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OpenTrials
Completed

NCT Number: NCT05988619

iCBT With TMS in Patients With MDD

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA TMS Clinical and Research Service

Los Angeles, California, 90024, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: iCBT, This Way Up

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.

Other names: Stories of the Mind

Primary outcomes

  1. 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)

  2. 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)

  3. Inventory of Depressive Symptomatology (IDS)

    Time frame: Baseline to Post-Treatment (6 weeks)

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

  4. 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)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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