A1 Refereed original research article in a scientific journal

Effectiveness of mindfulness-based online therapy or internet-delivered cognitive behavioral therapy compared with treatment as usual among patients with persistent somatic symptoms: Protocol for a randomized controlled trial




AuthorsVangelova-Korpinen, Velina; Liira, Helena; Kurki, Samu N.; Sainio, Markku; Malmivaara, Antti; Kanerva, Mari; Stenberg, Jan-Henry; Varonen, Mikko; Venäläinen, Mikko; Vuorela, Piia; Arokoski, Jari

EditorsYu Dahua

PublisherPublic Library of Science (PLoS)

Publishing placeSAN FRANCISCO

Publication year2025

JournalPLoS ONE

Journal name in sourcePLOS ONE

Journal acronymPLOS ONE

Article numbere0316169

Volume20

Issue2

Number of pages15

ISSN1932-6203

eISSN1932-6203

DOIhttps://doi.org/10.1371/journal.pone.0316169

Web address https://doi.org/10.1371/journal.pone.0316169

Self-archived copy’s web addresshttps://research.utu.fi/converis/portal/detail/Publication/491383907


Abstract
Background

Persistent somatic symptoms unexplained by a defined medical or psychiatric condition often include a component of central sensitization. Many treatment options are based on cognitive behavioral therapy. Effective widely available therapies are scarce. There are self-management programs and e-therapies that aim at overcoming the central sensitization by modifying interoceptive neural networks in the brain.

Objectives

This study aims to investigate the effect of a mindfulness-based amygdala and insula retraining (AIR) online program and an internet delivered therapist assisted therapy offered by Helsinki University Hospital (HUS iCBTpss) compared to treatment as usual (TAU) in the treatment of conditions causing persistent somatic symptoms.

Methods

We will perform a randomized controlled trial aiming at 360 patients. Consenting patients will be randomized to three study arms: online AIR program, HUS iCBTpss (both interventions as add-ons to TAU); and TAU. Functional ability and quality of life surveys will be collected from participants at baseline and at 3, 6, and 12 months after entering the study.

Conclusions

This study is one of the first to explore non-drug based online interventions developed to overcome the brain’s central sensitization and are available and accessible to patients both in primary and secondary care. The results will develop the management of the common, often debilitating persistent somatic symptoms related to many conditions unexplained by a defined somatic or psychiatric illness.


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Funding information in the publication
European Union's Horizon Europe research and innovation programme


Last updated on 2025-07-04 at 12:13