Clinical trial NCT05988619: iCBT With TMS in Patients With MDD
Official title: Combined Internet-Based Cognitive Behavioral Therapy With Transcranial Magnetic Stimulation for Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
TMS
Brain Stimulation
Internet-Based CBT
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
measure: Dimensional Anhedonia Rating Scale (DARS)
timeFrame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
measure: Temporal Experience of Pleasure Scale (TEPS)
timeFrame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
measure: Inventory of Depressive Symptomatology (IDS)
timeFrame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Secondary outcomes:
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA TMS Clinical and Research Service
state: California
Study officials:
References: