Anxiety SensitivityPhase 2NCT01201304
Comparison of Methods for the Delivery of Interoceptive Exposure
A Phase 2 study testing Standard exposure, Enhanced exposure and Intensive exposure in people with Anxiety Sensitivity, run by University of Wyoming at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Sensitivity
- What is being tested?
- Standard exposure, Enhanced exposure and Intensive exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score > 21 on Anxiety Sensitivity Index - Revised Fear of Respiratory Symptoms Subscale.
Who cannot join
- Seizures
- Hypertension
- Heart problems
- Pregnancy
- Asthma
- Other health conditions exacerbated by intense exercise.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety Sensitivity
- Being tested
- Standard exposure, Enhanced exposure, Intensive exposure, Expressive writing
- Keywords
- Anxiety sensitivity, Panic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard exposureBehavioural
Three 60-second trials of hyperventilation, each followed by diaphragmatic breathing, cognitive reappraisal, and prolonged rest until body sensations have subsided.
Enhanced exposureBehavioural
Three 60-second trials of hyperventilation, each followed by a 15-second rest period and cognitive reappraisal.
Intensive exposureBehavioural
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 writingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interoceptive exposure | Experimental | Repeated trials of voluntary hyperventilation intended to reduce fears of arousal-related body sensations. Receives: Behavioral: Standard exposure; Behavioral: Enhanced exposure; Behavioral: Intensive exposure |
| Expressive writing | Placebo comparator | Expectancy control intervention. Receives: Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Anxiety-Related Body Sensations
Anxiety Sensitivity Index - Revised Concerns Subscale (12 items)
Measured: Immediately following the single-session intervention
Fear of Anxiety-Related Body Sensations
Anxiety Sensitivity Revised - Respiratory Concerns Subscale (12 items)
Measured: One week after single-session intervention
Secondary outcomes (4)
Hypervigilance to anxiety-related body sensations
Body Vigilance Scale (4 items)
Measured: One week after the single-session intervention
Beck Anxiety Inventory
Beck Anxiety Inventory (21 items)
Measured: One week after the single-session intervention
Peak Anxiety During a Symptom Induction Task
Peak anxiety ratings during prolonged straw breathing
Measured: Immediately following the single-session intervention
Peak Anxiety During a Symptom Induction Task
Peak anxiety ratings during prolonged straw breathing
Measured: One week after the single-session intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Deacon, University of Wyoming
- Investigators
- Brett Deacon, Ph.D., Principal investigator, University of Wyoming
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201304
- Sponsor's protocol ID
- IEstudyUW
- Status last verified
- Jan 2012
- First submitted
- 9 Sep 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods for the Delivery of Interoceptive Exposure
- ClinicalTrials.gov ID
- NCT01201304
- Acronym / sponsor ID
- IEstudyUW
- Conditions
- Anxiety Sensitivity
- Keywords
- Anxiety sensitivity, Panic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interoceptive exposure | Experimental | Behavioral: Standard exposure, Behavioral: Enhanced exposure, Behavioral: Intensive exposureRepeated trials of voluntary hyperventilation intended to reduce fears of arousal-related body sensations. |
| Expressive writing | Placebo comparator | Behavioral: Expressive writingExpectancy control intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Score > 21 on Anxiety Sensitivity Index - Revised Fear of Respiratory Symptoms Subscale.
Key exclusion criteria (6 listed)
- Seizures
- Hypertension
- Heart problems
- Pregnancy
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard exposureThree 60-second trials of hyperventilation, each followed by diaphragmatic breathing, cognitive reappraisal, and prolonged rest until body sensations have subsided. | Behavioural | Interoceptive exposure |
| Enhanced exposureThree 60-second trials of hyperventilation, each followed by a 15-second rest period and cognitive reappraisal. | Behavioural | Interoceptive exposure |
| Intensive exposureMinimum 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. | Behavioural | Interoceptive exposure |
| Expressive writingIndividuals 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. | Behavioural | Expressive writing |
Primary outcome
Fear of Anxiety-Related Body Sensations
Time frame: Immediately following the single-session intervention
Anxiety Sensitivity Index - Revised Concerns Subscale (12 items)
Fear of Anxiety-Related Body Sensations
Time frame: One week after single-session intervention
Anxiety Sensitivity Revised - Respiratory Concerns Subscale (12 items)
4 secondary outcomes
Hypervigilance to anxiety-related body sensations
Time frame: One week after the single-session intervention
Beck Anxiety Inventory
Time frame: One week after the single-session intervention
Peak Anxiety During a Symptom Induction Task
Time frame: Immediately following the single-session intervention
Peak Anxiety During a Symptom Induction Task
Time frame: One week after the single-session intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Deacon, Ph.D. principal investigator
University of Wyoming
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard exposure, Enhanced exposure and Intensive exposure in people with Anxiety Sensitivity, run by University of Wyoming at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Anxiety-Related Body Sensations (time frame: Immediately following the single-session intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.