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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJasper A. Smits

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Exposure-Based Therapy

Treatment groups

600 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jasper A. Smits

Lead sponsor

University of Texas at Austin

Sponsor institution

Boston University

Collaborator

National Institute of Mental Health (NIMH)

Collaborator