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

Conditions

• Generalized Anxiety Disorder
• Obsessive-Compulsive Disorder
• Panic Disorder
• Post Traumatic Stress Disorder
• Social Anxiety Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Exposure-Based Therapy — BEHAVIORAL
  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".

Study Details

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?"

Key Dates

Start date

Nov 2, 2022

Status verified

Jun 2026

Primary completion

Dec 1, 2026

Completion

Feb 28, 2027

Study Design

Enrollment

600 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Open Exposure-Based Therapy (EBT)
  All participants will receive a well-established psychological treatment.

Primary Outcome Measure

Non-response to exposure-based therapy [ Time Frame: Week 13 (post-treatment) ]

Locations (2)

Find similar trials in Boston, MA

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