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iCBT With TMS in Patients With MDD

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Internet-Based Cognitive Behavioral Therapy
Psychoeducation
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, TMS, Brain Stimulation, Internet-Based CBT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with Major Depressive Disorder who are receiving a full course of TMS treatment in at the UCLA TMS Clinic. Eligibility is determined by TMS physicians who are co-investigators on this study. Exclusion Criteria: Any indications of metal implants, pregnancy, psychosis, autism spectrum disorders, complex regional pain syndromes, substance use dependence and comorbidities that would interfere with treatment response. The criteria are assessed using MINI interview and Hamilton Depression scale conducted by trained and certified interviewers. Participants may not participate if they are currently completing CBT outside of the study.

Sites / Locations

  • UCLA TMS Clinical and Research ServiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

iCBT and TMS

Psychoeducation and TMS

Arm Description

All participants complete six weeks of TMS treatment (five days per week) within the UCLA TMS Clinic. Participants in this condition additionally access iCBT materials and attend a weekly session for 30 minutes with a trained mental health coach to discuss iCBT content.

All participants complete six weeks of TMS treatment (five days per week) within the UCLA TMS Clinic. Participants in this condition additionally access educational materials about mental health and attend a weekly session for 30 minutes with a trained mental health coach to discuss educational content.

Outcomes

Primary Outcome Measures

Change in Depression Symptoms
Change in depression symptoms as measured by the Hamilton Depression Rating Scale (HAM-D), Dimensional Anhedonia Rating Scale (DARS), Temporal Experience of Pleasure Scale (TEPS), Inventory of Depressive Symptomatology (IDS), and Sheehan Disability Scale (SDS).

Secondary Outcome Measures

Full Information

First Posted
August 4, 2023
Last Updated
August 4, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05988619
Brief Title
iCBT With TMS in Patients With MDD
Official Title
Combined Internet-Based Cognitive Behavioral Therapy With Transcranial Magnetic Stimulation for Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Major Depressive Disorder (MDD) is a common mental health diagnosis. While there are many approaches to the treatment of MDD, current treatments of MDD often do not substantially reduce depressive symptoms among those in need of care. Prior research suggests that combining cognitive-behavioral therapy (CBT) and psychopharmacology can produce optimal treatment outcomes compared to the use of either treatment individually. Transcranial Magnetic Stimulation (TMS) is one promising brain stimulation approach used to treat MDD, especially among patients with treatment-resistant symptoms. Like psychopharmacological interventions, TMS may produce optimal treatment outcomes when paired with CBT. However, standard TMS protocols are time-intensive, typically requiring daily doctor visits for one hour of six to eight weeks. Therefore, an internet-delivered CBT protocol may augment the effects of TMS without substantially increasing patient burden. To that end, the present study assesses if a combined TMS and internet-delivered CBT protocol may produce superior treatment outcomes compared with TMS alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, TMS, Brain Stimulation, Internet-Based CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Care providers administering the TMS treatment are blinded and do not know whether the participant has been randomized to receive iCBT or educational content as a supplement to the TMS treatment.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iCBT and TMS
Arm Type
Active Comparator
Arm Description
All participants complete six weeks of TMS treatment (five days per week) within the UCLA TMS Clinic. Participants in this condition additionally access iCBT materials and attend a weekly session for 30 minutes with a trained mental health coach to discuss iCBT content.
Arm Title
Psychoeducation and TMS
Arm Type
Placebo Comparator
Arm Description
All participants complete six weeks of TMS treatment (five days per week) within the UCLA TMS Clinic. Participants in this condition additionally access educational materials about mental health and attend a weekly session for 30 minutes with a trained mental health coach to discuss educational content.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Intervention Description
TMS is a noninvasive method of brain stimulation administered by physicians in the UCLA TMS Clinical and Research Service. It is an FDA-approved treatment for Major Depressive Disorder.
Intervention Type
Behavioral
Intervention Name(s)
Internet-Based Cognitive Behavioral Therapy
Other Intervention Name(s)
iCBT, This Way Up
Intervention Description
This Way Up is an internet-based cognitive behavioral therapy (iCBT) for depression and anxiety. Participants learn about depression and anxiety symptoms, as well as behavioral strategies for addressing these symptoms. Participants are provided with homework exercises designed to help them engage in these strategies regularly.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Other Intervention Name(s)
Stories of the Mind
Intervention Description
Stories of the Mind is an educational program that is freely available through the Public Broadcast Service (PBS). Participants view video testimonials in which individuals describe their personal experiences across a variety of mental health concerns.
Primary Outcome Measure Information:
Title
Change in Depression Symptoms
Description
Change in depression symptoms as measured by the Hamilton Depression Rating Scale (HAM-D), Dimensional Anhedonia Rating Scale (DARS), Temporal Experience of Pleasure Scale (TEPS), Inventory of Depressive Symptomatology (IDS), and Sheehan Disability Scale (SDS).
Time Frame
Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with Major Depressive Disorder who are receiving a full course of TMS treatment in at the UCLA TMS Clinic. Eligibility is determined by TMS physicians who are co-investigators on this study. Exclusion Criteria: Any indications of metal implants, pregnancy, psychosis, autism spectrum disorders, complex regional pain syndromes, substance use dependence and comorbidities that would interfere with treatment response. The criteria are assessed using MINI interview and Hamilton Depression scale conducted by trained and certified interviewers. Participants may not participate if they are currently completing CBT outside of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin M Rosenberg, PhD
Phone
310-825-7471
Email
benrosenberg@g.ucla.edu
Facility Information:
Facility Name
UCLA TMS Clinical and Research Service
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew F Leuchter, MD
Phone
310-825-7471
Email
UCLATMS@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Andrew F Leuchter, MD
First Name & Middle Initial & Last Name & Degree
Michelle G Craske, PhD
First Name & Middle Initial & Last Name & Degree
Benjamin M Rosenberg, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

iCBT With TMS in Patients With MDD

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