IDEMS: Effectiveness of an online self-help program for the treatment of depressive symptoms in multiple sclerosis

Study Description:

Major depressive disorder (MDD) is a common comorbidity in multiple sclerosis (MS), is associated with lower quality of life, disease progression and higher morbidity and mortality. Despite its clinical relevance, treatment options for MS-associated depression remain limited and confirmatory trials are lacking. The aim of the current study was to evaluate the safety and effectiveness of MS-specific internet-based cognitive behavioral therapy (iCBT) program for MS-associated depressive symptoms.

We conducted an international parallel group, randomized, controlled phase III trial of an iCBT program to reduce depressive symptoms in MS. Patients with neurologist confirmed diagnosis of MS and depressive symptoms were randomized 1:1:1 (concealed allocation, no stratification, no blocking) to one of two versions of iCBT (stand alone or therapist-guided) or a control condition, in which participants received treatment as usual and were offered access to the iCBT program after 6 months. The predefined primary endpoint was severity of depressive symptoms as measured by the Beck Depression Inventory – II (BDI-II) at week 12 after randomization.

Between May 3, 2017 and November 4, 2020, n=279 participants were enrolled. Drop-out rate at week 12 was 14.7%. No occurrence of suicidality, the pre-defined safety measure, was observed during the trial. Clinically relevant worsening of depressive symptoms was observed in three participants in the control group, one in stand-alone iCBT, and none in guided iCBT.

Both versions of the iCBT program significantly reduced depressive symptoms compared to control at week 12 (primary endpoint), with effects maintained at 6 and 12 month follow up.

This trial provides evidence for safety and effectiveness of an MS-specific iCBT tool to reduce depressive symptoms.

Principal Investigator:
Prof. Dr. Stefan M. Gold, Department of Psychiatry, Charité Campus Benjamin Franklin

Registration:
ClinicalTrials.gov Identifier: NCT02740361

Course of the study:
05/2017 – 01/2021

Project partners:
Prof. Dr. Friedemann Paul (NCRC)
Prof. Dr. Christoph Heesen (Universitätsklinikum Hamburg Eppendorf)
Prof. Dr. Nancy Sicotte, MD (Cedars-Sinai Medical Center, Los Angeles)
Prof. Dr. Jared Bruce (University of Missouri, Kansas City)
Prof. Dr. Peter Arnett (Penn State University)
Prof. Dr. Rona Moss-Morris (King's College London)
Prof. Dr. Tim Friede (University Medical Center Göttingen)
Dr. Björn Meyer (GAIA Group Hamburg)

Funding:
National MS Society USA

Publications:
Gold SM, Friede T, Meyer, B, Moss-Morris, R, Hudson J, Asseyer S, Bellmann-Strobl J, Leisdon A, Ißels L, Ritter K, Schymainski D, Pomeroy H, Lynch SG, Cozart JS, Thelen J, Román CAF, Cadden M, Guty E, Lau S, Pöttgen J, Ramien C, Seddiq-Zai S, Kloidt AM, Wieditz J, Penner IK, Paul F, Sicotte NL, Bruce JM, Arnett PA, Heesen C. Internet-delivered cognitive behavioral therapy (iCBT) program to reduce depressive symptoms in multiple sclerosis: An international multicenter randomized controlled phase III trial. The Lancet Digital Health (in press)

Trial protocol: Link 

Statistical analysis plan: Link

Anonymized patient level data: Link Zenodo 10.5281/zenodo.7965979