Recruiting

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

Sponsor:

Brainsway

Code:

NCT04455646

Conditions

Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment

Eligibility Criteria

Sex: All

Age: 22 - 68

Healthy Volunteers: Not accepted

Interventions

CBT-based, mobile-delivered, intervention platform

Study Details

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).

Conditions

Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment

Study ID

NCT04455646

Start date

Aug 26, 2019

Status verified date

Jun, 2020

Completion date

Aug 26, 2021

Anticipated

Primary completion date

Aug 26, 2021

Anticipated

Eligibility Criteria

Sex: All

Age: 22 - 68

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

540 participants

Anticipated

Interventions and Outcome Measures

Interventions

CBT-based, mobile-delivered, intervention platform

App of this platform have been shown to be associated with reduced psychopathology symptoms,including depressive symptoms, following treatment (i.e., relapse prevention). GGDE, which was specifically designed to address MDD related maladaptive beliefs and symptoms,includes different CBT-based intervention modules (nine active and one sham), as well as means for data collection and response monitoring. The active treatment modules will differ in the proportion of adaptive vs. maladaptive statements and the emphasis on particular content (e.g loneliness vs. hopelessness).

Primary outcome measure

Patient Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Health Questionnaire (PHQ) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Aron Tendler, MD

(561) 333-8884 aron.tendler@gmail.com

Amit Ezra, MA

+972503103134 amite@brainsway.com

Locations

Kadima Neuropsychiatry

Recruiting

San Diego, California, United States, 92037

Contacts

David Feifel, MD

858-412-4130 dfeifel@kadimanp.com

Principal Investigator:

David Feifel, MD

Advanced Mental Health Care Inc. - Juno Beach

Recruiting

Juno Beach, Florida, United States, 33408

Contacts

Elyssa Sisko

561-267-8876 elyssasisko@gmail.com

Principal Investigator:

Aron Tendler, MD

Advanced Mental Health Care Inc. - Palm Beach

Recruiting

Palm Beach, Florida, United States, 33480

Contacts

Elyssa Sisko

561-333-8884

561-386-1600

Principal Investigator:

Aron Tendler

Advanced Mental Health Care Inc. - Royal Palm Beach

Recruiting

Royal Palm Beach, Florida, United States, 33411

Contacts

Elyssa Sisko

561-267-8876 elyssasisko@gmail.com

Principal Investigator:

Aron Tendler, MD

Greenbrook - Annapolis

Recruiting

Annapolis, Maryland, United States, 21401

Contacts

Hanita Chhabra, MD

443-837-9645 sfox@greenbrooktms.com

Greenbrook - Columbia

Recruiting

Columbia, Maryland, United States, 21045

Contacts

Misty Borst, MD

443-718-5206 mdraayer@greenbrooktms.com

Greenbrook - Frederick

Recruiting

Frederick, Maryland, United States, 21701

Contacts

Joshua Sussal, MD

240-651-6824 dslim@greenbrooktms.com

Greenbrook - Glen Burnie

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

Hanita Chhabra, MD

443-577-3703 kkapoor@greenbrooktms.com

Greenbrook - Greenbelt

Recruiting

Greenbelt, Maryland, United States, 20770

Contacts

Joshua Sussal, MD

240-542-0186 jkelley@greenbrooktms.com

Greenbrook - Kensington

Recruiting

Kensington, Maryland, United States, 20895

Contacts

Geoffrey Grammer, MD

855-940-4867 bthompson@greenbrooktms.com

Greenbrook - Olney

Recruiting

Olney, Maryland, United States, 20832

Contacts

Joshua Sussal, MD

301-476-0391 pdasilva@greenbrooktms.com

Greenbrook - Rockville

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Geoffrey Grammer, MD

855-940-4867 jliu@greenbrooktms.com

Greenbrook - O'Fallon

Recruiting

O'Fallon, Missouri, United States, 63368

Contacts

Howard Ilivicky, MD

314-497-9657 pfowler@greenbrooktms.com

Greenbrook - Tesson Ferry

Recruiting

Saint Louis, Missouri, United States, 63128

Contacts

Steven Harvey, MD

314-748-0091 pfowler@greenbrooktms.com

Greenbrook - Creve Coeur

Recruiting

Saint Louis, Missouri, United States, 63141

Contacts

Robert Rifkin, MD

314-720-8561 pfowler@greenbrooktms.com

Greenbrook - Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27517

Contacts

Andrea Hernandez, MD

919-951-0271 sarnold@greenbrooktms.com

Greenbrook - Greensboro

Recruiting

Greensboro, North Carolina, United States, 27410

Contacts

Keshavpal Reddy, MD

336-808-0986 wsellars@greenbrooktms.com

Greenbrook - Matthews

Recruiting

Matthews, North Carolina, United States, 28105

Contacts

Darlene Ifill-Taylor, MD

704-321-8252 cwilson@greenbrooktms.com

Greenbrook - Raleigh

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

Kellie Tolin, MD

984-789-4739 mirvin@greenbrooktms.com

Greenbrook - Glen Allen

Recruiting

Glen Allen, Virginia, United States, 23059

Contacts

William Sauvé, MD

804-980-7520 hauerbach@greenbrooktms.com

Greenbrook TMS NeuroHealth Centers

Recruiting

McLean, Virginia, United States, 22102

Contacts

Jessica Oleksik

703-356-1568 joleksik@greenbrooktms.com

Kirsten Burke

703-356-1568

Principal Investigator:

Geoffrey Grammer, MD

Greenbook - Newport News

Recruiting

Newport News, Virginia, United States, 23606

Contacts

William Sauvé, MD

757-320-0224 rrose@greenbrooktms.com

More Information

Sponsor

Brainsway

Last update posted

Jul 9, 2020

Last verified

Jun, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brainsway on 2020-07-09.