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iCBT With TMS in Patients With MDD

NCT05988619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-29

Study results available
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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

Interventions

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.

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.

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-21
Primary Completion
2024-09-07
Completion
2024-09-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05988619 on ClinicalTrials.gov