An interventional study of Exposure therapy in Generalized Anxiety Disorder, Social Anxiety Disorder and Panic Disorder, sponsored by Laureate Institute for Brain Research, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by Laureate Institute for Brain Research, Inc. · Not applicable, Interventional, and Basic science
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.
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.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's enrollment of 70 is below the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Laureate Institute for Brain Research, Inc. is the lead sponsor of 54 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants complete 10 weekly sessions of a group-based exposure therapy class for anxiety disorders.
Behavioral: Exposure therapy
10 weekly sessions of group-based exposure therapy
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
Time frame: Across two days of CO2 testing within a 72-hour window
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
Time frame: Across two days of CO2 testing within a 72-hour window
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
Time frame: Across two days of CO2 testing within a 72-hour window
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →
Laureate Institute for Brain Research, Inc.