Comparison of Methods for the Delivery of Interoceptive Exposure

NCT01201304 | Unknown Phase 2

• 1 other identifier: IEstudyUW
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Sensitivity

Keywords

Anxiety sensitivity; Panic

Outcome Measures

Primary Outcomes (2)

• Fear of Anxiety-Related Body Sensations

  Anxiety Sensitivity Index - Revised Concerns Subscale (12 items)

  Immediately following the single-session intervention

• Fear of Anxiety-Related Body Sensations

  Anxiety Sensitivity Revised - Respiratory Concerns Subscale (12 items)

  One week after single-session intervention

Secondary Outcomes (4)

• Hypervigilance to anxiety-related body sensations

  One week after the single-session intervention

• Beck Anxiety Inventory

  One week after the single-session intervention

• Peak Anxiety During a Symptom Induction Task

  Immediately following the single-session intervention

• Peak Anxiety During a Symptom Induction Task

  One week after the single-session intervention

Study Arms (2)

Interoceptive exposure

EXPERIMENTAL

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

Behavioral: Standard exposure; Behavioral: Enhanced exposure; Behavioral: Intensive exposure

Expressive writing

PLACEBO COMPARATOR

Expectancy control intervention.

Behavioral: Expressive writing

Interventions

Standard exposure BEHAVIORAL

Three 60-second trials of hyperventilation, each followed by diaphragmatic breathing, cognitive reappraisal, and prolonged rest until body sensations have subsided.

Interoceptive exposure

Enhanced exposure BEHAVIORAL

Three 60-second trials of hyperventilation, each followed by a 15-second rest period and cognitive reappraisal.

Interoceptive exposure

Intensive exposure BEHAVIORAL

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.

Interoceptive exposure

Expressive writing BEHAVIORAL

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.

Expressive writing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Score \> 21 on Anxiety Sensitivity Index - Revised Fear of Respiratory Symptoms Subscale.

You may not qualify if:

• Seizures
• Hypertension
• Heart problems
• Pregnancy
• Asthma
• Other health conditions exacerbated by intense exercise.

Sponsors & Collaborators

• University of Wyoming: lead

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82071, United States

Location

Study Officials

• Brett Deacon, Ph.D.

  University of Wyoming

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 14, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

US (1)