iCBT With TMS in Patients With MDD

September 29, 2025 updated by: Ben Rosenberg, University of California, Los Angeles

Combined Internet-Based Cognitive Behavioral Therapy With Transcranial Magnetic Stimulation for Patients With Major Depressive Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA TMS Clinical and Research Service

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iCBT and TMS
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.
Device: Transcranial Magnetic Stimulation
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.
Other Names:
  • TMS
Behavioral: Internet-Based Cognitive Behavioral Therapy
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.
Other Names:
  • iCBT
  • This Way Up
Placebo Comparator: Psychoeducation and TMS
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.
Device: Transcranial Magnetic Stimulation
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.
Other Names:
  • TMS
Behavioral: Psychoeducation
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.
Other Names:
  • Stories of the Mind

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dimensional Anhedonia Rating Scale (DARS)
Time Frame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Change in Depression Symptoms (Range = 0-130, higher indicates lower symptoms)
Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Temporal Experience of Pleasure Scale (TEPS)
Time Frame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Change in Depression Symptoms (Range = 0-108, higher indicates lower symptoms)
Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Hamilton Depression Rating Scale (HAM-D)
Time Frame: Baseline to Post-Treatment (6 weeks)
Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)
Baseline to Post-Treatment (6 weeks)
Inventory of Depressive Symptomatology (IDS)
Time Frame: Baseline to Post-Treatment (6 weeks)
Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms)
Baseline to Post-Treatment (6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder (GAD-7)
Time Frame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Change in Anxiety Symptoms (Range = 0-21, higher indicates greater symptoms)
Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up

Collaborators and Investigators

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

Sponsor

University of California, Los Angeles

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)

March 21, 2021

Primary Completion (Actual)

September 7, 2024

Study Completion (Actual)

September 7, 2024

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19000581

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

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.

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