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

Launched by UNIVERSITY OF TEXAS AT AUSTIN · Jul 19, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help doctors decide if exposure-based therapy, a treatment for various anxiety and stress-related disorders, will be effective for patients. The study will use a simple test involving a CO2 challenge, which means participants will breathe in a small amount of carbon dioxide to see how their body reacts. This reaction could help predict whether someone will benefit from therapy for conditions like panic disorder, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or generalized anxiety disorder.

To join this study, participants need to be between 18 and 70 years old and have a specific anxiety or trauma-related disorder diagnosed by a professional. They should also have a certain level of anxiety, as measured by a questionnaire. However, individuals with a history of more severe mental health issues, such as bipolar disorder, or those who are pregnant, breastfeeding, or currently in therapy for their condition, are not eligible. Participants can expect to undergo the CO2 challenge along with other assessments to help researchers understand how this new test might improve treatment decisions in the future.

Gender

ALL

Eligibility criteria

• 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)