Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide

Predicting Treatment Response to Exposure Therapy Using a CO2 Habituation Paradigm in Patients With High Levels of Anxiety Sensitivity

Anxiety disorders affect over a quarter of the population, yet very little is known about the variables that predict treatment outcome. The planned study explores whether a patient's response to a physiological test involving inhalation of carbon dioxide predicts their response to exposure therapy.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia
• Intervention / Treatment: Behavioral: Exposure therapy

Detailed Description

Anxiety Sensitivity (AS) refers to an individual's fear of experiencing anxiety-related symptoms (e.g., dyspnea or heart palpitations) and is a core construct underlying the initiation and maintenance of pathological anxiety. Recent evidence suggests that reducing AS may be critical for the prevention and treatment of anxiety across diagnostic categories. Exposure therapy, an important component of cognitive behavioral therapy (CBT), is one of the most effective treatments for reducing AS, and has been shown to improve symptoms across a number of different anxiety disorders. Meta-analyses reveal an approximately 50% treatment response rate, with the remaining half of patients showing either no response or dropping out of treatment early. Unfortunately, there is a paucity of research exploring which variables predict treatment outcome and there are currently no tests for predicting which patients would benefit the most from exposure therapy. In this study, participants will complete two sessions of a carbon dioxide (CO2) habituation paradigm, a safe and noninvasive physiological test that entails repeated exposures to single vital capacity inhalations of 20% CO2. Both CO2 testing sessions will be completed within a 72-hour time period. Patients then complete a 10-week group-based exposure therapy to determine whether an individual's degree of habituation to CO2 predicts treatment outcome.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Laureate Institute for Brain Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. DSM-V diagnosis of an Anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia)
2. Anxiety Sensitivity Index (ASI-3) total score > 29
3. Overall Anxiety Severity and Impairment Scale (OASIS) score > 8
4. Between 18-55 years of age
5. Subject must be "treatment-seeking" and willing to enroll in the 10-week group-based Exposure Therapy

Exclusion Criteria:

1. Comorbid Bipolar Disorder, Schizophrenia, Anorexia or Bulimia Nervosa, or Obsessive-Compulsive Disorder
2. Current Substance Use Disorder > moderate (within the past 6 months)
3. Currently taking a psychotropic medication
4. Currently receiving psychotherapy/counseling for anxiety
5. Currently being treated as an inpatient
6. Active suicidal ideation with intent or plan
7. History of neurological, cardiovascular or respiratory problems (e.g., asthma, severe brain injury)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure therapy; Participants complete 10 weekly sessions of a group-based exposure therapy class for anxiety disorders.	Behavioral: Exposure therapy; 10 weekly sessions of group-based exposure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-session habituation of self-reported anxiety	Maximum anxiety rating on a 10-point rating dial (0=no anxiety to 10=most anxiety ever) during day 1 of CO2 testing minus the maximum anxiety rating during day 2 of CO2 testing	Across two days of CO2 testing within a 72-hour window

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-session habituation of self-reported dyspnea	Dyspnea rating (difficulty breathing, shortness of breath or smothering) on a 100-point visual analogue scale (0=not at all to 100=extremely) during day 1 of CO2 testing minus the dyspnea rating during day 2 of CO2 testing	Across two days of CO2 testing within a 72-hour window
Between-session reduction in avoidance behavior	Average response latency (in seconds) between vital capacity breaths of CO2 during day 1 of CO2 testing minus the average response latency during day 2 of CO2 testing	Across two days of CO2 testing within a 72-hour window

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.
• Investigators: Principal Investigator: Justin Feinstein, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Panic Disorder; Agoraphobia
• Other Study ID Numbers: CoBRE CO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No