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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCBT and TMS | Active Comparator | 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. |
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| Psychoeducation and TMS | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) | Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms) | Baseline to Post-Treatment (6 weeks) |
| 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 |
| Inventory of Depressive Symptomatology (IDS) | Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms) | Baseline to Post-Treatment (6 weeks) |
| 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 |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA TMS Clinical and Research Service | Los Angeles | California | 90024 | United States |
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Excluded (n=60)
Arm 2 Lost to follow-up (no reason given) (n=4) Discontinued intervention (no reason given (3), COVID diagnosis mid-treatment (1), cited poor fit with intervention (2), repeated non-attendance at scheduled appointments (2), started CBT with outside therapist (1)) (n=9)
100 individuals were recruited and screened
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| ID | Title | Description |
|---|---|---|
| FG000 | iCBT and TMS | 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. 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. 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. |
| FG001 | Psychoeducation and TMS | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | iCBT and TMS | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Depression Rating Scale (HAM-D) | Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms) | Posted | Mean | Standard Deviation | score on a scale | Baseline to Post-Treatment (6 weeks) |
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Adverse events, if had occurred, would be collected during the first 6 weeks of enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iCBT and TMS | 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. 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Rosenberg | Pomona College | 408-458-5375 | benjamin.rosenberg@pomona.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2020 | Sep 29, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Care providers administering the TMS treatment are blinded and do not know whether the participant has been randomized to receive iCBT or educational content as a supplement to the TMS treatment.
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| Internet-Based Cognitive Behavioral Therapy | Behavioral | 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. |
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| Psychoeducation | Behavioral | 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. |
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| BG001 | Psychoeducation and TMS | 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. 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Psychoeducation and TMS | 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. 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. 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. |
|
|
| Primary | Temporal Experience of Pleasure Scale (TEPS) | Change in Depression Symptoms (Range = 0-108, higher indicates lower symptoms) | Posted | Mean | Standard Deviation | score on a scale | Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up |
|
|
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| Primary | Inventory of Depressive Symptomatology (IDS) | Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms) | Posted | Mean | Standard Deviation | score on a scale | Baseline to Post-Treatment (6 weeks) |
|
|
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| Primary | Dimensional Anhedonia Rating Scale (DARS) | Change in Depression Symptoms (Range = 0-130, higher indicates lower symptoms) | Posted | Mean | Standard Deviation | score on a scale | Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up |
|
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Psychoeducation and TMS | 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. 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. 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D001519 |
| Behavior |
| 6 months |
|
| 9 months |
|
| 6 months |
|
| 9 months |
|