Trial results for a study investigating combined internet-based cognitive-behavioral therapy (iCBT) with Transcranial Magnetic Stimulation (TMS) in patients with Major Depressive Disorder were posted on ClinicalTrials.gov on 2025-10-29. The study enrolled 40 participants.
Background
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.
Trial design
This completed study, identified as Phase NA, enrolled 40 participants with Major Depressive Disorder. The trial compared two approaches: an intervention group receiving internet-based cognitive-behavioral therapy (iCBT) combined with Transcranial Magnetic Stimulation (TMS), and a comparator group receiving psychoeducation combined with TMS.
Key results
The trial reported several key measurements, including scores on the Hamilton Depression Rating Scale (HAM-D) and the Temporal Experience of Pleasure Scale (TEPS).
- For the Hamilton Depression Rating Scale (HAM-D):
- In the iCBT and TMS group, mean scores were 20.4375 (Standard Deviation: 4.0983) and 11.3333 (Standard Deviation: 6.6297) on a scale.
- In the Psychoeducation and TMS group, mean scores were 21.7692 (Standard Deviation: 4.6035) and 11.9231 (Standard Deviation: 8.7983) on a scale.
- For the Temporal Experience of Pleasure Scale (TEPS):
- In the iCBT and TMS group, mean scores were 59.1875 (Standard Deviation: 8.8861), 61.8125 (Standard Deviation: 12.9523), 65.0833 (Standard Deviation: 13.9705), and 60.8462 (Standard Deviation: 12.8572) on a scale.
- In the Psychoeducation and TMS group, mean scores were 58.75 (Standard Deviation: 12.9483), 73.5 (Standard Deviation: 9.6658), 73.3333 (Standard Deviation: 6.6583), and 76 (Standard Deviation: 6.5574) on a scale.
What this means
The posted results indicate that both the iCBT and TMS group and the psychoeducation and TMS group experienced reductions in Hamilton Depression Rating Scale (HAM-D) scores. For the iCBT and TMS group, the mean HAM-D score decreased from 20.4375 to 11.3333. Similarly, for the psychoeducation and TMS group, the mean HAM-D score decreased from 21.7692 to 11.9231. These findings suggest that both combined approaches may contribute to a reduction in depressive symptoms in patients with Major Depressive Disorder. The Temporal Experience of Pleasure Scale (TEPS) scores showed varied mean values across both groups, indicating different aspects of pleasure experience.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05988619, titled "iCBT With TMS in Patients With MDD", were posted on 2025-10-29 on clinicaltrials.gov.