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Trial details imported from ClinicalTrials.gov

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




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

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
BEHAVIORAL - Standard Exposure
BEHAVIORAL - Stress Management Training
BEHAVIORAL - 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


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.

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.

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

Outcomes
Primary outcome [1] 0 0
Anxiety Sensitivity
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
1 day
Secondary outcome [1] 0 0
Change in Anxiety Sensitivity
Assessment method [1] 0 0
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)
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Depression
Assessment method [2] 0 0
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)
Timepoint [2] 0 0
1 month
Secondary outcome [3] 0 0
Anxiety
Assessment method [3] 0 0
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)
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
Active, not 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
Accrual to date
Final
399
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
Texas
Country [6] 0 0
Germany
State/province [6] 0 0
Hesse
Country [7] 0 0
Germany
State/province [7] 0 0
Ruhr Region
Country [8] 0 0
Germany
State/province [8] 0 0
Saxony
Country [9] 0 0
Germany
State/province [9] 0 0
Göttingen
Country [10] 0 0
Israel
State/province [10] 0 0
Jerusalem

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
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
Email 0 0
smits@utexas.edu
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05225740