Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide

NCT03925987 | Completed

• 1 other identifier: CoBRE CO2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Between-session habituation of self-reported dyspnea

  Across two days of CO2 testing within a 72-hour window

• Between-session reduction in avoidance behavior

  Across two days of CO2 testing within a 72-hour window

Study Arms (1)

Exposure therapy

EXPERIMENTAL

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

Behavioral: Exposure therapy

Interventions

Exposure therapy BEHAVIORAL

10 weekly sessions of group-based exposure therapy

Exposure therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Phobia, Social; Panic Disorder; Agoraphobia

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Justin Feinstein, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 24, 2019
• Study Start: June 7, 2018
• Primary Completion: January 31, 2020
• Study Completion: July 31, 2020
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)