Patient-reported outcomes following accelerated vs. standard TMS with the H1 coil for major depression: A multisite randomized trial.

OBJECTIVE

Clinician-rated measures remain the gold standard in depression trials, but patient-reported outcomes (PROs) provide essential insights into real-world experiences. This study compared PROs in patients with Major Depressive Disorder (MDD) receiving either accelerated H1-coil Transcranial Magnetic Stimulation (ACC-iTBS) or standard once-daily high-frequency H1-coil TMS (SOC-HF).

METHODS

In this randomized, multisite trial, 104 adults with moderate-to-severe MDD were assigned to ACC-iTBS (five sessions/day for six days, 50min intersession-interval, 50 Hz triplets, 5 Hz bursts frequency, 2s on, 8s off, 1800 pulses/session) or SOC-HF (daily sessions for four weeks, 18 Hz, 2s on 20s off, 1980 pulses/session), each followed by continuation treatment through week 6. PROs included the daily Clinically Useful Depression Outcome Scale (CUDOS-D), Clinically Useful Anxiety Outcome Scale (CUXOS-D), and the Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Outcomes assessed were response/remission rates, time to perceived improvement, and quality-of-life changes.

RESULTS

Both protocols produced significant and comparable improvements in depressive symptoms, anxiety, and quality-of-life. Week 6 CUDOS response/remission rates were 70.0%/57.5% (ACC-iTBS) and 75.6%/58.5% (SOC-HF); CUXOS rates were 70.0%/67.5% (ACC-iTBS) and 75.6%/69.0% (SOC-HF). Patients in the ACC-iTBS arm reported a shorter median time to CUDOS response (11 vs. 16 days, p = 0.0377). Anxiety improvements emerged early and were sustained across both groups. By week 6, severe quality-of-life impairment declined to 15-17%, compared with 85-100% at baseline. No significant between-group differences were observed.

CONCLUSIONS

Accelerated TMS with the H1 coil provides patient-perceived benefits comparable to standard treatment while delivering faster relief of depressive symptoms. ACC-iTBS may represent a time-efficient, patient-centered alternative that improves accessibility and satisfaction for individuals with MDD.