iCBT With TMS in Patients With MDD

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT05988619
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-21
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Primary Completion: 2024-09-07
• Study Completion: 2024-09-07
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dimensional Anhedonia Rating Scale (DARS)	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)
Hamilton Depression Rating Scale (HAM-D)	Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up	Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)
Temporal Experience of Pleasure Scale (TEPS)	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)
Inventory of Depressive Symptomatology (IDS)	Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up	Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms)

Secondary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder (GAD-7)	Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up	Change in Anxiety Symptoms (Range = 0-21, higher indicates greater symptoms)

Trial Locations

Locations (1)

UCLA TMS Clinical and Research Service; 🇺🇸 Los Angeles, California, United States