RECRUITING

CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy

Conditions

Obsessive-Compulsive Disorder Post Traumatic Stress Disorder Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?"

Official Title

Carbon Dioxide (CO2) Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy

Quick Facts

Study Start:2022-11-02

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05467683

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* A primary DSM-5 diagnosis of panic disorder (with or without an agoraphobia diagnosis), social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder as assessed by the Structured Clinical Interview for the DSM-5 (SCID-5) * A score of 8 or greater on the Overall Anxiety Severity and Impairment Scale (OASIS) * Ages 18 to 70 * Willingness and ability to provide informed consent and comply with the requirements of the study protocol. * Proficiency in English (because assessment instruments have only been validated in English)	* A lifetime history of bipolar or psychotic disorders, substance use disorders (other than nicotine) or eating disorder in the past 6 months; serious cognitive impairment. * Active suicidal ideation with at least some intent to act with or without specific plan (a rating of 4 for suicidal ideation on the Columbia-Suicide Severity Rating Scale) or suicidal behaviors (actual attempt, interrupted attempt, aborted or self-interrupted attempt, or preparatory acts or behavior) within the past 6 months. * Medical conditions contraindicating CO2 inhalation or hyperventilation challenge (e.g., cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke). * Pregnancy or lactation * Ongoing psychotherapy directed toward the primary disorder. * Pharmacological treatment started within 8 weeks prior to the screen (patients "stable" on their medication regimen will be included and their medication status will be included as a variable in the model)

Inclusion Criteria

Exclusion Criteria

* A primary DSM-5 diagnosis of panic disorder (with or without an agoraphobia diagnosis), social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder as assessed by the Structured Clinical Interview for the DSM-5 (SCID-5)
* A score of 8 or greater on the Overall Anxiety Severity and Impairment Scale (OASIS)
* Ages 18 to 70
* Willingness and ability to provide informed consent and comply with the requirements of the study protocol.
* Proficiency in English (because assessment instruments have only been validated in English)

* A lifetime history of bipolar or psychotic disorders, substance use disorders (other than nicotine) or eating disorder in the past 6 months; serious cognitive impairment.
* Active suicidal ideation with at least some intent to act with or without specific plan (a rating of 4 for suicidal ideation on the Columbia-Suicide Severity Rating Scale) or suicidal behaviors (actual attempt, interrupted attempt, aborted or self-interrupted attempt, or preparatory acts or behavior) within the past 6 months.
* Medical conditions contraindicating CO2 inhalation or hyperventilation challenge (e.g., cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke).
* Pregnancy or lactation
* Ongoing psychotherapy directed toward the primary disorder.
* Pharmacological treatment started within 8 weeks prior to the screen (patients "stable" on their medication regimen will be included and their medication status will be included as a variable in the model)

Contacts and Locations

Principal Investigator

Jasper Smits, Ph.D.

PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Michael Otto, Ph.D.

PRINCIPAL_INVESTIGATOR

Boston University

Study Locations (Sites)

Boston University

Boston, Massachusetts, 02215

United States

The University of Texas at Austin

Austin, Texas, 78712

United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

Jasper Smits, Ph.D., PRINCIPAL_INVESTIGATOR, The University of Texas at Austin
Michael Otto, Ph.D., PRINCIPAL_INVESTIGATOR, Boston University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-02

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2022-11-02

Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

Obsessive-Compulsive Disorder
Post Traumatic Stress Disorder
Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder