Elevated Anxiety SensitivityETCNCT05225740
Exposure Therapy Consortium (ETC) for Anxiety Sensitivity
A study testing Standard Exposure, Stress Management Training and Enhanced Exposure in people with Elevated Anxiety Sensitivity, run by University of Texas at Austin at 12 sites in 4 countries.
Trial summary
The current study seeks to test differences between a single-session large-group format of standard exposure, enhanced exposure, and a control condition in treating anxiety sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Anxiety Sensitivity
- What is being tested?
- Standard Exposure, Stress Management Training and Enhanced Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 1 Oct 2022to 1 Jul 2024
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-70
- Students currently enrolled in enrolled in an introductory psychology course a psychology course
- Elevated anxiety sensitivity (total ASI-3 score ≥ 23)
Who cannot join
- History of respiratory or cardiovascular conditions (e.g., asthma, high blood pressure), neurological disorders (e.g., epilepsy), current pregnancy, or medical problems (e.g., inner ear problems, back or joint problems) that may interfere with an ability complete interoceptive exposure procedures
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States5 sites
The University of Texas at Austin
Austin, Texas, 78712
Boston University
Boston, Massachusetts, 02215
The University of Colorado at Boulder
Boulder, Colorado, 80309
The University of Miami
Miami, Florida, 33146
The University of Mississippi
Oxford, Mississippi, 38677
Germany4 sites
Ruhr-Universität Bochum
Bochum, Ruhr Region
Technische Universität Dresden
Dresden, Saxony
University of Göttingen
Göttingen
Philipps-Universität Marburg
Marburg, Hesse
Australia2 sites
University of New South Wales
Kensington
Curtin University
Perth
About this study
Official title: Large-group One-session Exposure Therapy Protocol for Targeting Anxiety Sensitivity
The current study seeks to test differences between a single-session large-group format of standard exposure, enhanced exposure, and a control condition in treating anxiety sensitivity. It is hypothesized that 1) participants assigned to either exposure condition will evidence greater reductions in anxiety sensitivity from pre-treatment to posttreatment relative to those in the control condition; 2) participants assigned to the enhanced exposure condition will evidence greater reductions in anxiety sensitivity from pre-treatment to posttreatment relative to those in the standard exposure condition. The investigators will test putative moderators and mechanisms of action. Prior to initiating the study for purposes of data analyses, the investigators will pilot study procedures during Spring 2020.
Read the detailed description
Anxiety sensitivity (AS), or the fear of anxiety and related sensations, represents an individual difference variable implicated in the risk and maintenance of anxiety and related disorders. Best conceptualized as an amplification factor, AS, when elevated, interacts with changes in bodily sensations (e.g., racing heart, sweating, dizziness) to produce fear. Exposure therapy involves repeated confrontation to feared cues to help individuals reestablish a sense of safety around these cues. Exposure therapy is a transdiagnostic treatment strategy that has shown to be efficacious across anxiety and related disorders. Symptom induction exercises (e.g., spinning, voluntary hyperventilation, straw breathing, using a tongue depressor) are useful for providing exposure to benign bodily sensations (e.g., dizziness, racing heart, breathlessness, choking), allowing individuals with elevated AS to learn that, while perhaps uncomfortable, these sensations are not harmful, but safe.
In an effort to increase the access to exposure therapy, Margraf and colleagues developed a large-group one-session exposure therapy protocols involving brief psychoeducation followed by either observation or participation in exposure practice for fears of various cues, including spiders, dental procedures, and blood, injuries and injections. Initial testing indicates feasibility and shows that individuals participating in these protocols evidence significant improvement in anxiety symptoms.
The current study involves the development and testing of a large-group one-session exposure therapy protocol designed to target AS. The investigators will compare two variants of the protocol and include a general stress reduction protocol as a control condition (CONTROL). The first variant (STANDARD) is a standard protocol, modeled after those developed by Margraf and colleagues, that includes a combination of psychoeducation (about the nature and [exposure] therapy of anxiety sensitivity) and interoceptive exposure therapy modeling and practice. The second variant (ENHANCED) is identical to the first but also includes post-exposure practice processing aimed at facilitating threat reappraisal (i.e., safety learning). All interventions will be delivered in large-group format (N ≥ 25 participants) by a team of clinicians (N = 3) trained in the delivery of exposure therapy. In an effort to improve the quality of research on exposure therapy, another central aim of this study is to examine the feasibility of an exposure therapy consortium. The investigators have established a network of research sites (N=11) with expertise in exposure therapy. With UT as the coordinating site, the investigators propose to implement the study protocol at each of these sites, allowing us to obtain the data needed to examine replication and the identification of predictors, moderators and mediators of treatment effects.
- Conditions
- Elevated Anxiety Sensitivity
- Being tested
- Standard Exposure, Stress Management Training, Enhanced Exposure
- Keywords
- Exposure Therapy, Harm Expectancy Violation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ExposureBehavioural
The standard intervention will include an orientation and psychoeducation phase, an exposure practice phase consisting five repeated trials per each of the three exposure exercises, and a post-exposure exercise. The post-exposure exercise will involve completing a set of questions regarding the exercises and the group experience.
Stress Management TrainingBehavioural
Stress management training (SMT) is designed to help people better cope with feelings of anxiety that accompany high levels of anxiety sensitivity. SMT will involve group instruction in healthy ways to experience and cope with stress whenever difficult situations arise. Participants will teach participants ways to maintain a healthy lifestyle, targeting things like nutrition, exercise, and sleep hygiene. This intervention will also involve progressive muscle relaxation training.
Enhanced ExposureBehavioural
The enhanced intervention will include an orientation and psychoeducation phase, an exposure practice phase consisting five repeated trials per each of the three exposure exercises, and a processing exercise. The post-processing exercise will involve completing a set of questions that will highlight harm expectancy violations.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | General stress reduction based on stress management training to help people cope with feelings of anxiety, used as an active control condition Receives: Behavioral: Stress Management Training |
| Standard Exposure | Active comparator | Psychoeducation about exposure therapy and anxiety sensitivity, interoceptive exposure therapy modeling and practice, and completion of questions about the exercises and the large-group aspect Receives: Behavioral: Standard Exposure |
| Enhanced Exposure | Experimental | Psychoeducation about exposure therapy and anxiety sensitivity, interoceptive exposure therapy modeling and practice, and post-exposure processing aimed at emphasizing harm expectancy violation Receives: Behavioral: Enhanced Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Sensitivity
The primary outcome is Anxiety Sensitivity at the posttreatment endpoint. Anxiety Sensitivity will be measured with the Anxiety Sensitivity Index-3 scale (ASI-3; 0-72, lower scores mean better outcome).
Measured: 1 day
Secondary outcomes (3)
Change in Anxiety Sensitivity
Pretreatment to follow-up change in Anxiety Sensitivity as indexed by scores on the Anxiety Sensitivity Index-3 scale (ASI-3; 0-72, lower scores mean better outcome)
Measured: 1 month
Depression
Pretreatment to follow-up change in Depressed Mood as indexed by scores on the Patient Health Questionnaire-8 scale (PHQ-8; 0-24, lower scores mean better outcome)
Measured: 1 month
Anxiety
Pretreatment to follow-up change in Anxiety as indexed by scores on the Generalized Anxiety Disorder-7 scale (GAD-7; 0-21, lower scores mean better outcome)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Oct 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated 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
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Colorado, Boulder, University of Miami, University of Mississippi, Oxford, Ruhr University of Bochum, Boston University, Fordham University, The University of New South Wales, Southern Methodist University, Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg, Technische Universität Dresden, Curtin University, Hebrew University of Jerusalem, University of Göttingen
- Responsible party
- Principal investigator, Jasper A. Smits, University of Texas at Austin
- Investigators
- Jasper Smits, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225740
- Sponsor's protocol ID
- 2019-09-0153
- Acronym
- ETC
- Status last verified
- Apr 2025
- First submitted
- 17 May 2021
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon completion of data collection, data from all sites will be pooled and analysis will take place at UT. All data will be encrypted with numeric codes so that no identifying information will be included in analyses. The data, in aggregate form only, may be used for future research or be made available to other researchers for research purposes not detailed in this study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large-group One-session Exposure Therapy Protocol for Targeting Anxiety Sensitivity
- ClinicalTrials.gov ID
- NCT05225740
- Acronym / sponsor ID
- ETC / 2019-09-0153
- Conditions
- Elevated Anxiety Sensitivity
- Keywords
- Exposure Therapy, Harm Expectancy Violation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Colorado, Boulder, University of Miami, University of Mississippi, Oxford, Ruhr University of Bochum, Boston University, Fordham University, The University of New South Wales, Southern Methodist University, Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg, Technische Universität Dresden, Curtin University, Hebrew University of Jerusalem, University of Göttingen
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 4 Feb 2022 (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 current study seeks to test differences between a single-session large-group format of standard exposure, enhanced exposure, and a control condition in treating anxiety sensitivity. It is hypothesized that 1) participants assigned to either exposure condition will evidence greater reductions in anxiety sensitivity from pre-treatment to posttreatment relative to those in the control condition; 2) participants assigned to the enhanced exposure condition will evidence greater reductions in anxiety sensitivity from pre-treatment to posttreatment relative to those in the standard exposure condition. The investigators will test putative moderators and mechanisms of action. Prior to initiating the study for purposes of data analyses, the investigators will pilot study procedures during Spring 2020.
Detailed description
Anxiety sensitivity (AS), or the fear of anxiety and related sensations, represents an individual difference variable implicated in the risk and maintenance of anxiety and related disorders. Best conceptualized as an amplification factor, AS, when elevated, interacts with changes in bodily sensations (e.g., racing heart, sweating, dizziness) to produce fear. Exposure therapy involves repeated confrontation to feared cues to help individuals reestablish a sense of safety around these cues. Exposure therapy is a transdiagnostic treatment strategy that has shown to be efficacious across anxiety and related disorders. Symptom induction exercises (e.g., spinning, voluntary hyperventilation, straw breathing, using a tongue depressor) are useful for providing exposure to benign bodily sensations (e.g., dizziness, racing heart, breathlessness, choking), allowing individuals with elevated AS to learn that, while perhaps uncomfortable, these sensations are not harmful, but safe.
In an effort to increase the access to exposure therapy, Margraf and colleagues developed a large-group one-session exposure therapy protocols involving brief psychoeducation followed by either observation or participation in exposure practice for fears of various cues, including spiders, dental procedures, and blood, injuries and injections. Initial testing indicates feasibility and shows that individuals participating in these protocols evidence significant improvement in anxiety symptoms.
The current study involves the development and testing of a large-group one-session exposure therapy protocol designed to target AS. The investigators will compare two variants of the protocol and include a general stress reduction protocol as a control condition (CONTROL). The first variant (STANDARD) is a standard protocol, modeled after those developed by Margraf and colleagues, that includes a combination of psychoeducation (about the nature and [exposure] therapy of anxiety sensitivity) and interoceptive exposure therapy modeling and practice. The second variant (ENHANCED) is identical to the first but also includes post-exposure practice processing aimed at facilitating threat reappraisal (i.e., safety learning). All interventions will be delivered in large-group format (N ≥ 25 participants) by a team of clinicians (N = 3) trained in the delivery of exposure therapy. In an effort to improve the quality of research on exposure therapy, another central aim of this study is to examine the feasibility of an exposure therapy consortium. The investigators have established a network of research sites (N=11) with expertise in exposure therapy. With UT as the coordinating site, the investigators propose to implement the study protocol at each of these sites, allowing us to obtain the data needed to examine replication and the identification of predictors, moderators and mediators of treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Stress Management TrainingGeneral stress reduction based on stress management training to help people cope with feelings of anxiety, used as an active control condition |
| Standard Exposure | Active comparator | Behavioral: Standard ExposurePsychoeducation about exposure therapy and anxiety sensitivity, interoceptive exposure therapy modeling and practice, and completion of questions about the exercises and the large-group aspect |
| Enhanced Exposure | Experimental | Behavioral: Enhanced ExposurePsychoeducation about exposure therapy and anxiety sensitivity, interoceptive exposure therapy modeling and practice, and post-exposure processing aimed at emphasizing harm expectancy violation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-70
- Students currently enrolled in enrolled in an introductory psychology course a psychology course
- Elevated anxiety sensitivity (total ASI-3 score ≥ 23)
Key exclusion criteria (1 listed)
- History of respiratory or cardiovascular conditions (e.g., asthma, high blood pressure), neurological disorders (e.g., epilepsy), current pregnancy, or medical problems (e.g., inner ear problems, back or joint problems) that may interfere with an ability complete interoceptive exposure procedures
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 ExposureThe standard intervention will include an orientation and psychoeducation phase, an exposure practice phase consisting five repeated trials per each of the three exposure exercises, and a post-exposure exercise. The post-exposure exercise will involve completing a set of questions regarding the exercises and the group experience. | Behavioural | Standard Exposure |
| Stress Management TrainingStress management training (SMT) is designed to help people better cope with feelings of anxiety that accompany high levels of anxiety sensitivity. SMT will involve group instruction in healthy ways to experience and cope with stress whenever difficult situations arise. Participants will teach participants ways to maintain a healthy lifestyle, targeting things like nutrition, exercise, and sleep hygiene. This intervention will also involve progressive muscle relaxation training. | Behavioural | Control |
| Enhanced ExposureThe enhanced intervention will include an orientation and psychoeducation phase, an exposure practice phase consisting five repeated trials per each of the three exposure exercises, and a processing exercise. The post-processing exercise will involve completing a set of questions that will highlight harm expectancy violations. | Behavioural | Enhanced Exposure |
Primary outcome
Anxiety Sensitivity
Time frame: 1 day
The primary outcome is Anxiety Sensitivity at the posttreatment endpoint. Anxiety Sensitivity will be measured with the Anxiety Sensitivity Index-3 scale (ASI-3; 0-72, lower scores mean better outcome).
3 secondary outcomes
Change in Anxiety Sensitivity
Time frame: 1 month
Depression
Time frame: 1 month
Anxiety
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: Undecided. Upon completion of data collection, data from all sites will be pooled and analysis will take place at UT. All data will be encrypted with numeric codes so that no identifying information will be included in analyses. The data, in aggregate form only, may be used for future research or be made available to other researchers for research purposes not detailed in this study.
Related trials for Elevated Anxiety Sensitivity
RecruitingPhase 3
Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.
Nicotine Dependence
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.
Jasper Smits, PhD principal investigator
The University of Texas at Austin
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Exposure, Stress Management Training and Enhanced Exposure in people with Elevated Anxiety Sensitivity, run by University of Texas at Austin at 12 sites in 4 countries.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Australia, Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety Sensitivity (time frame: 1 day). 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 29 Apr 2025.