Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925987
• Other study ID #: CoBRE CO2
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: December 2023
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Generalized Anxiety Disorder
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Exposure therapy
10 weekly sessions of group-based exposure therapy

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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