Exposure Therapy Consortium (ETC) for Anxiety Sensitivity

NCT05225740 | Completed

• 1 other identifier: 2019-09-0153
• Study Type: interventional
• Target: 399
• Locations: 4 countries
• Sites: 12

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.

Conditions

Elevated Anxiety Sensitivity

Keywords

Exposure Therapy; Harm Expectancy Violation

Outcome Measures

Primary Outcomes (1)

• 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).

  1 day

Secondary Outcomes (3)

• Change in Anxiety Sensitivity

  1 month

• Depression

  1 month

• Anxiety

  1 month

Study Arms (3)

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

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

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

Behavioral: Enhanced Exposure

Interventions

Standard Exposure BEHAVIORAL

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.

Standard Exposure

Stress Management Training BEHAVIORAL

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.

Control

Enhanced Exposure BEHAVIORAL

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.

Enhanced Exposure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• University of North Carolina, Chapel Hill: collaborator
• University of Colorado, Boulder: collaborator
• University of Miami: collaborator
• University of Mississippi, Oxford: collaborator
• Ruhr University of Bochum: collaborator
• Boston University: collaborator
• Fordham University: collaborator
• The University of New South Wales: collaborator
• Southern Methodist University: collaborator
• Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg: collaborator
• Technische Universität Dresden: collaborator
• Curtin University: collaborator
• Hebrew University of Jerusalem: collaborator
• University of Göttingen: collaborator

Study Sites (12)

The University of Colorado at Boulder

Boulder, Colorado, 80309, United States

Location

The University of Miami

Miami, Florida, 33146, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

The University of Mississippi

Oxford, Mississippi, 38677, United States

Location

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

University of New South Wales

Kensington, Australia

Location

Curtin University

Perth, Australia

Location

Philipps-Universität Marburg

Marburg, Hesse, Germany

Location

Ruhr-Universität Bochum

Bochum, Ruhr Region, Germany

Location

Technische Universität Dresden

Dresden, Saxony, Germany

Location

University of Göttingen

Göttingen, Germany

Location

The Hebrew University of Jerusalem

Jerusalem, Israel

Location

Study Officials

• Jasper Smits, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: February 4, 2022
• Study Start: October 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (5); AU (2); DE (4); IL (1)