Major Depressive DisorderNCT05988619
iCBT With TMS in Patients With MDD
A study testing Transcranial Magnetic Stimulation, Internet-Based Cognitive Behavioral Therapy and Psychoeducation in people with Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Transcranial Magnetic Stimulation, Internet-Based Cognitive Behavioral Therapy and Psychoeducation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2021to 7 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA TMS Clinical and Research Service
Los Angeles, California, 90024
About this study
Official title: Combined Internet-Based Cognitive Behavioral Therapy With Transcranial Magnetic Stimulation for Patients With Major Depressive Disorder
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Transcranial Magnetic Stimulation, Internet-Based Cognitive Behavioral Therapy, Psychoeducation
- Keywords
- Depression, TMS, Brain Stimulation, Internet-Based CBT
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called TMS
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 TherapyBehavioural
Also called iCBT, This Way Up
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.
PsychoeducationBehavioural
Also called Stories of the Mind
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Magnetic Stimulation; Behavioral: Internet-Based Cognitive Behavioral Therapy |
| 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. Receives: Device: Transcranial Magnetic Stimulation; Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D)
Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)
Measured: Baseline to Post-Treatment (6 weeks)
Temporal Experience of Pleasure Scale (TEPS)
Change in Depression Symptoms (Range = 0-108, higher indicates lower symptoms)
Measured: 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)
Measured: Baseline to Post-Treatment (6 weeks)
Dimensional Anhedonia Rating Scale (DARS)
Change in Depression Symptoms (Range = 0-130, higher indicates lower symptoms)
Measured: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start21 Mar 2021
- Primary completion7 Sep 2024
- Study completion7 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Rosenberg, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988619
- Sponsor's protocol ID
- 19000581
- Status last verified
- Sep 2025
- First submitted
- 4 Aug 2023
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Internet-Based Cognitive Behavioral Therapy With Transcranial Magnetic Stimulation for Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05988619
- Acronym / sponsor ID
- 19000581
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, TMS, Brain Stimulation, Internet-Based CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 7 Sep 2024 (actual)
- Study completion
- 7 Sep 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCBT and TMS | Active comparator | Device: Transcranial Magnetic Stimulation, Behavioral: Internet-Based Cognitive Behavioral TherapyAll 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. |
| Psychoeducation and TMS | Placebo comparator | Device: Transcranial Magnetic Stimulation, Behavioral: PsychoeducationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMSTMS 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. | Device | Psychoeducation and TMS, iCBT and TMS |
| Internet-Based Cognitive Behavioral TherapyAlso: iCBT, This Way UpThis 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. | Behavioural | iCBT and TMS |
| PsychoeducationAlso: Stories of the MindStories 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. | Behavioural | Psychoeducation and TMS |
Primary outcome
Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline to Post-Treatment (6 weeks)
Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)
Temporal Experience of Pleasure Scale (TEPS)
Time frame: 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)
Time frame: Baseline to Post-Treatment (6 weeks)
Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms)
Dimensional Anhedonia Rating Scale (DARS)
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation, Internet-Based Cognitive Behavioral Therapy and Psychoeducation in people with Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAM-D) (time frame: Baseline to Post-Treatment (6 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.