Exposure Therapy Consortium (ETC) for Anxiety Sensitivity

Sponsor

University of Texas at Austin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05225740

Collaborator

University of North Carolina, Chapel Hill (Other), University of Colorado, Boulder (Other), University of Miami (Other), University of Mississippi, Oxford (Other), Ruhr University of Bochum (Other), Boston University (Other), Fordham University (Other), The University of New South Wales (Other), Southern Methodist University (Other), Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg (Other), Technische Universität Dresden (Other), Curtin University (Other), Hebrew University of Jerusalem (Other)

600

Enrollment

Locations

Arms

Anticipated Duration (Months)

42.9

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Elevated Anxiety Sensitivity	Behavioral: Standard Exposure Behavioral: Stress Management Training Behavioral: Enhanced Exposure	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Large-group One-session Exposure Therapy Protocol for Targeting Anxiety Sensitivity

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control General stress reduction based on stress management training to help people cope with feelings of anxiety, used as an active control condition	Behavioral: Stress Management Training 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.
Active Comparator: Standard Exposure 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	Behavioral: Standard Exposure 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.
Experimental: Enhanced Exposure Psychoeducation about exposure therapy and anxiety sensitivity, interoceptive exposure therapy modeling and practice, and post-exposure processing aimed at emphasizing harm expectancy violation	Behavioral: Enhanced Exposure 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.

Arm

Intervention/Treatment

Active Comparator: Control

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

Behavioral: Stress Management Training

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.

Active Comparator: Standard Exposure

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

Behavioral: Standard Exposure

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.

Experimental: Enhanced Exposure

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

Behavioral: Enhanced Exposure

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.

Outcome Measures

Primary Outcome Measures

Anxiety Sensitivity [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).

Secondary Outcome Measures

Change in Anxiety Sensitivity [1 month]
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 [1 month]
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 [1 month]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Colorado at Boulder	Boulder	Colorado	United States	80309
2	The University of Miami	Miami	Florida	United States	33146
3	Boston Univesrity	Boston	Massachusetts	United States	02215
4	The University of Mississippi	Oxford	Mississippi	United States	38677
5	Fordham University	Bronx	New York	United States	10458
6	The University or North Caroline at Chapel Hill	Chapel Hill	North Carolina	United States	27514
7	The University of Texas at Austin	Austin	Texas	United States	78712
8	Southern Methodist University	Dallas	Texas	United States	75205
9	University of New South Wales	Kensington		Australia
10	Curtin University	Perth		Australia
11	Philipps-Universität Marburg	Marburg	Hesse	Germany
12	Ruhr-Universität Bochum	Bochum	Ruhr Region	Germany
13	Technische Universität Dresden	Dresden	Saxony	Germany
14	The Hebrew University of Jerusalem	Jerusalem		Israel

Sponsors and Collaborators

University of Texas at Austin
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

Investigators

Principal Investigator: Jasper Smits, PhD, The University of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jasper A. Smits, Principal Investigator, University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT05225740

Other Study ID Numbers:

2019-09-0153

First Posted:

Feb 4, 2022

Last Update Posted:

Mar 24, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jasper A. Smits, Principal Investigator, University of Texas at Austin

Exposure Therapy

Harm Expectancy Violation

Additional relevant MeSH terms:

Hypersensitivity

Anxiety Disorders

Study Results

No Results Posted as of Mar 24, 2022