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Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide

NCT ID: NCT03925987

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder Agoraphobia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Exposure therapy

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

Group Type EXPERIMENTAL

Exposure therapy

Intervention Type BEHAVIORAL

10 weekly sessions of group-based exposure therapy

Interventions

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Exposure therapy

10 weekly sessions of group-based exposure therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laureate Institute for Brain Research, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Feinstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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CoBRE CO2

Identifier Type: -

Identifier Source: org_study_id