iCBT With TMS in Patients With MDD

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05988619
• Other study ID #: 19000581
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 21, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Transcranial Magnetic Stimulation
TMS is a noninvasive method of brain stimulation administered by physicians in the UCLA TMS Clinical and Research Service. It is an FDA-approved treatment for Major Depressive Disorder.

Behavioral:
• Internet-Based Cognitive Behavioral Therapy
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.
• Psychoeducation
Stories of the Mind is an educational program that is freely available through the Public Broadcast Service (PBS). Participants view video testimonials in which individuals describe their personal experiences across a variety of mental health concerns.

Locations

Country	Name	City	State
United States	UCLA TMS Clinical and Research Service	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HAM-D)	Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)	Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Primary	Dimensional Anhedonia Rating Scale (DARS)	Change in Depression Symptoms (Range = 0-130, higher indicates lower symptoms)	Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Primary	Temporal Experience of Pleasure Scale (TEPS)	Change in Depression Symptoms (Range = 0-108, higher indicates lower symptoms)	Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Primary	Inventory of Depressive Symptomatology (IDS)	Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms)	Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Secondary	Generalized Anxiety Disorder (GAD-7)	Change in Anxiety Symptoms (Range = 0-21, higher indicates greater symptoms)	Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up