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Exposure Therapy Consortium (ETC) for Anxiety Sensitivity (ETC)

Primary Purpose

Elevated Anxiety Sensitivity

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard Exposure
Stress Management Training
Enhanced Exposure
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elevated Anxiety Sensitivity focused on measuring Exposure Therapy, Harm Expectancy Violation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Colorado at BoulderRecruiting
  • The University of MiamiRecruiting
  • Boston Univesrity
  • The University of Mississippi
  • Fordham University
  • The University or North Caroline at Chapel Hill
  • The University of Texas at AustinRecruiting
  • Southern Methodist University
  • University of New South Wales
  • Curtin University
  • Philipps-Universität MarburgRecruiting
  • Ruhr-Universität Bochum
  • Technische Universität Dresden
  • The Hebrew University of Jerusalem

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Control

Standard Exposure

Enhanced Exposure

Arm Description

General stress reduction based on stress management training to help people cope with feelings of anxiety, used as an active control condition

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

Psychoeducation about exposure therapy and anxiety sensitivity, interoceptive exposure therapy modeling and practice, and post-exposure processing aimed at emphasizing harm expectancy violation

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
May 17, 2021
Last Updated
May 8, 2023
Sponsor
University of Texas at Austin
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
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1. Study Identification

Unique Protocol Identification Number
NCT05225740
Brief Title
Exposure Therapy Consortium (ETC) for Anxiety Sensitivity
Acronym
ETC
Official Title
Large-group One-session Exposure Therapy Protocol for Targeting Anxiety Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elevated Anxiety Sensitivity
Keywords
Exposure Therapy, Harm Expectancy Violation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
General stress reduction based on stress management training to help people cope with feelings of anxiety, used as an active control condition
Arm Title
Standard Exposure
Arm Type
Active Comparator
Arm Description
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
Arm Title
Enhanced Exposure
Arm Type
Experimental
Arm Description
Psychoeducation about exposure therapy and anxiety sensitivity, interoceptive exposure therapy modeling and practice, and post-exposure processing aimed at emphasizing harm expectancy violation
Intervention Type
Behavioral
Intervention Name(s)
Standard Exposure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety Sensitivity
Description
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).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Change in Anxiety Sensitivity
Description
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)
Time Frame
1 month
Title
Depression
Description
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)
Time Frame
1 month
Title
Anxiety
Description
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)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Johnson, BS
Phone
817-729-9319
Email
davidjohnson1@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jasper Smits, PhD
Phone
512-475-8095
Email
smits@utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasper Smits, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Colorado at Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirk
Email
Alex.Kirk@colorado.edu
First Name & Middle Initial & Last Name & Degree
Joanna Arch, PhD
Facility Name
The University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Broos
Email
hannahbroos2@gmail.com
First Name & Middle Initial & Last Name & Degree
Kiara Timpano, PhD
Facility Name
Boston Univesrity
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Completed
Facility Name
The University of Mississippi
City
Oxford
State/Province
Mississippi
ZIP/Postal Code
38677
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clark
Email
hclark@go.olemiss.edu
First Name & Middle Initial & Last Name & Degree
Laura Dixon, PhD
Facility Name
Fordham University
City
Bronx
State/Province
New York
ZIP/Postal Code
10458
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedowitz
Email
apedowitz@fordham.edu
First Name & Middle Initial & Last Name & Degree
Dean McKay, PhD
Facility Name
The University or North Caroline at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ojalehto
Email
ojalehto@unc.edu
First Name & Middle Initial & Last Name & Degree
Jon Abromowitz, PhD
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johnson
Email
djdavidjhnsn@utexas.edu
First Name & Middle Initial & Last Name & Degree
Santiago Papini, MA
Facility Name
Southern Methodist University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosenfield
Email
drosenfi@mail.smu.edu
First Name & Middle Initial & Last Name & Degree
David Rosenfield, PhD
Facility Name
University of New South Wales
City
Kensington
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Newby
Email
j.newby@unsw.edu.au
First Name & Middle Initial & Last Name & Degree
Jill Newby, PhD
Facility Name
Curtin University
City
Perth
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
McEvoy
Email
peter.mcevoy@curtin.edu.au
First Name & Middle Initial & Last Name & Degree
Peter McEvoy, PhD
Facility Name
Philipps-Universität Marburg
City
Marburg
State/Province
Hesse
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wannemüller
Email
Andre.Wannemueller@ruhr-uni-bochum.de
First Name & Middle Initial & Last Name & Degree
Winfried Rief, PhD
Facility Name
Ruhr-Universität Bochum
City
Bochum
State/Province
Ruhr Region
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wannemüller
Email
Andre.Wannemueller@ruhr-uni-bochum.de
First Name & Middle Initial & Last Name & Degree
Juergen Margraf, PhD
Facility Name
Technische Universität Dresden
City
Dresden
State/Province
Saxony
Country
Germany
Individual Site Status
Completed
Facility Name
The Hebrew University of Jerusalem
City
Jerusalem
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huppert
Email
jonathan.huppert@mail.huji.ac.il
First Name & Middle Initial & Last Name & Degree
Jonathan Juppert, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
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.

Learn more about this trial

Exposure Therapy Consortium (ETC) for Anxiety Sensitivity

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