Evidence map›Paper›PMID 39937805›Full record

ArticlePloS one2025

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.

Velina Vangelova-Korpinen, Helena Liira, Samu N Kurki, Markku Sainio, Antti Malmivaara, Mari Kanerva, Jan-Henry Stenberg, Mikko Varonen, Mikko Venäläinen, Piia Vuorela and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05212467 (Amygdala and Insula Retraining), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05212467 naunknown statusnot on this map

Amygdala and Insula Retraining (AIR) Program and HUS Internet Therapy Compared to Treatment as Usual in Bodily Stress Syndrome, Fibromyalgia, Post Covid-19, and Chronic Fatigue Syndrome (ME/CFS)

TypeinterventionalSponsorHelsinki University Central HospitalRan2022 to 2024Enrolled360ConditionsFunctional Disorders, Post Covid-19ArmsAIR-program, HUS Internet therapy, Treatment as usual
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Velina Vangelova-KorpinenOutpatient Clinic for Persistent Symptom Rehabilitation, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.ORCID 0009-0002-1197-0216
Helena LiiraOutpatient Clinic for Persistent Symptom Rehabilitation, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Samu N KurkiFaculty of Biological and Environmental Sciences, Molecular and Integrative Biosciences, University of Helsinki, Helsinki, Finland.ORCID 0000-0002-7531-0957
Markku SainioOutpatient Clinic for Persistent Symptom Rehabilitation, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Antti MalmivaaraFinnish Institute for Health and Welfare, Helsinki, Finland.
Mari KanervaOutpatient Clinic for Persistent Symptom Rehabilitation, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.ORCID 0000-0002-1993-2532
Jan-Henry StenbergDepartment of Psychiatry, Brain Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Mikko VaronenOutpatient Clinic for Persistent Symptom Rehabilitation, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Mikko VenäläinenDepartment of Medical Physics, Turku University Hospital, Turku, Finland.
Piia VuorelaFinnish Medicines Agency Fimea, Helsinki, Finland.
Jari ArokoskiDivision of Rehabilitation, Department of Internal Medicine and Rehabilitation, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPersistent 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.

objectivesThis 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.

methodsWe 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.

conclusionsThis 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. TRIAL REGISTRATION NUMBER: NCT05212467.

Indexed as

Cognitive Behavioral TherapyMedically Unexplained SymptomsMindfulnessAdultFemaleHumansInternetInternet-Based InterventionMaleMiddle AgedQuality of LifeRandomized Controlled Trials as TopicTreatment Outcome

Identifiers

PMID39937805
PMCPMC11819597

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.