Comparison of Methods for the Delivery of Interoceptive Exposure

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Brett Deacon, University of Wyoming
ClinicalTrials.gov Identifier:
NCT01201304
First received: September 9, 2010
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Anxiety Sensitivity
Behavioral: Standard exposure
Behavioral: Enhanced exposure
Behavioral: Intensive exposure
Behavioral: Expressive writing
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Methods for the Delivery of Interoceptive Exposure

Resource links provided by NLM:


Further study details as provided by University of Wyoming:

Primary Outcome Measures:
  • Fear of Anxiety-Related Body Sensations [ Time Frame: Immediately following the single-session intervention ] [ Designated as safety issue: No ]
    Anxiety Sensitivity Index - Revised Concerns Subscale (12 items)

  • Fear of Anxiety-Related Body Sensations [ Time Frame: One week after single-session intervention ] [ Designated as safety issue: No ]
    Anxiety Sensitivity Revised - Respiratory Concerns Subscale (12 items)


Secondary Outcome Measures:
  • Hypervigilance to anxiety-related body sensations [ Time Frame: One week after the single-session intervention ] [ Designated as safety issue: No ]
    Body Vigilance Scale (4 items)

  • Beck Anxiety Inventory [ Time Frame: One week after the single-session intervention ] [ Designated as safety issue: No ]
    Beck Anxiety Inventory (21 items)

  • Peak Anxiety During a Symptom Induction Task [ Time Frame: Immediately following the single-session intervention ] [ Designated as safety issue: No ]
    Peak anxiety ratings during prolonged straw breathing

  • Peak Anxiety During a Symptom Induction Task [ Time Frame: One week after the single-session intervention ] [ Designated as safety issue: No ]
    Peak anxiety ratings during prolonged straw breathing


Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interoceptive exposure
Repeated trials of voluntary hyperventilation intended to reduce fears of arousal-related body sensations.
Behavioral: Standard exposure
Three 60-second trials of hyperventilation, each followed by diaphragmatic breathing, cognitive reappraisal, and prolonged rest until body sensations have subsided.
Behavioral: Enhanced exposure
Three 60-second trials of hyperventilation, each followed by a 15-second rest period and cognitive reappraisal.
Behavioral: Intensive exposure
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.
Placebo Comparator: Expressive writing
Expectancy control intervention.
Behavioral: Expressive writing
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201304

Locations
United States, Wyoming
University of Wyoming
Laramie, Wyoming, United States, 82071
Sponsors and Collaborators
University of Wyoming
Investigators
Principal Investigator: Brett Deacon, Ph.D. University of Wyoming
  More Information

No publications provided

Responsible Party: Brett Deacon, Associate Professor of Psychology, University of Wyoming
ClinicalTrials.gov Identifier: NCT01201304     History of Changes
Other Study ID Numbers: IEstudyUW
Study First Received: September 9, 2010
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wyoming:
Anxiety sensitivity
Panic

ClinicalTrials.gov processed this record on September 16, 2014