Anxiety SensitivityNCT04259190
A Comparison of Treatment Rationales on Willingness to Tolerate Distress in Interoceptive Exposure
A study testing interoceptive exposure in people with Anxiety Sensitivity, run by Gina Boullion at 1 site in United States.
Trial summary
The purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention for the reduction of anxiety sensitivity. 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?
- interoceptive exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Aug 2022
- Phase
- Interventional
- 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 ≥ 23 on the Anxiety Sensitivity Index - 3 (ASI-3)
Who cannot join
- Seizures
- Hypertension
- Heart problems
- Current pregnancy
- Asthma
- Other health conditions exacerbated by intense exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi
University, Mississippi, 38677
About this study
Official title: Does a Values Rationale Increase Willingness to Tolerate Distress in Interoceptive Exposure: Examination of a One-Session Randomized Clinical Trial
The purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention for the reduction of anxiety sensitivity. A standard treatment rationale without values emphasis will serve as a control.
Read the detailed description
Cognitive behavioral models of panic disorder maintain that recurrent, unexpected panic attacks result from anxiety sensitivity, or the fear of anxiety-related physiological sensations (e.g., fear of increased heart rate) and catastrophic misinterpretations regarding the danger of those sensations (e.g., misinterpreting increased heart rate as an oncoming heart attack). From these models and subsequent clinical research, interoceptive exposure has emerged as the most efficacious component of cognitive behavioral therapy for panic disorder treatment and, as expected, an efficacious intervention for decreasing anxiety sensitivity. Nevertheless, small-to-moderate effect sizes, wide variability in response rates and dropout rates indicated that panic disorder treatments may benefit from modifications to improve upon retention, response rates, and symptom reduction.
Patient motivation and lack of engagement have been identified as factors to intervene upon. Numerous therapeutic techniques have been used to facilitate patient motivation in treatment; however, one specific direction that has gained increasing empirical interest is the inclusion of values identification. Values have been incorporated as a motivational component in empirically supported behavioral techniques and treatments, including Motivational Interviewing, Behavioral Activation Treatment for Depression packages, and Acceptance and Commitment Therapy. Evidence from randomized controlled trials have generally supported the inclusion of packages containing values components in facilitating exposure therapy, and preliminary evidence has specifically favored the inclusion of packages containing values components in exposure therapy in cognitive behavioral therapy for panic disorder. However, there is no research known by the author that examines the influence of values on motivation in interoceptive exposure. Therefore, research examining the effect of a values component in isolation motivation in and acceptability of interoceptive exposure exercises has the potential to further improve treatment efficacy reducing costs associated with panic disorder and the many other conditions treated by interoceptive exposure. Therefore, the purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention among a clinical analogue sample with elevated anxiety sensitivity.
- Conditions
- Anxiety Sensitivity
- Being tested
- interoceptive exposure
- Keywords
- anxiety sensitivity, panic, interoceptive exposure, exposure therapy, values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interoceptive exposureBehavioural
Repeated 60-second trials of voluntary hyperventilation, each followed by a 15-second rest period. Participants will complete a minimum of 8 trials and continue additional trials until ratings of their most feared predicted outcome fall less than or below 5% likelihood.
| Study group | Role | What they receive |
|---|---|---|
| Values rationale | Experimental | Interoceptive exposure exercises will be introduced as a way to help participants engage in more that they value. Receives: Behavioral: interoceptive exposure |
| Standard rationale | Active comparator | Interoceptive exposure exercises will be introduced as a way to help participants experience less discomfort. Receives: Behavioral: interoceptive exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to tolerate distress
Willingness to tolerate distress will be assessed by identifying the activity item on the Albany Panic and Phobia Questionnaire (APPQ) - Agoraphobia subscale to which the participant responded with the highest score indicating most fear. The participant will then be asked, "How willing would you be to do [most feared activity] next week?" Responses will range from 0% to 100%.
Measured: change from pre-intervention to immediately post-intervention
Secondary outcomes (7)
Straw breathing BAT peak fear ratings
Participants will be asked to engage in hyperventilation via breathing through a cocktail straw for three consecutive minutes pre-intervention. Participants will be asked to rate their peak fear ranging from 0 ("no fear") to 100 ("extreme fear or panic") on a 100-point visual analog scale after each minute. A peak fear rating will be calculated by computing the average of the three ratings.
Measured: pre-intervention
Overbreathing BAT peak fear ratings
Participants will be asked to engage in one last overbreathing task post-intervention to see how long they can overbreathe. After discontinuation, participants will be asked to report their current level of fear ranging from 0 ("no fear") to 100 ("extreme fear or panic") on a 100-point visual analog scale.
Measured: immediately post-intervention
Between trial fear ratings
After each voluntary hyperventilation trial, participants will be asked to provide ratings of their peak fear. Participants will be asked to rate their peak fear during the trial ranging from 0 ("no fear") to 100 ("extreme fear or panic") on a 100-point visual analog scale.
Measured: change from pre-intervention to immediately post-intervention
Anxiety Sensitivity Index - 3 (ASI-3)
The ASI-3 is an 18-item self-report measure of the fear of physiological arousal-related sensations. Scores on the ASI-3 can range from 0 to 72, with higher scores reflecting greater fear of arousal-related symptoms.
Measured: change from pre-intervention to immediately post-intervention
Albany Panic and Phobia Questionnaire (APPQ)
The APPQ is a 27-item self-report measure of the fear of activities often avoided by individuals with agoraphobia and social phobia, and activities that typically produce physical sensations. Scores on the APPQ can range from 0 to 216, with higher scores reflecting higher levels of fear.
Measured: change from pre-intervention to immediately post-intervention
Between trial tolerability ratings
After each voluntary hyperventilation trial, participants will be asked to provide ratings of tolerability of physiological sensations. Participants will be asked to rate the extent they perceived themselves as able to tolerate the physiological sensations during hyperventilation from 0 ("unable to tolerate them at all") to 100 ("completely able to tolerate them") on a 100-point visual analog scale.
Measured: change from pre-intervention to immediately post-intervention
Treatment Acceptability Questionnaire
A three-item self-report questionnaire was administered to participants to assess acceptability of the treatment provided. Participants will rate treatment acceptability, likeability, and aversiveness from "not at all" to "extremely" on a five-point Likert scale. Scores on the Treatment Acceptability Questionnaire can range from 0 to 12, with higher scores reflecting greater acceptability.
Measured: immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jun 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Why it stopped: Halted due to COVID-19.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gina Boullion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gina Boullion, University of Mississippi, Oxford
- Investigators
- Gina Boullion, M.S., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259190
- Sponsor's protocol ID
- 20-024
- Status last verified
- Jun 2020
- First submitted
- 31 Jan 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Values Rationale Increase Willingness to Tolerate Distress in Interoceptive Exposure: Examination of a One-Session Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04259190
- Acronym / sponsor ID
- 20-024
- Conditions
- Anxiety Sensitivity
- Keywords
- anxiety sensitivity, panic, interoceptive exposure, exposure therapy, values
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Halted due to COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gina BoullionUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 6 Feb 2020 (actual)
- 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.
The purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention for the reduction of anxiety sensitivity. A standard treatment rationale without values emphasis will serve as a control.
Detailed description
Cognitive behavioral models of panic disorder maintain that recurrent, unexpected panic attacks result from anxiety sensitivity, or the fear of anxiety-related physiological sensations (e.g., fear of increased heart rate) and catastrophic misinterpretations regarding the danger of those sensations (e.g., misinterpreting increased heart rate as an oncoming heart attack). From these models and subsequent clinical research, interoceptive exposure has emerged as the most efficacious component of cognitive behavioral therapy for panic disorder treatment and, as expected, an efficacious intervention for decreasing anxiety sensitivity. Nevertheless, small-to-moderate effect sizes, wide variability in response rates and dropout rates indicated that panic disorder treatments may benefit from modifications to improve upon retention, response rates, and symptom reduction.
Patient motivation and lack of engagement have been identified as factors to intervene upon. Numerous therapeutic techniques have been used to facilitate patient motivation in treatment; however, one specific direction that has gained increasing empirical interest is the inclusion of values identification. Values have been incorporated as a motivational component in empirically supported behavioral techniques and treatments, including Motivational Interviewing, Behavioral Activation Treatment for Depression packages, and Acceptance and Commitment Therapy. Evidence from randomized controlled trials have generally supported the inclusion of packages containing values components in facilitating exposure therapy, and preliminary evidence has specifically favored the inclusion of packages containing values components in exposure therapy in cognitive behavioral therapy for panic disorder. However, there is no research known by the author that examines the influence of values on motivation in interoceptive exposure. Therefore, research examining the effect of a values component in isolation motivation in and acceptability of interoceptive exposure exercises has the potential to further improve treatment efficacy reducing costs associated with panic disorder and the many other conditions treated by interoceptive exposure. Therefore, the purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention among a clinical analogue sample with elevated anxiety sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Values rationale | Experimental | Behavioral: interoceptive exposureInteroceptive exposure exercises will be introduced as a way to help participants engage in more that they value. |
| Standard rationale | Active comparator | Behavioral: interoceptive exposureInteroceptive exposure exercises will be introduced as a way to help participants experience less discomfort. |
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 ≥ 23 on the Anxiety Sensitivity Index - 3 (ASI-3)
Key exclusion criteria (6 listed)
- Seizures
- Hypertension
- Heart problems
- Current 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 |
|---|---|---|
| interoceptive exposureRepeated 60-second trials of voluntary hyperventilation, each followed by a 15-second rest period. Participants will complete a minimum of 8 trials and continue additional trials until ratings of their most feared predicted outcome fall less than or below 5% likelihood. | Behavioural | Standard rationale, Values rationale |
Primary outcome
Willingness to tolerate distress
Time frame: change from pre-intervention to immediately post-intervention
Willingness to tolerate distress will be assessed by identifying the activity item on the Albany Panic and Phobia Questionnaire (APPQ) - Agoraphobia subscale to which the participant responded with the highest score indicating most fear. The participant will then be asked, "How willing would you be to do [most feared activity] next week?" Responses will range from 0% to 100%.
7 secondary outcomes
Straw breathing BAT peak fear ratings
Time frame: pre-intervention
Overbreathing BAT peak fear ratings
Time frame: immediately post-intervention
Between trial fear ratings
Time frame: change from pre-intervention to immediately post-intervention
Anxiety Sensitivity Index - 3 (ASI-3)
Time frame: change from pre-intervention to immediately post-intervention
Albany Panic and Phobia Questionnaire (APPQ)
Time frame: change from pre-intervention to immediately post-intervention
Between trial tolerability ratings
Time frame: change from pre-intervention to immediately post-intervention
Treatment Acceptability Questionnaire
Time frame: immediately post-intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Gina Boullion, M.S. principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interoceptive exposure in people with Anxiety Sensitivity, run by Gina Boullion 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: withdrawn, as of the sponsor's last update on 26 Jun 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Willingness to tolerate distress (time frame: change from pre-intervention to immediately post-intervention). 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 26 Jun 2020.