Clinical trial NCT05225740: Exposure Therapy Consortium (ETC) for Anxiety Sensitivity
Official title: Large-group One-session Exposure Therapy Protocol for Targeting Anxiety Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated Anxiety Sensitivity
Keywords: Exposure Therapy
Harm Expectancy Violation
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: University of Colorado, Boulder
name: University of Miami
name: University of Mississippi, Oxford
name: Ruhr University of Bochum
name: Boston University
name: Fordham University
name: The University of New South Wales
name: Southern Methodist University
name: Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg
name: Technische Universität Dresden
name: Curtin University
name: Hebrew University of Jerusalem
name: University of Göttingen
First posted: 2022-02-04
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Ages 18-70
* Students currently enrolled in enrolled in an introductory psychology course a psychology course
* Elevated anxiety sensitivity (total ASI-3 score ≥ 23)

Exclusion Criteria:

- 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

Primary outcomes:
measure: Anxiety Sensitivity
timeFrame: 1 day
Secondary outcomes:
measure: Change in Anxiety Sensitivity
timeFrame: 1 month
measure: Depression
timeFrame: 1 month
measure: Anxiety
timeFrame: 1 month
Other outcomes:
Locations:
city: Boulder
country: United States
facility: The University of Colorado at Boulder
state: Colorado
city: Miami
country: United States
facility: The University of Miami
state: Florida
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Oxford
country: United States
facility: The University of Mississippi
state: Mississippi
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
city: Kensington
country: Australia
facility: University of New South Wales
city: Perth
country: Australia
facility: Curtin University
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
state: Hesse
city: Bochum
country: Germany
facility: Ruhr-Universität Bochum
state: Ruhr Region
city: Dresden
country: Germany
facility: Technische Universität Dresden
state: Saxony
city: Göttingen
country: Germany
facility: University of Göttingen
city: Jerusalem
country: Israel
facility: The Hebrew University of Jerusalem
Study officials:
affiliation: The University of Texas at Austin
name: Jasper Smits, PhD
role: PRINCIPAL_INVESTIGATOR
References: