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Clinical Trials/NCT05988619
NCT05988619
Completed
Not Applicable

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

University of California, Los Angeles1 site in 1 country40 target enrollmentMarch 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
University of California, Los Angeles
Enrollment
40
Locations
1
Primary Endpoint
Hamilton Depression Rating Scale (HAM-D)
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 21, 2021
End Date
September 7, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ben Rosenberg

Postdoctoral Fellow

University of California, Los Angeles

Eligibility Criteria

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)

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

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

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)

Inventory of Depressive Symptomatology (IDS)

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

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

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)

Study Sites (1)

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