iCBT With TMS in Patients With MDD

NCT ID: NCT05988619

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-21
• Study Completion Date: 2024-09-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: 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.

Internet-Based Cognitive Behavioral Therapy

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: 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.

Psychoeducation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

TMS; iCBT; This Way Up; Stories of the Mind

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Ben Rosenberg

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCLA TMS Clinical and Research Service

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19000581

Identifier Type: -

Identifier Source: org_study_id