Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05225740




Registration number
NCT05225740
Ethics application status
Date submitted
17/05/2021
Date registered
4/02/2022
Date last updated
1/02/2024

Titles & IDs
Public title
Exposure Therapy Consortium (ETC) for Anxiety Sensitivity
Scientific title
Large-group One-session Exposure Therapy Protocol for Targeting Anxiety Sensitivity
Secondary ID [1] 0 0
2019-09-0153
Universal Trial Number (UTN)
Trial acronym
ETC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elevated Anxiety Sensitivity 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Standard Exposure
Behaviour - Stress Management Training
Behaviour - Enhanced Exposure

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

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

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


Behaviour: 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.

Behaviour: 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.

Behaviour: 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.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anxiety Sensitivity
Timepoint [1] 0 0
1 day
Secondary outcome [1] 0 0
Change in Anxiety Sensitivity
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Depression
Timepoint [2] 0 0
1 month
Secondary outcome [3] 0 0
Anxiety
Timepoint [3] 0 0
1 month

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of New South Wales - Kensington
Recruitment hospital [2] 0 0
Curtin University - Perth
Recruitment postcode(s) [1] 0 0
- Kensington
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Mississippi
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Germany
State/province [8] 0 0
Hesse
Country [9] 0 0
Germany
State/province [9] 0 0
Ruhr Region
Country [10] 0 0
Germany
State/province [10] 0 0
Saxony
Country [11] 0 0
Germany
State/province [11] 0 0
Göttingen
Country [12] 0 0
Israel
State/province [12] 0 0
Jerusalem

Funding & Sponsors
Primary sponsor type
Other
Name
University of Texas at Austin
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of North Carolina, Chapel Hill
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Colorado, Boulder
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Miami
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Mississippi, Oxford
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Ruhr University of Bochum
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Boston University
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Fordham University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
The University of New South Wales
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Southern Methodist University
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Technische Universität Dresden
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Curtin University
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Hebrew University of Jerusalem
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
University of Göttingen
Address [14] 0 0
Country [14] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05225740
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jasper Smits, PhD
Address 0 0
The University of Texas at Austin
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jasper Smits, PhD
Address 0 0
Country 0 0
Phone 0 0
512-475-8095
Fax 0 0
Email 0 0
smits@utexas.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05225740