Comparing the Feasibility of In-Person and Online Preventive Cognitive Therapy for Major Depressive Disorder After Partial Response to Repetitive Transcranial Magnetic Stimulation: Protocol for a Pilot Randomized Controlled Trial.

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 2 prior treatments. Although rTMS can be effective, there is a significant risk of relapse after treatment. Currently, there are no standardized treatment options available after 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 with MDD.

Objective: This study aims to establish the feasibility of 2 distinct forms of PCT (online and face-to-face) after intensive rTMS treatment for responding patients.

Methods: Participants who demonstrate partial or full response to rTMS, defined as at least 25% reduction in symptoms, as quantified using the Inventory of Depressive Symptomatology-Self-Report (IDS-SR) or an IDS-SR score of 22 or lower will be included. Twenty participants will be randomly allocated to either face-to-face or online PCT, and treatment adherence will be compared between face-to-face and online treatment. The study will be deemed feasible if at least 75% of participants complete PCT during the grant duration of 1.5 years. For PCT, we aim to see which delivery format is the most feasible. Secondarily, changes in affective states, assessed through experience sampling data during PCT, will be studied to establish usefulness for a larger randomized controlled trial aimed at evaluating the effectiveness of PCT after rTMS. Finally, possible MDD relapse will be monitored throughout the intervention and follow-up periods.

Results: This study was funded in November 2023 by the Netherlands Organisation for Health Research and Development. It was reviewed and approved according to the Medical Research Involving Human Subjects Act (Wet Medisch-Wetenschappelijk Onderzoek met Mensen) by the Medical Research Ethics Committee of Amsterdam University Medical Center on June 17, 2024. Data collection started in August 2024 and ended in April 2026, with an inclusion of 11 participants. As of June 2026, data analysis has not yet started. We expect data analysis and manuscript preparation of results to be completed in December 2026.

Conclusions: If this pilot study shows preferred feasibility of a specific format of PCT (either online or face-to-face) following rTMS treatment for depression, a larger-scale randomized controlled clinical trial may be performed to study the effects of PCT on remission duration, relapse rates, and affective states in remitted individuals with MDD after rTMS treatment using this preferred delivery format. This pilot will provide insights into the feasibility of face-to-face or online PCT after successful rTMS treatment in depression.