CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy
Recruiting · NCT05467683 · Interventional (participants receive a specific treatment) · Lead sponsor: Jasper A. Smits
View the official record on ClinicalTrials.gov →Interventions studied
Exposure-Based Therapy
What this trial is about
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?"
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
2 locations listed across 2 US states.
- Boston University - Boston, Massachusetts, United States
- The University of Texas at Austin - Austin, Texas, United States