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Comparison of Methods for the Delivery of Interoceptive Exposure

Primary Purpose

Anxiety Sensitivity

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard exposure
Enhanced exposure
Intensive exposure
Expressive writing
Sponsored by
University of Wyoming
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Sensitivity focused on measuring Anxiety sensitivity, Panic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wyoming

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Interoceptive exposure

Expressive writing

Arm Description

Repeated trials of voluntary hyperventilation intended to reduce fears of arousal-related body sensations.

Expectancy control intervention.

Outcomes

Primary Outcome Measures

Fear of Anxiety-Related Body Sensations
Anxiety Sensitivity Index - Revised Concerns Subscale (12 items)
Fear of Anxiety-Related Body Sensations
Anxiety Sensitivity Revised - Respiratory Concerns Subscale (12 items)

Secondary Outcome Measures

Hypervigilance to anxiety-related body sensations
Body Vigilance Scale (4 items)
Beck Anxiety Inventory
Beck Anxiety Inventory (21 items)
Peak Anxiety During a Symptom Induction Task
Peak anxiety ratings during prolonged straw breathing
Peak Anxiety During a Symptom Induction Task
Peak anxiety ratings during prolonged straw breathing

Full Information

First Posted
September 9, 2010
Last Updated
January 26, 2012
Sponsor
University of Wyoming
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1. Study Identification

Unique Protocol Identification Number
NCT01201304
Brief Title
Comparison of Methods for the Delivery of Interoceptive Exposure
Official Title
Comparison of Methods for the Delivery of Interoceptive Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wyoming

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares the relative efficacy of three methods of delivering interoceptive exposure for the reduction of elevated anxiety sensitivity. The interventions vary according to their intensity and use of coping strategies during exposure. An expressive writing intervention serves as an expectancy control.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Sensitivity
Keywords
Anxiety sensitivity, Panic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interoceptive exposure
Arm Type
Experimental
Arm Description
Repeated trials of voluntary hyperventilation intended to reduce fears of arousal-related body sensations.
Arm Title
Expressive writing
Arm Type
Placebo Comparator
Arm Description
Expectancy control intervention.
Intervention Type
Behavioral
Intervention Name(s)
Standard exposure
Intervention Description
Three 60-second trials of hyperventilation, each followed by diaphragmatic breathing, cognitive reappraisal, and prolonged rest until body sensations have subsided.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced exposure
Intervention Description
Three 60-second trials of hyperventilation, each followed by a 15-second rest period and cognitive reappraisal.
Intervention Type
Behavioral
Intervention Name(s)
Intensive exposure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Expressive writing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fear of Anxiety-Related Body Sensations
Description
Anxiety Sensitivity Index - Revised Concerns Subscale (12 items)
Time Frame
Immediately following the single-session intervention
Title
Fear of Anxiety-Related Body Sensations
Description
Anxiety Sensitivity Revised - Respiratory Concerns Subscale (12 items)
Time Frame
One week after single-session intervention
Secondary Outcome Measure Information:
Title
Hypervigilance to anxiety-related body sensations
Description
Body Vigilance Scale (4 items)
Time Frame
One week after the single-session intervention
Title
Beck Anxiety Inventory
Description
Beck Anxiety Inventory (21 items)
Time Frame
One week after the single-session intervention
Title
Peak Anxiety During a Symptom Induction Task
Description
Peak anxiety ratings during prolonged straw breathing
Time Frame
Immediately following the single-session intervention
Title
Peak Anxiety During a Symptom Induction Task
Description
Peak anxiety ratings during prolonged straw breathing
Time Frame
One week after the single-session intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Deacon, Ph.D.
Organizational Affiliation
University of Wyoming
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wyoming
City
Laramie
State/Province
Wyoming
ZIP/Postal Code
82071
Country
United States

12. IPD Sharing Statement

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Comparison of Methods for the Delivery of Interoceptive Exposure

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