Summary

Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?"

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
Inclusion Criteria:

* A primary DSM-5 diagnosis of panic disorder (with or without an agoraphobia diagnosis), social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder as assessed by the Structured Clinical Interview for the DSM-5 (SCID-5)
* A score of 8 or greater on the Overall Anxiety Severity and Impairment Scale (OASIS)
* Ages 18 to 70
* Willingness and ability to provide informed consent and comply with the requirements of the study protocol.
* Proficiency in English (because assessment instruments have only been validated in English)

Exclusion Criteria:

* A lifetime history of bipolar or psychotic disorders, substance use disorders (other than nicotine) or eating disorder in the past 6 months; serious cognitive impairment.
* Active suicidal ideation with at least some intent to act with or without specific plan (a rating of 4 for suicidal ideation on the Columbia-Suicide Severity Rating Scale) or suicidal behaviors (actual attempt, interrupted attempt, aborted or self-interrupted attempt, or preparatory acts or behavior) within the past 6 months.
* Medical conditions contraindicating CO2 inhalation or hyperventilation challenge (e.g., cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke).
* Pregnancy or lactation
* Ongoing psychotherapy directed toward the primary disorder.
* Pharmacological treatment started within 8 weeks prior to the screen (patients "stable" on their medication regimen will be included and their medication status will be included as a variable in the model)

Conditions6

AnxietyGeneralized Anxiety DisorderObsessive-compulsive DisorderPanic DisorderPost Traumatic Stress DisorderSocial Anxiety Disorder

Locations2 sites

Massachusetts

1 site
Boston University
Boston, Massachusetts, 02215
Michael Otto, Ph.D.617-353-9610mwotto@bu.edu

Texas

1 site
The University of Texas at Austin
Austin, Texas, 78712
Jasper Smits, Ph.D.512-475-8095smits@utexas.edu

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