iCBT With TMS in Patients With MDD

University of California, Los Angeles40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Internet-Based Cognitive Behavioral TherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale (HAM-D)

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

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

Temporal Experience of Pleasure Scale (TEPS)

Change in Depression Symptoms (Range = 0-108, higher indicates lower symptoms)

Time frame: 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)