JMIR Publications

ABSTRACT

Background:

In recent years, repetitive Transcranial Magnetic Stimulation (rTMS) has become a first-line recommendation in the Netherlands for individuals with Major Depressive Disorder (MDD) who have not responded to a minimum of two prior treatments. Although rTMS can be effective, a significant risk of relapse exists after treatment. Currently, there are no standardized treatment options available post rTMS treatment completion aimed at preventing relapse. Preventive Cognitive Therapy (PCT) is a brief psychological intervention designed to prevent relapse in partially and fully remitted individuals of MDD.

Objective:

This study aims to establish feasibility of adding PCT after intensive rTMS treatment for responding patients.

Methods:

This pilot randomized controlled trial aims to investigate the feasibility of adding PCT following rTMS treatment for depression, either online or face-to-face. Participants who demonstrate partial or full response to rTMS, defined as at least 25% reduction in symptoms as quantified by the Inventory of Depressive Symptomatology - Self Rated (IDS-SR) or with IDS-SR score of 22 or lower will be included. Twenty participants will be randomly allocated to either face-to-face or online PCT treatment and treatment adherence between face to face or online treatment will be compared. Secondary, changes in affective states assessed through experience sampling data during PCT will be studied to establish usefulness for a larger RCT aimed on the effectiveness of PCT after rTMS. Lasty, possible relapse of MDD will be monitored throughout the intervention and follow-up period.

Results:

This study was reviewed and approved according to the Medical Research Involving Human Subjects Act (WMO; ‘Wet Medisch-Wetenschappelijk Onderzoek met Mensen’) by the Medical Research Ethics Committee of the Amsterdam UMC on 17th of June 2024 (trial register: NL85703.018.23). As of September 2025, participant recruitment has ended after 11 included participants. We expect data analysis and expected results to be published in fall 2026.

Conclusions:

If this pilot study shows feasibility of adding PCT following rTMS treatment for depression either online of face-to-face, a larger-scale randomized controlled clinical trial may be performed to study the effects of PCT on remission durations, relapse rates and affective states in remitted MDD individuals after rTMS treatment. This pilot will provide insight into feasibility of face-to-face or online PCT treatment after successful rTMS treatment in depression. Clinical Trial: This trial has been registered in the Dutch national trial registry (Trial number: NL85703.018.23)