Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)
1 other identifier
observational
540
1 country
22
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 26, 2019
CompletedFirst Submitted
Initial submission to the registry
June 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2021
CompletedJuly 9, 2020
June 1, 2020
2 years
June 29, 2020
July 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Health Questionnaire (PHQ)
The change from Pre- to Post-treatment in the Patient Health Questionnaire (PHQ) scores from baseline to endpoint.
1 year
Secondary Outcomes (1)
Patient Patient Health Questionnaire (PHQ)
1 year
Interventions
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).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brainswaylead
Study Sites (22)
Kadima Neuropsychiatry
San Diego, California, 92037, United States
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, 33408, United States
Advanced Mental Health Care Inc. - Palm Beach
Palm Beach, Florida, 33480, United States
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, 33411, United States
Greenbrook - Annapolis
Annapolis, Maryland, 21401, United States
Greenbrook - Columbia
Columbia, Maryland, 21045, United States
Greenbrook - Frederick
Frederick, Maryland, 21701, United States
Greenbrook - Glen Burnie
Glen Burnie, Maryland, 21061, United States
Greenbrook - Greenbelt
Greenbelt, Maryland, 20770, United States
Greenbrook - Kensington
Kensington, Maryland, 20895, United States
Greenbrook - Olney
Olney, Maryland, 20832, United States
Greenbrook - Rockville
Rockville, Maryland, 20850, United States
Greenbrook - O'Fallon
O'Fallon, Missouri, 63368, United States
Greenbrook - Tesson Ferry
St Louis, Missouri, 63128, United States
Greenbrook - Creve Coeur
St Louis, Missouri, 63141, United States
Greenbrook - Chapel Hill
Chapel Hill, North Carolina, 27517, United States
Greenbrook - Greensboro
Greensboro, North Carolina, 27410, United States
Greenbrook - Matthews
Matthews, North Carolina, 28105, United States
Greenbrook - Raleigh
Raleigh, North Carolina, 27607, United States
Greenbrook - Glen Allen
Glen Allen, Virginia, 23059, United States
Greenbrook TMS NeuroHealth Centers
McLean, Virginia, 22102, United States
Greenbook - Newport News
Newport News, Virginia, 23606, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2020
First Posted
July 2, 2020
Study Start
August 26, 2019
Primary Completion
August 26, 2021
Study Completion
August 26, 2021
Last Updated
July 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share