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Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide

Primary Purpose

Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure therapy
Sponsored by
Laureate Institute for Brain Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exposure therapy

Arm Description

Participants complete 10 weekly sessions of a group-based exposure therapy class for anxiety disorders.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
April 22, 2019
Last Updated
September 18, 2020
Sponsor
Laureate Institute for Brain Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03925987
Brief Title
Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide
Official Title
Predicting Treatment Response to Exposure Therapy Using a CO2 Habituation Paradigm in Patients With High Levels of Anxiety Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laureate Institute for Brain Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure therapy
Arm Type
Experimental
Arm Description
Participants complete 10 weekly sessions of a group-based exposure therapy class for anxiety disorders.
Intervention Type
Behavioral
Intervention Name(s)
Exposure therapy
Intervention Description
10 weekly sessions of group-based exposure therapy
Primary Outcome Measure Information:
Title
Between-session habituation of self-reported anxiety
Description
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
Time Frame
Across two days of CO2 testing within a 72-hour window
Secondary Outcome Measure Information:
Title
Between-session habituation of self-reported dyspnea
Description
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
Time Frame
Across two days of CO2 testing within a 72-hour window
Title
Between-session reduction in avoidance behavior
Description
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
Time Frame
Across two days of CO2 testing within a 72-hour window

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: DSM-V diagnosis of an Anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia) Anxiety Sensitivity Index (ASI-3) total score > 29 Overall Anxiety Severity and Impairment Scale (OASIS) score > 8 Between 18-55 years of age Subject must be "treatment-seeking" and willing to enroll in the 10-week group-based Exposure Therapy Exclusion Criteria: Comorbid Bipolar Disorder, Schizophrenia, Anorexia or Bulimia Nervosa, or Obsessive-Compulsive Disorder Current Substance Use Disorder > moderate (within the past 6 months) Currently taking a psychotropic medication Currently receiving psychotherapy/counseling for anxiety Currently being treated as an inpatient Active suicidal ideation with intent or plan History of neurological, cardiovascular or respiratory problems (e.g., asthma, severe brain injury)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Feinstein, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide

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