iCBT With TMS in Patients With MDD

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Psychoeducation; Device: Transcranial Magnetic Stimulation; Behavioral: Internet-Based Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05988619

19000581

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

iCBT and TMS

Active Comparator group

Description:

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.

Treatment:

Behavioral: Internet-Based Cognitive Behavioral Therapy

Device: Transcranial Magnetic Stimulation

Psychoeducation and TMS

Placebo Comparator group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation

Behavioral: Psychoeducation