What side effects are associated with this type of intervention?

Transcranial Magnetic Stimulation (TMS) is generally well-tolerated, but some patients may experience mild side effects such as scalp discomfort, headaches, lightheadedness, tingling, and, rarely, seizures. Cognitive-Behavioral Therapy (CBT) is a psychological intervention with minimal physical side effects, though it may cause temporary emotional discomfort as patients confront and work through negative thought patterns. Combining TMS with CBT aims to enhance treatment outcomes while maintaining a manageable side effect profile.

What prior FDA approvals exist?

The FDA has approved Transcranial Magnetic Stimulation (TMS) for the treatment of treatment-resistant depression. TMS is a non-invasive brain stimulation technique that modulates neural activity. Cognitive-Behavioral Therapy (CBT), a psychological intervention aimed at changing negative thought patterns, is also a well-established treatment for depression. Combining TMS with internet-delivered CBT is being studied as a potentially superior treatment approach, leveraging the strengths of both modalities to improve outcomes for patients with major depressive disorder.

What other types of research exist?

Promising, novel alternatives to TMS combined with internet-delivered CBT for depression patients include: 1) Remote Electrical Neuromodulation (REN), which has shown efficacy in pain relief and is non-invasive. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which may be beneficial for acute treatment of episodic migraine and could be explored for depression. 3) Electroconvulsive Therapy (ECT), particularly for treatment-resistant cases, though it is more invasive. 4) Combining pharmacotherapy with digital CBT platforms, which can provide comprehensive care without the need for frequent in-person visits.

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Procedure

iCBT + TMS for Depression

N/A

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post-treatment (6 weeks), as well as 6-month and 9-month follow-up

Summary

This trial is testing a combination of Transcranial Magnetic Stimulation (TMS) and internet-delivered Cognitive Behavioral Therapy (CBT) for patients with Major Depressive Disorder (MDD) who haven't responded to standard treatments. TMS uses magnetic fields to stimulate brain areas involved in mood, while CBT helps change negative thinking patterns. The goal is to see if this combined approach works better than TMS alone.

Who is the study for?

This trial is for individuals with Major Depressive Disorder (MDD) already undergoing Transcranial Magnetic Stimulation (TMS) at the UCLA TMS Clinic. It's not suitable for pregnant individuals, those currently in external CBT programs, people with substance dependence, certain comorbidities, metal implants, psychosis, autism spectrum disorders or complex regional pain syndromes.

What is being tested?

The study is testing whether combining TMS with an internet-based Cognitive Behavioral Therapy (iCBT) and Psychoeducation provides better outcomes than TMS alone for treating MDD. The iCBT aims to enhance treatment without adding much burden on patients.

What are the potential side effects?

While specific side effects are not listed here, typical ones from TMS may include headaches or discomfort at the stimulation site. Internet-based CBT usually does not have physical side effects but can sometimes cause emotional distress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post-treatment (6 weeks), as well as 6-month and 9-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post-treatment (6 weeks), as well as 6-month and 9-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-treatment (6 weeks), as well as 6-month and 9-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dimensional Anhedonia Rating Scale (DARS)

Hamilton Depression Rating Scale (HAM-D)

Inventory of Depressive Symptomatology (IDS)

+1 more

Secondary study objectives

Generalized Anxiety Disorder (GAD-7)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: iCBT and TMSActive Control2 Interventions

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 II: Psychoeducation and TMSPlacebo Group2 Interventions

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Magnetic Stimulation (TMS) and Cognitive-Behavioral Therapy (CBT) are two common treatments for depression that work through different mechanisms. TMS is a non-invasive brain stimulation technique that uses magnetic fields to modulate neural activity in brain regions associated with mood regulation, such as the prefrontal cortex. This can help alleviate depressive symptoms by enhancing neural connectivity and activity. CBT is a psychological intervention that aims to change negative thought patterns and behaviors by teaching patients coping skills and strategies to manage their symptoms. Combining TMS and CBT can be particularly effective because TMS can provide immediate neural changes, making the brain more receptive to the cognitive restructuring facilitated by CBT. This dual approach addresses both the biological and psychological aspects of depression, offering a more comprehensive treatment.