- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04455646
Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)
July 8, 2020 updated by: Brainsway
A naturalistic study design, in which dTMS patients will be randomized to get a free add-on CBT treatment.
The dTMS procedure will include treatment as usual, and participants will use the app from post randomization (Pre-treatment is defined as measures from the first three days of treatment) to the end of dTMS treatment (Post-treatment which is defined as measures from after twenty TMS sessions over a minimum of four weeks), and for an additional three months of FU (FU).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Participants will be recruited from those attending dTMS clinics around the world (i.e.,naturalistic study design), and consenting individuals (in person consent done in the clinic on paper) will be given a random user code.
This code will be specific for their version of the app, and the only link between their signature and the code will remain at the site for auditing purposes.
Participants will undergo treatment as usual of dTMS and will use GGDE twice a day.
Participants will be asked to complete demographic and clinical questionnaires via the GGDE app, and relevant clinical questionnaires will be re-administered following treatment and during FU.
The initial and all following dTMS sessions will involve patients going through the stimulation procedure (The operator will record stimulation variables such as individual patient's intensity of stimulation and coil location into GGDE) followed by 5 min of GGDE use.
The patient will indicate which statements (in that session) were most relevant and challenging to them, which will be followed by a pre-prepared psycho-education paragraph about the specific maladaptive belief addressed by the app that day.
The patient will then be prompted to use the app one more time at home during the same day.
Patient will continue similar use during FU, with two GGDE usage each day.
The naturalistic design will allow the accumulation of large quantities of data in a short period of time, aiming to optimize GGDE using machine learning.
Importantly, GGDE will allow the random allocation of users to different GGDE modules of the app (i.e., similar app versions with changes in specific parameters related to different depressive traits).
One out of the ten modules used in this trial will include neutral (placebo) stimuli requiring the user to respond to plus/minus signs rather than MDD relevant statements.
Study Type
Observational
Enrollment (Anticipated)
540
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aron Tendler, MD
- Phone Number: (561) 333-8884
- Email: aron.tendler@gmail.com
Study Contact Backup
- Name: Amit Ezra, MA
- Phone Number: +972503103134 +972503103134
- Email: amite@brainsway.com
Study Locations
-
-
California
-
San Diego, California, United States, 92037
- Recruiting
- Kadima Neuropsychiatry
-
Contact:
- David Feifel, MD
- Phone Number: 858-412-4130
- Email: dfeifel@kadimanp.com
-
-
Florida
-
Juno Beach, Florida, United States, 33408
- Recruiting
- Advanced Mental Health Care Inc. - Juno Beach
-
Contact:
- Elyssa Sisko
- Phone Number: 561-267-8876
- Email: elyssasisko@gmail.com
-
Palm Beach, Florida, United States, 33480
- Recruiting
- Advanced Mental Health Care Inc. - Palm Beach
-
Contact:
- Elyssa Sisko
- Phone Number: 561-333-8884
-
Contact:
- Phone Number: 561-386-1600
-
Principal Investigator:
- Aron Tendler
-
Royal Palm Beach, Florida, United States, 33411
- Recruiting
- Advanced Mental Health Care Inc. - Royal Palm Beach
-
Contact:
- Elyssa Sisko
- Phone Number: 561-267-8876
- Email: elyssasisko@gmail.com
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- Recruiting
- Greenbrook - Annapolis
-
Contact:
- Hanita Chhabra, MD
- Phone Number: 443-837-9645
- Email: sfox@greenbrooktms.com
-
Columbia, Maryland, United States, 21045
- Recruiting
- Greenbrook - Columbia
-
Contact:
- Misty Borst, MD
- Phone Number: 443-718-5206
- Email: mdraayer@greenbrooktms.com
-
Frederick, Maryland, United States, 21701
- Recruiting
- Greenbrook - Frederick
-
Contact:
- Joshua Sussal, MD
- Phone Number: 240-651-6824
- Email: dslim@greenbrooktms.com
-
Glen Burnie, Maryland, United States, 21061
- Recruiting
- Greenbrook - Glen Burnie
-
Contact:
- Hanita Chhabra, MD
- Phone Number: 443-577-3703
- Email: kkapoor@greenbrooktms.com
-
Greenbelt, Maryland, United States, 20770
- Recruiting
- Greenbrook - Greenbelt
-
Contact:
- Joshua Sussal, MD
- Phone Number: 240-542-0186
- Email: jkelley@greenbrooktms.com
-
Kensington, Maryland, United States, 20895
- Recruiting
- Greenbrook - Kensington
-
Contact:
- Geoffrey Grammer, MD
- Phone Number: 855-940-4867
- Email: bthompson@greenbrooktms.com
-
Olney, Maryland, United States, 20832
- Recruiting
- Greenbrook - Olney
-
Contact:
- Joshua Sussal, MD
- Phone Number: 301-476-0391
- Email: pdasilva@greenbrooktms.com
-
Rockville, Maryland, United States, 20850
- Recruiting
- Greenbrook - Rockville
-
Contact:
- Geoffrey Grammer, MD
- Phone Number: 855-940-4867
- Email: jliu@greenbrooktms.com
-
-
Missouri
-
O'Fallon, Missouri, United States, 63368
- Recruiting
- Greenbrook - O'Fallon
-
Contact:
- Howard Ilivicky, MD
- Phone Number: 314-497-9657
- Email: pfowler@greenbrooktms.com
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Saint Louis, Missouri, United States, 63128
- Recruiting
- Greenbrook - Tesson Ferry
-
Contact:
- Steven Harvey, MD
- Phone Number: 314-748-0091
- Email: pfowler@greenbrooktms.com
-
Saint Louis, Missouri, United States, 63141
- Recruiting
- Greenbrook - Creve Coeur
-
Contact:
- Robert Rifkin, MD
- Phone Number: 314-720-8561
- Email: pfowler@greenbrooktms.com
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27517
- Recruiting
- Greenbrook - Chapel Hill
-
Contact:
- Andrea Hernandez, MD
- Phone Number: 919-951-0271
- Email: sarnold@greenbrooktms.com
-
Greensboro, North Carolina, United States, 27410
- Recruiting
- Greenbrook - Greensboro
-
Contact:
- Keshavpal Reddy, MD
- Phone Number: 336-808-0986
- Email: wsellars@greenbrooktms.com
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Matthews, North Carolina, United States, 28105
- Recruiting
- Greenbrook - Matthews
-
Contact:
- Darlene Ifill-Taylor, MD
- Phone Number: 704-321-8252
- Email: cwilson@greenbrooktms.com
-
Raleigh, North Carolina, United States, 27607
- Recruiting
- Greenbrook - Raleigh
-
Contact:
- Kellie Tolin, MD
- Phone Number: 984-789-4739
- Email: mirvin@greenbrooktms.com
-
-
Virginia
-
Glen Allen, Virginia, United States, 23059
- Recruiting
- Greenbrook - Glen Allen
-
Contact:
- William Sauvé, MD
- Phone Number: 804-980-7520
- Email: hauerbach@greenbrooktms.com
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McLean, Virginia, United States, 22102
- Recruiting
- Greenbrook TMS NeuroHealth Centers
-
Contact:
- Jessica Oleksik
- Phone Number: 703-356-1568
- Email: joleksik@greenbrooktms.com
-
Contact:
- Kirsten Burke
- Phone Number: 703-356-1568
-
Principal Investigator:
- Geoffrey Grammer, MD
-
Newport News, Virginia, United States, 23606
- Recruiting
- Greenbook - Newport News
-
Contact:
- William Sauvé, MD
- Phone Number: 757-320-0224
- Email: rrose@greenbrooktms.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 68 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The intention is to enroll at least 540 patients diagnosed with MDD who were accepted into dTMS treatment for depression.
The patients will be of all racial, ethnic and gender categories.
The course of illness histories will be based upon patient reporting through the GGDE app.
Patients who are unlikely to show response based on the literature to date (presence of psychosis, co-morbid and prominent anxiety disorder or substance abuse, personality disorder or dysthymia) will not be asked to participate in the study.
Description
Inclusion Criteria:
- Adult outpatients accepted to treatment as usual dTMS with a Primary DSM-V diagnosis of Major Depression, single or recurrent episode
- Capable and willing to provide informed consent
- In a possession of a Smartphone capable of running the GGDE app.
- Able to adhere to the treatment schedule.
Exclusion Criteria:
Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Health Questionnaire (PHQ)
Time Frame: 1 year
|
The change from Pre- to Post-treatment in the Patient Health Questionnaire (PHQ) scores from baseline to endpoint.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Patient Health Questionnaire (PHQ)
Time Frame: 1 year
|
Response rate (50% reduction from Pre-treatment of the PHQ score), where the rate refers to the percentage of patients in response at Post-treatment.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 26, 2019
Primary Completion (ANTICIPATED)
August 26, 2021
Study Completion (ANTICIPATED)
August 26, 2021
Study Registration Dates
First Submitted
June 29, 2020
First Submitted That Met QC Criteria
June 29, 2020
First Posted (ACTUAL)
July 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 9, 2020
Last Update Submitted That Met QC Criteria
July 8, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101 (Hamilton Integrated Research Ethics Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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