RecruitingNot ApplicableNCT05467683

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

Carbon Dioxide (CO2) Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy


Sponsor

University of Texas at Austin

Enrollment

600 participants

Start Date

Nov 2, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether how your body responds to changes in carbon dioxide levels can predict how well you'll respond to exposure-based therapy for anxiety disorders such as panic disorder, social anxiety, OCD, PTSD, or generalized anxiety disorder. **You may be eligible if...** - You have been diagnosed with panic disorder, social anxiety disorder, generalized anxiety disorder, OCD, or PTSD - You score 8 or higher on a standard anxiety severity scale - You are between 18 and 70 years old - You are proficient in English **You may NOT be eligible if...** - You have a history of bipolar disorder, psychosis, or a substance use disorder (other than nicotine) - You have active thoughts of suicide with intent to act - You have a medical condition that makes CO2 inhalation unsafe (heart arrhythmia, asthma, epilepsy, high blood pressure, or stroke history) - You are pregnant or breastfeeding - You are currently in therapy for your anxiety condition - You recently started a new psychiatric medication (within the past 8 weeks) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExposure-Based Therapy

Treatment will consist of 12 one-hour sessions, delivered over the course of 12 weeks. EBT will be delivered by trained and experienced license-eligible clinicians. The study clinician will develop a personalized assessment and treatment plan for each patient. Consistent with contemporary models of EBT, exposure practice aims to help patients reestablish a sense of safety around feared cues. Hence, exposure exercises are planned to ensure violation of threat expectancies. That is, exposure practice is deemed appropriate and effective if it allows the patient to learn that what they feared would happen does not happen. Practice will occur across relevant contexts both within and outside the session (i.e., homework) and clinicians will guide patients in processing practice to facilitate the consolidation of safety learning. To achieve these ends, study clinicians will use the manual "Personalized Exposure Therapy: A Person-Centered Transdiagnostic Approach".


Locations(2)

Boston University

Boston, Massachusetts, United States

The University of Texas at Austin

Austin, Texas, United States

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NCT05467683


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