Comparison of Methods for the Delivery of Interoceptive Exposure

Anxiety Sensitivity Clinical Trial

Official title:

Comparison of Methods for the Delivery of Interoceptive Exposure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01201304
• Other study ID #: IEstudyUW
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: September 9, 2010
• Last updated: January 26, 2012
• Start date: January 2010
• Est. completion date: April 2012

Study information

• Verified date: January 2012
• Source: University of Wyoming
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Sensitivity

Intervention

Behavioral:
• Standard exposure
Three 60-second trials of hyperventilation, each followed by diaphragmatic breathing, cognitive reappraisal, and prolonged rest until body sensations have subsided.
• Enhanced exposure
Three 60-second trials of hyperventilation, each followed by a 15-second rest period and cognitive reappraisal.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Wyoming	Laramie	Wyoming

Sponsors (1)

Lead Sponsor	Collaborator
University of Wyoming

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of Anxiety-Related Body Sensations	Anxiety Sensitivity Index - Revised Concerns Subscale (12 items)	Immediately following the single-session intervention	No
Primary	Fear of Anxiety-Related Body Sensations	Anxiety Sensitivity Revised - Respiratory Concerns Subscale (12 items)	One week after single-session intervention	No
Secondary	Hypervigilance to anxiety-related body sensations	Body Vigilance Scale (4 items)	One week after the single-session intervention	No
Secondary	Beck Anxiety Inventory	Beck Anxiety Inventory (21 items)	One week after the single-session intervention	No
Secondary	Peak Anxiety During a Symptom Induction Task	Peak anxiety ratings during prolonged straw breathing	Immediately following the single-session intervention	No
Secondary	Peak Anxiety During a Symptom Induction Task	Peak anxiety ratings during prolonged straw breathing	One week after the single-session intervention	No