Trial Outcomes & Findings for iCBT With TMS in Patients With MDD (NCT NCT05988619)
NCT ID: NCT05988619
Last Updated: 2025-10-29
Results Overview
Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline to Post-Treatment (6 weeks)
Results posted on
2025-10-29
Participant Flow
100 individuals were recruited and screened
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)
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
15
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
13
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
9
|
Baseline Characteristics
iCBT With TMS in Patients With MDD
Baseline characteristics by cohort
| Measure |
iCBT and TMS
n=18 Participants
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.
|
Psychoeducation and TMS
n=18 Participants
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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Post-Treatment (6 weeks)Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)
Outcome measures
| Measure |
iCBT and TMS
n=18 Participants
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.
|
Psychoeducation and TMS
n=18 Participants
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.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D)
Baseline
|
20.4375 score on a scale
Standard Deviation 4.0983
|
21.7692 score on a scale
Standard Deviation 4.6035
|
|
Hamilton Depression Rating Scale (HAM-D)
6 weeks
|
11.3333 score on a scale
Standard Deviation 6.6297
|
11.9231 score on a scale
Standard Deviation 8.7983
|
PRIMARY outcome
Timeframe: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-upChange in Depression Symptoms (Range = 0-108, higher indicates lower symptoms)
Outcome measures
| Measure |
iCBT and TMS
n=18 Participants
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.
|
Psychoeducation and TMS
n=18 Participants
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.
|
|---|---|---|
|
Temporal Experience of Pleasure Scale (TEPS)
Baseline
|
59.1875 score on a scale
Standard Deviation 8.8861
|
58.75 score on a scale
Standard Deviation 12.9483
|
|
Temporal Experience of Pleasure Scale (TEPS)
6 weeks
|
61.8125 score on a scale
Standard Deviation 12.9523
|
73.5 score on a scale
Standard Deviation 9.6658
|
|
Temporal Experience of Pleasure Scale (TEPS)
6 months
|
65.0833 score on a scale
Standard Deviation 13.9705
|
73.3333 score on a scale
Standard Deviation 6.6583
|
|
Temporal Experience of Pleasure Scale (TEPS)
9 months
|
60.8462 score on a scale
Standard Deviation 12.8572
|
76 score on a scale
Standard Deviation 6.5574
|
PRIMARY outcome
Timeframe: Baseline to Post-Treatment (6 weeks)Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms)
Outcome measures
| Measure |
iCBT and TMS
n=18 Participants
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.
|
Psychoeducation and TMS
n=18 Participants
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.
|
|---|---|---|
|
Inventory of Depressive Symptomatology (IDS)
Baseline
|
42.4444 score on a scale
Standard Deviation 9.8651
|
42.0556 score on a scale
Standard Deviation 12.0317
|
|
Inventory of Depressive Symptomatology (IDS)
6 weeks
|
29.2222 score on a scale
Standard Deviation 15.2915
|
25.9412 score on a scale
Standard Deviation 14.2279
|
PRIMARY outcome
Timeframe: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-upChange in Depression Symptoms (Range = 0-130, higher indicates lower symptoms)
Outcome measures
| Measure |
iCBT and TMS
n=18 Participants
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.
|
Psychoeducation and TMS
n=18 Participants
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.
|
|---|---|---|
|
Dimensional Anhedonia Rating Scale (DARS)
6 weeks
|
90.2667 score on a scale
Standard Deviation 25.401
|
104.1429 score on a scale
Standard Deviation 19.4545
|
|
Dimensional Anhedonia Rating Scale (DARS)
6 months
|
73.3846 score on a scale
Standard Deviation 39.7147
|
88.25 score on a scale
Standard Deviation 59.1573
|
|
Dimensional Anhedonia Rating Scale (DARS)
Baseline
|
78.125 score on a scale
Standard Deviation 15.5258
|
75 score on a scale
Standard Deviation 34.9987
|
|
Dimensional Anhedonia Rating Scale (DARS)
9 months
|
81.0769 score on a scale
Standard Deviation 22.4591
|
116.3333 score on a scale
Standard Deviation 9.815
|
Adverse Events
iCBT and TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychoeducation and TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place