Data Collection for Facilitation of Machine Learning Algorithm for Personalized TreatmentNCT04455646
Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)
An observational study of Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment, run by Brainsway at 22 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 68 years
- Conditions the study is for
- Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment
- What is being tested?
- CBT-based, mobile-delivered, intervention platform
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 540 participants
- Where
- 22 sitesUnited States
- Study dates
- 26 Aug 2019to 26 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
- -
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
Greenbrook - Annapolis
Annapolis, Maryland, 21401
Hanita Chhabra, MD, 443-837-9645, sfox@greenbrooktms.com
- Recruiting
Greenbrook - Chapel Hill
Chapel Hill, North Carolina, 27517
Andrea Hernandez, MD, 919-951-0271, sarnold@greenbrooktms.com
- Recruiting
Greenbrook - Columbia
Columbia, Maryland, 21045
Misty Borst, MD, 443-718-5206, mdraayer@greenbrooktms.com
- Recruiting
Greenbrook - Frederick
Frederick, Maryland, 21701
Joshua Sussal, MD, 240-651-6824, dslim@greenbrooktms.com
- Recruiting
Greenbrook - Glen Allen
Glen Allen, Virginia, 23059
William Sauvé, MD, 804-980-7520, hauerbach@greenbrooktms.com
- Recruiting
Greenbrook - Glen Burnie
Glen Burnie, Maryland, 21061
Hanita Chhabra, MD, 443-577-3703, kkapoor@greenbrooktms.com
- Recruiting
Greenbrook - Greenbelt
Greenbelt, Maryland, 20770
Joshua Sussal, MD, 240-542-0186, jkelley@greenbrooktms.com
- Recruiting
Greenbrook - Greensboro
Greensboro, North Carolina, 27410
Keshavpal Reddy, MD, 336-808-0986, wsellars@greenbrooktms.com
- Recruiting
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, 33408
Elyssa Sisko, 561-267-8876, elyssasisko@gmail.com
Aron Tendler, MD
- Recruiting
Greenbrook - Kensington
Kensington, Maryland, 20895
Geoffrey Grammer, MD, 855-940-4867, bthompson@greenbrooktms.com
- Recruiting
Greenbrook - Matthews
Matthews, North Carolina, 28105
Darlene Ifill-Taylor, MD, 704-321-8252, cwilson@greenbrooktms.com
- Recruiting
Greenbrook TMS NeuroHealth Centers
McLean, Virginia, 22102
Jessica Oleksik, 703-356-1568, joleksik@greenbrooktms.com
Kirsten Burke, 703-356-1568
- Recruiting
Greenbook - Newport News
Newport News, Virginia, 23606
William Sauvé, MD, 757-320-0224, rrose@greenbrooktms.com
- Recruiting
Greenbrook - O'Fallon
O'Fallon, Missouri, 63368
Howard Ilivicky, MD, 314-497-9657, pfowler@greenbrooktms.com
- Recruiting
Greenbrook - Olney
Olney, Maryland, 20832
Joshua Sussal, MD, 301-476-0391, pdasilva@greenbrooktms.com
- Recruiting
Advanced Mental Health Care Inc. - Palm Beach
Palm Beach, Florida, 33480
Elyssa Sisko, 561-333-8884
561-386-1600
- Recruiting
Greenbrook - Raleigh
Raleigh, North Carolina, 27607
Kellie Tolin, MD, 984-789-4739, mirvin@greenbrooktms.com
- Recruiting
Greenbrook - Rockville
Rockville, Maryland, 20850
Geoffrey Grammer, MD, 855-940-4867, jliu@greenbrooktms.com
- Recruiting
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, 33411
Elyssa Sisko, 561-267-8876, elyssasisko@gmail.com
Aron Tendler, MD
- Recruiting
Kadima Neuropsychiatry
San Diego, California, 92037
David Feifel, MD, 858-412-4130, dfeifel@kadimanp.com
David Feifel, MD
- Recruiting
Greenbrook - Tesson Ferry
St Louis, Missouri, 63128
Steven Harvey, MD, 314-748-0091, pfowler@greenbrooktms.com
- Recruiting
Greenbrook - Creve Coeur
St Louis, Missouri, 63141
Robert Rifkin, MD, 314-720-8561, pfowler@greenbrooktms.com
About this study
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).
Read the 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.
- Being tested
- CBT-based, mobile-delivered, intervention platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-based, mobile-delivered, intervention platformBehavioural
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Patient Patient Health Questionnaire (PHQ)
Response rate (50% reduction from Pre-treatment of the PHQ score), where the rate refers to the percentage of patients in response at Post-treatment.
- Remission rate (PHQ<5; [1]), where the rate refers to the percentage of patients in remission at Post-treatment,
- Response rate, Remission rate, and the change from Pre-treatment to FU in the PHQ score.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start26 Aug 2019
- Primary completion26 Aug 2021 (estimated)
- Study completion26 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data Collection for Facilitation of Machine Learning Algorithm for Personalized TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455646
- Sponsor's protocol ID
- 101
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)
- ClinicalTrials.gov ID
- NCT04455646
- Acronym / sponsor ID
- 101
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 26 Aug 2021 (estimated)
- Study completion
- 26 Aug 2021 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 22 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-based, mobile-delivered, intervention platformApp 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). | Behavioural | – |
Primary outcome
Patient Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Health Questionnaire (PHQ)
Time frame: 1 year
The change from Pre- to Post-treatment in the Patient Health Questionnaire (PHQ) scores from baseline to endpoint.
1 secondary outcome
Patient Patient Health Questionnaire (PHQ)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment, run by Brainsway at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aron Tendler, MD ((561) 333-8884, aron.tendler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Health Questionnaire (PHQ) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.