Clinical trial NCT04455646: Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)
Official title: Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment
Lead sponsor: Brainsway
Sponsor class: INDUSTRY
First posted: 2020-07-02
Enrollment: 540
Sex: ALL
Minimum age (years): 22
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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).

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.

Eligibility criteria: 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).

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Primary outcomes:
measure: Patient Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Health Questionnaire (PHQ)
timeFrame: 1 year
Secondary outcomes:
measure: Patient Patient Health Questionnaire (PHQ)
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kadima Neuropsychiatry
state: California
city: Juno Beach
country: United States
facility: Advanced Mental Health Care Inc. - Juno Beach
state: Florida
city: Palm Beach
country: United States
facility: Advanced Mental Health Care Inc. - Palm Beach
state: Florida
city: Royal Palm Beach
country: United States
facility: Advanced Mental Health Care Inc. - Royal Palm Beach
state: Florida
city: Annapolis
country: United States
facility: Greenbrook - Annapolis
state: Maryland
city: Columbia
country: United States
facility: Greenbrook - Columbia
state: Maryland
city: Frederick
country: United States
facility: Greenbrook - Frederick
state: Maryland
city: Glen Burnie
country: United States
facility: Greenbrook - Glen Burnie
state: Maryland
city: Greenbelt
country: United States
facility: Greenbrook - Greenbelt
state: Maryland
city: Kensington
country: United States
facility: Greenbrook - Kensington
state: Maryland
city: Olney
country: United States
facility: Greenbrook - Olney
state: Maryland
city: Rockville
country: United States
facility: Greenbrook - Rockville
state: Maryland
city: O'Fallon
country: United States
facility: Greenbrook - O'Fallon
state: Missouri
city: Saint Louis
country: United States
facility: Greenbrook - Tesson Ferry
state: Missouri
city: Saint Louis
country: United States
facility: Greenbrook - Creve Coeur
state: Missouri
city: Chapel Hill
country: United States
facility: Greenbrook - Chapel Hill
state: North Carolina
city: Greensboro
country: United States
facility: Greenbrook - Greensboro
state: North Carolina
city: Matthews
country: United States
facility: Greenbrook - Matthews
state: North Carolina
city: Raleigh
country: United States
facility: Greenbrook - Raleigh
state: North Carolina
city: Glen Allen
country: United States
facility: Greenbrook - Glen Allen
state: Virginia
city: McLean
country: United States
facility: Greenbrook TMS NeuroHealth Centers
state: Virginia
city: Newport News
country: United States
facility: Greenbook - Newport News
state: Virginia
Study officials:
References: