- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01201304
Comparison of Methods for the Delivery of Interoceptive Exposure
Study Overview
Status
Conditions
Detailed Description
Cognitive-behavioral theories posit that panic attacks and panic disorder are the product of inaccurate beliefs about the dangerousness of arousal-related body sensations such as heart palpitations, dizziness, and shortness of breath. Individuals with panic disorder often misinterpret these anxiety symptoms as likely to lead to health catastrophes such as a heart attack, stroke, suffocation, or insanity. Effective psychological treatment aims to correct such misinterpretations by helping individuals learn that their anxiety-related body sensations are not dangerous.
One treatment procedure used to accomplish this goal is "interoceptive exposure," or the deliberate evocation of anxiety-related body sensations via exercises such as hyperventilation, spinning in a swivel chair, or running in place. By demonstrating that the experience of anxiety-related body sensations does not lead to physical catastrophes, interoceptive exposure exercises help individuals learn not to fear their own anxiety symptoms. Indeed, this procedure is considered an essential ingredient in evidence-based psychological treatment of panic disorder.
Despite the established therapeutic value of interoceptive exposure, little is known about how to optimally deliver this procedure. In the most clinically tested panic disorder treatment package, individuals engage in three, minute-long trials of interoceptive exposure exercises such as hyperventilation, with each trial followed by the use of diaphragmatic breathing and a rest period until all anxiety-related body sensations have subsided. However, there are theoretical reasons to question the effectiveness of this method. For example, encouraging individuals to use controlled breathing to "manage" their sensations appears incompatible with the notion that anxiety-related body sensations are harmless. Similarly, the instruction to wait until one's body sensations have subsided to begin the next interoceptive exposure trial suggests that intense body sensations are to be avoided. For these reasons, many practitioners conduct interoceptive exposure in a more intensive manner in which individuals experience feared body sensations in a prolonged fashion, without attempting to suppress or avoid them, until they learn that the sensations are harmless. Despite the theoretical appeal of this latter approach, no studies have examined the effects of delivering interoceptive exposure in this manner. Indeed, very little is known about the effects of different methods of delivering interoceptive exposure on fear of arousal-related body sensations. Accordingly, the present study aims to test the effectiveness of different methods of delivering interoceptive exposure with the goal of generating recommendations for the optimal treatment of panic disorder and other clinical problems associated with the fear of anxiety-related body sensations.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Wyoming
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Laramie, Wyoming, United States, 82071
- University of Wyoming
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Score > 21 on Anxiety Sensitivity Index - Revised Fear of Respiratory Symptoms Subscale.
Exclusion Criteria:
- Seizures
- Hypertension
- Heart problems
- Pregnancy
- Asthma
- Other health conditions exacerbated by intense exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interoceptive exposure
Repeated trials of voluntary hyperventilation intended to reduce fears of arousal-related body sensations.
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Three 60-second trials of hyperventilation, each followed by diaphragmatic breathing, cognitive reappraisal, and prolonged rest until body sensations have subsided.
Three 60-second trials of hyperventilation, each followed by a 15-second rest period and cognitive reappraisal.
Minimum of eight 60-second hyperventilation trials, each followed by 15-second rest period and cognitive reappraisal.
Trials continue until participants rate the probability that their most feared outcome will occur as less than 5% on a 0% to 100% scale.
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Placebo Comparator: Expressive writing
Expectancy control intervention.
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Individuals randomized to the expressive writing control group will receive a rationale for why writing about emotional issues helps resolve the fear of body sensations.
These participants will then be asked to spend the next 25 minutes writing about past emotional issues.
Participant writings are confidential and will not be viewed by the experimenter.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of Anxiety-Related Body Sensations
Time Frame: Immediately following the single-session intervention
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Anxiety Sensitivity Index - Revised Concerns Subscale (12 items)
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Immediately following the single-session intervention
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Fear of Anxiety-Related Body Sensations
Time Frame: One week after single-session intervention
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Anxiety Sensitivity Revised - Respiratory Concerns Subscale (12 items)
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One week after single-session intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypervigilance to anxiety-related body sensations
Time Frame: One week after the single-session intervention
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Body Vigilance Scale (4 items)
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One week after the single-session intervention
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Beck Anxiety Inventory
Time Frame: One week after the single-session intervention
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Beck Anxiety Inventory (21 items)
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One week after the single-session intervention
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Peak Anxiety During a Symptom Induction Task
Time Frame: Immediately following the single-session intervention
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Peak anxiety ratings during prolonged straw breathing
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Immediately following the single-session intervention
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Peak Anxiety During a Symptom Induction Task
Time Frame: One week after the single-session intervention
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Peak anxiety ratings during prolonged straw breathing
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One week after the single-session intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brett Deacon, Ph.D., University of Wyoming
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IEstudyUW
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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