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

Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04455646
• Other study ID #: 101
• Status: Recruiting
• Start date: August 26, 2019
• Est. completion date: August 26, 2021

Study information

• Verified date: June 2020
• Source: Brainsway
• Contact: Aron Tendler, MD
• Phone: (561) 333-8884
• Email: aron.tendler[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: August 26, 2021
• Est. primary completion date: August 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 68 Years

Eligibility

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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Related Conditions & MeSH terms

• Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment
• Depression
• Depressive Disorder, Major

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Greenbrook - Annapolis	Annapolis	Maryland
United States	Greenbrook - Chapel Hill	Chapel Hill	North Carolina
United States	Greenbrook - Columbia	Columbia	Maryland
United States	Greenbrook - Frederick	Frederick	Maryland
United States	Greenbrook - Glen Allen	Glen Allen	Virginia
United States	Greenbrook - Glen Burnie	Glen Burnie	Maryland
United States	Greenbrook - Greenbelt	Greenbelt	Maryland
United States	Greenbrook - Greensboro	Greensboro	North Carolina
United States	Advanced Mental Health Care Inc. - Juno Beach	Juno Beach	Florida
United States	Greenbrook - Kensington	Kensington	Maryland
United States	Greenbrook - Matthews	Matthews	North Carolina
United States	Greenbrook TMS NeuroHealth Centers	McLean	Virginia
United States	Greenbook - Newport News	Newport News	Virginia
United States	Greenbrook - O'Fallon	O'Fallon	Missouri
United States	Greenbrook - Olney	Olney	Maryland
United States	Advanced Mental Health Care Inc. - Palm Beach	Palm Beach	Florida
United States	Greenbrook - Raleigh	Raleigh	North Carolina
United States	Greenbrook - Rockville	Rockville	Maryland
United States	Advanced Mental Health Care Inc. - Royal Palm Beach	Royal Palm Beach	Florida
United States	Greenbrook - Creve Coeur	Saint Louis	Missouri
United States	Greenbrook - Tesson Ferry	Saint Louis	Missouri
United States	Kadima Neuropsychiatry	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Brainsway

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year