Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)
Purpose
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).
Condition
- Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment
Eligibility
- Eligible Ages
- Between 22 Years and 68 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Recruiting Locations
San Diego 5391811, California 5332921 92037
Juno Beach 4160604, Florida 4155751 33408
Palm Beach 4167505, Florida 4155751 33480
Elyssa Sisko
561-333-8884
Royal Palm Beach 4170617, Florida 4155751 33411
Annapolis 4347242, Maryland 4361885 21401
Columbia 4352053, Maryland 4361885 21045
Frederick 4355585, Maryland 4361885 21701
Glen Burnie 4356188, Maryland 4361885 21061
Greenbelt 4356847, Maryland 4361885 20770
Kensington 4359760, Maryland 4361885 20895
Olney 4364537, Maryland 4361885 20832
Rockville 4367175, Maryland 4361885 20850
O'Fallon 4401242, Missouri 4398678 63368
St Louis 4407066, Missouri 4398678 63128
St Louis 4407066, Missouri 4398678 63141
Chapel Hill 4460162, North Carolina 4482348 27517
Greensboro 4469146, North Carolina 4482348 27410
Matthews 4478334, North Carolina 4482348 28105
Raleigh 4487042, North Carolina 4482348 27607
Glen Allen 4761054, Virginia 6254928 23059
McLean 4772354, Virginia 6254928 22102
Newport News 4776024, Virginia 6254928 23606
More Details
- NCT ID
- NCT04455646
- Status
- Unknown status
- Sponsor
- Brainsway
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.