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

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?"

Conditions

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

Interventions

BEHAVIORAL

Exposure-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".

Sponsors & Collaborators

• Boston University

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Texas at Austin

  lead OTHER

Principal Investigators

• Jasper Smits, Ph.D. · The University of Texas at Austin

• Michael Otto, Ph.D. · Boston University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-02

Primary Completion

2026-12-01

Completion

2027-02-28

Countries

• United States

Study Locations