iCBT With TMS in Patients With MDD

NCT05988619 | Completed Results FDA Device

• 1 other identifier: 19000581
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Depression; TMS; Brain Stimulation; Internet-Based CBT

Outcome Measures

Primary Outcomes (4)

• Hamilton Depression Rating Scale (HAM-D)

  Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)

  Baseline to Post-Treatment (6 weeks)

• Temporal Experience of Pleasure Scale (TEPS)

  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

• Inventory of Depressive Symptomatology (IDS)

  Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms)

  Baseline to Post-Treatment (6 weeks)

• Dimensional Anhedonia Rating Scale (DARS)

  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

Study Arms (2)

iCBT and TMS

ACTIVE COMPARATOR

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; Behavioral: Internet-Based Cognitive Behavioral Therapy

Psychoeducation and TMS

PLACEBO COMPARATOR

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; Behavioral: Psychoeducation

Interventions

Transcranial Magnetic Stimulation DEVICE

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.

Also known as: TMS

Psychoeducation and TMS; iCBT and TMS

Internet-Based Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: iCBT, This Way Up

iCBT and TMS

Psychoeducation BEHAVIORAL

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.

Also known as: Stories of the Mind

Psychoeducation and TMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA TMS Clinical and Research Service

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Benjamin Rosenberg
• Organization: Pomona College

benjamin.rosenberg@pomona.edu

408-458-5375

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: March 21, 2021
• Primary Completion: September 7, 2024
• Study Completion: September 7, 2024
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)