Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)

Last updated: N/A
Sponsor: BRAINSWAY
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Depression (Adult And Geriatric)

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT04455646
101
  • Ages 22-68
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult outpatients accepted to treatment as usual dTMS with a Primary DSM-V diagnosisof 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

Exclusion Criteria: Investigators, site personnel directly affiliated with this study, and their immediatefamilies (immediate family is defined as a spouse, parent, child or sibling, whether bybirth or legal adoption).

Study Design

Total Participants: 540
Study Start date:
August 26, 2019
Estimated Completion Date:
August 26, 2021

Study 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.

Connect with a study center

  • Kadima Neuropsychiatry

    San Diego, California 92037
    United States

    Active - Recruiting

  • Advanced Mental Health Care Inc. - Juno Beach

    Juno Beach, Florida 33408
    United States

    Active - Recruiting

  • Advanced Mental Health Care Inc. - Palm Beach

    Palm Beach, Florida 33480
    United States

    Active - Recruiting

  • Advanced Mental Health Care Inc. - Royal Palm Beach

    Royal Palm Beach, Florida 33411
    United States

    Active - Recruiting

  • Greenbrook - Annapolis

    Annapolis, Maryland 21401
    United States

    Active - Recruiting

  • Greenbrook - Columbia

    Columbia, Maryland 21045
    United States

    Active - Recruiting

  • Greenbrook - Frederick

    Frederick, Maryland 21701
    United States

    Active - Recruiting

  • Greenbrook - Glen Burnie

    Glen Burnie, Maryland 21061
    United States

    Active - Recruiting

  • Greenbrook - Greenbelt

    Greenbelt, Maryland 20770
    United States

    Active - Recruiting

  • Greenbrook - Kensington

    Kensington, Maryland 20895
    United States

    Active - Recruiting

  • Greenbrook - Olney

    Olney, Maryland 20832
    United States

    Active - Recruiting

  • Greenbrook - Rockville

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Greenbrook - O'Fallon

    O'Fallon, Missouri 63368
    United States

    Active - Recruiting

  • Greenbrook - Creve Coeur

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Greenbrook - Tesson Ferry

    Saint Louis, Missouri 63128
    United States

    Active - Recruiting

  • Greenbrook - Chapel Hill

    Chapel Hill, North Carolina 27517
    United States

    Active - Recruiting

  • Greenbrook - Greensboro

    Greensboro, North Carolina 27410
    United States

    Active - Recruiting

  • Greenbrook - Matthews

    Matthews, North Carolina 28105
    United States

    Active - Recruiting

  • Greenbrook - Raleigh

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Greenbrook - Glen Allen

    Glen Allen, Virginia 23059
    United States

    Active - Recruiting

  • Greenbrook TMS NeuroHealth Centers

    McLean, Virginia 22102
    United States

    Active - Recruiting

  • Greenbook - Newport News

    Newport News, Virginia 23606
    United States

    Active - Recruiting

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