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

July 8, 2020 updated by: Brainsway
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • Recruiting
        • Kadima Neuropsychiatry
        • Contact:
    • Florida
      • Juno Beach, Florida, United States, 33408
        • Recruiting
        • Advanced Mental Health Care Inc. - Juno Beach
        • Contact:
      • Palm Beach, Florida, United States, 33480
        • Recruiting
        • Advanced Mental Health Care Inc. - Palm Beach
        • Contact:
          • Elyssa Sisko
          • Phone Number: 561-333-8884
        • Contact:
          • Phone Number: 561-386-1600
        • Principal Investigator:
          • Aron Tendler
      • Royal Palm Beach, Florida, United States, 33411
        • Recruiting
        • Advanced Mental Health Care Inc. - Royal Palm Beach
        • Contact:
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Greenbrook - Annapolis
        • Contact:
      • Columbia, Maryland, United States, 21045
      • Frederick, Maryland, United States, 21701
        • Recruiting
        • Greenbrook - Frederick
        • Contact:
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Greenbrook - Glen Burnie
        • Contact:
      • Greenbelt, Maryland, United States, 20770
      • Kensington, Maryland, United States, 20895
      • Olney, Maryland, United States, 20832
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Greenbrook - Rockville
        • Contact:
    • Missouri
      • O'Fallon, Missouri, United States, 63368
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Greenbrook - Tesson Ferry
        • Contact:
      • Saint Louis, Missouri, United States, 63141
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Recruiting
        • Greenbrook - Chapel Hill
        • Contact:
      • Greensboro, North Carolina, United States, 27410
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • Greenbrook - Matthews
        • Contact:
      • Raleigh, North Carolina, United States, 27607
    • Virginia
      • Glen Allen, Virginia, United States, 23059
      • McLean, Virginia, United States, 22102
        • Recruiting
        • Greenbrook TMS NeuroHealth Centers
        • Contact:
        • Contact:
          • Kirsten Burke
          • Phone Number: 703-356-1568
        • Principal Investigator:
          • Geoffrey Grammer, MD
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Greenbook - Newport News
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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).

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Patient Health Questionnaire (PHQ)
Time Frame: 1 year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brainsway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 26, 2019

Primary Completion (ANTICIPATED)

August 26, 2021

Study Completion (ANTICIPATED)

August 26, 2021

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (ACTUAL)

July 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101 (Hamilton Integrated Research Ethics Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment

  • Fudan University
    Merck Sharp & Dohme LLC
    Withdrawn
    Social Media-based Vaccine Confidence and Hesitancy Monitoring
    Data Collection | Machine Learning | Patient Acceptance of Health Care | Vaccination Refusal | Internet-Based Intervention | Immunization Programs | Information Dissemination | Social Medium
  • King Saud University
    Completed
    Novel Gentic Variations Contributing to Asthma Susceptability in Saudi Arabia
    Collection of Clinical Data That Will be Used in This Study and Will Form a Data Bank for Asthma in Saudi Arabia | Identify Known and NOVEL Genetic Risk Factors Contributing to Asthma Susceptibility | Study the Mechanistic Roles of the Genetic Variants Within Major Asthma Susceptibility...
    Saudi Arabia

Clinical Trials on CBT-based, mobile-delivered, intervention platform

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe