Major Depressive Disorder
Conditions
Keywords
Depression, TMS, Brain Stimulation, Internet-Based CBT
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.
Interventions
DEVICETranscranial 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.
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.
BEHAVIORALPsychoeducation
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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) | Baseline to Post-Treatment (6 weeks) | 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) | Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms) |
| 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) |
Countries
United States
Participant flow
Recruitment details
100 individuals were recruited and screened
Pre-assignment details
Excluded (n=60) * Not meeting inclusion criteria (n= 9) * Declined to participate (n=51) * Other reasons (n=0) 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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 9 |
Baseline characteristics
| Characteristic | iCBT and TMS | Psychoeducation and TMS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 18 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 15 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 16 Participants | 14 Participants | 30 Participants |
| Region of Enrollment United States | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 8 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Dimensional Anhedonia Rating Scale (DARS)
Change in Depression Symptoms (Range = 0-130, higher indicates lower symptoms)
Time frame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT and TMS | Dimensional Anhedonia Rating Scale (DARS) | 6 weeks | 90.2667 score on a scale | Standard Deviation 25.401 |
| iCBT and TMS | Dimensional Anhedonia Rating Scale (DARS) | Baseline | 78.125 score on a scale | Standard Deviation 15.5258 |
| iCBT and TMS | Dimensional Anhedonia Rating Scale (DARS) | 6 months | 73.3846 score on a scale | Standard Deviation 39.7147 |
| iCBT and TMS | Dimensional Anhedonia Rating Scale (DARS) | 9 months | 81.0769 score on a scale | Standard Deviation 22.4591 |
| Psychoeducation and TMS | Dimensional Anhedonia Rating Scale (DARS) | 9 months | 116.3333 score on a scale | Standard Deviation 9.815 |
| Psychoeducation and TMS | Dimensional Anhedonia Rating Scale (DARS) | Baseline | 75 score on a scale | Standard Deviation 34.9987 |
| Psychoeducation and TMS | Dimensional Anhedonia Rating Scale (DARS) | 6 weeks | 104.1429 score on a scale | Standard Deviation 19.4545 |
| Psychoeducation and TMS | Dimensional Anhedonia Rating Scale (DARS) | 6 months | 88.25 score on a scale | Standard Deviation 59.1573 |
Primary
Hamilton Depression Rating Scale (HAM-D)
Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)
Time frame: Baseline to Post-Treatment (6 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT and TMS | Hamilton Depression Rating Scale (HAM-D) | 6 weeks | 11.3333 score on a scale | Standard Deviation 6.6297 |
| iCBT and TMS | Hamilton Depression Rating Scale (HAM-D) | Baseline | 20.4375 score on a scale | Standard Deviation 4.0983 |
| Psychoeducation and TMS | Hamilton Depression Rating Scale (HAM-D) | 6 weeks | 11.9231 score on a scale | Standard Deviation 8.7983 |
| Psychoeducation and TMS | Hamilton Depression Rating Scale (HAM-D) | Baseline | 21.7692 score on a scale | Standard Deviation 4.6035 |
Primary
Inventory of Depressive Symptomatology (IDS)
Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms)
Time frame: Baseline to Post-Treatment (6 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT and TMS | Inventory of Depressive Symptomatology (IDS) | Baseline | 42.4444 score on a scale | Standard Deviation 9.8651 |
| iCBT and TMS | Inventory of Depressive Symptomatology (IDS) | 6 weeks | 29.2222 score on a scale | Standard Deviation 15.2915 |
| Psychoeducation and TMS | Inventory of Depressive Symptomatology (IDS) | Baseline | 42.0556 score on a scale | Standard Deviation 12.0317 |
| Psychoeducation and TMS | Inventory of Depressive Symptomatology (IDS) | 6 weeks | 25.9412 score on a scale | Standard Deviation 14.2279 |
Primary
Temporal Experience of Pleasure Scale (TEPS)
Change in Depression Symptoms (Range = 0-108, higher indicates lower symptoms)
Time frame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT and TMS | Temporal Experience of Pleasure Scale (TEPS) | Baseline | 59.1875 score on a scale | Standard Deviation 8.8861 |
| iCBT and TMS | Temporal Experience of Pleasure Scale (TEPS) | 6 weeks | 61.8125 score on a scale | Standard Deviation 12.9523 |
| iCBT and TMS | Temporal Experience of Pleasure Scale (TEPS) | 6 months | 65.0833 score on a scale | Standard Deviation 13.9705 |
| iCBT and TMS | Temporal Experience of Pleasure Scale (TEPS) | 9 months | 60.8462 score on a scale | Standard Deviation 12.8572 |
| Psychoeducation and TMS | Temporal Experience of Pleasure Scale (TEPS) | 9 months | 76 score on a scale | Standard Deviation 6.5574 |
| Psychoeducation and TMS | Temporal Experience of Pleasure Scale (TEPS) | Baseline | 58.75 score on a scale | Standard Deviation 12.9483 |
| Psychoeducation and TMS | Temporal Experience of Pleasure Scale (TEPS) | 6 months | 73.3333 score on a scale | Standard Deviation 6.6583 |
| Psychoeducation and TMS | Temporal Experience of Pleasure Scale (TEPS) | 6 weeks | 73.5 score on a scale | Standard Deviation 9.6658 |