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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure therapy | Experimental | Participants complete 10 weekly sessions of a group-based exposure therapy class for anxiety disorders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure therapy | Behavioral | 10 weekly sessions of group-based exposure therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Feinstein, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laureate Institute for Brain Research | Tulsa | Oklahoma | 74136 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2018 | Nov 16, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D016584 | Panic Disorder |
| D000379 | Agoraphobia |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| D007171 | Implosive Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |