Evidence map›Paper›PMID 31818310›Full record

ArticleTrials2019

Psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms, the CORPUS trial: study protocol for a randomised controlled trial.

Margreet S H Wortman, Johannes C van der Wouden, Janneke P C Grutters, Bart Visser, Willem J J Assendelft, Henriëtte E van der Horst, Tim C Olde Hartman

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Symptoms in family practice: New findings using electronic medical record data.Canadian family physician Medecin de famille canadien · 2021
    Article
  4. Canadian family physician Medecin de famille canadien · 2021
    Article
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

7 authors.

Margreet S H WortmanACHIEVE - Centre of Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands. m.s.h.wortman@hva.nl.ORCID http://orcid.org/0000-0002-4799-3041
Johannes C van der WoudenDepartment of General Practice and Elderly Care Medicine, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.
Janneke P C GruttersDepartment for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.
Bart VisserACHIEVE - Centre of Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.
Willem J J AssendelftDepartment of Primary and Community Care, Radboud University Medical Center, Nijmegen, The Netherlands.
Henriëtte E van der HorstDepartment of General Practice and Elderly Care Medicine, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.
Tim C Olde HartmanDepartment of Primary and Community Care, Radboud University Medical Center, Nijmegen, The Netherlands.

Funding

Nederlandse Organisatie voor Wetenschappelijk Onderzoek 023.008.010Stichting Stoffels Hornstra (NL) NAZonMw 843001802
6 · The paper itself

Abstract

backgroundMedically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient's acceptability, feasibility and effects on symptoms. The aim of this study is to establish whether psychosomatic therapy by specialised psychosomatic exercise therapists is cost- effective in decreasing symptoms and improving functioning in patients who frequently consult their general practitioner (GP) with MUS.

methodsA randomised effectiveness trial with an economic evaluation in primary care with 158 patients aged 18 years and older who are frequently consulting their GP with MUS. Patients will be assigned to psychosomatic therapy in addition to usual care or usual care only. Psychosomatic therapy is a multi-component and tailored intervention, aiming to empower patients by applying psycho-education, relaxation techniques, mindfulness, cognitive approaches and/or graded activity. Patients assigned to the psychosomatic therapy receive 6 to 12 sessions of psychosomatic therapy, of 30-45 min each, delivered by a specialised exercise or physical therapist. Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months. An economic evaluation alongside the trial will be conducted from a societal perspective, with quality-adjusted life years (QALYs) as outcome measure. Furthermore, a mixed-methods process evaluation will be conducted. DISCUSSION: We expect that psychosomatic therapy in primary care for patients who frequently attend the GP for MUS will improve symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care. We expect that the psychosomatic therapy provides value for money for patients with MUS.

trial registrationNetherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.

Indexed as

Cognitive Behavioral TherapyMedically Unexplained SymptomsMindfulnessRandomized Controlled Trials as TopicRelaxation TherapyAdolescentAdultAgedAged, 80 and overCost-Benefit AnalysisHumansMiddle AgedOutcome Assessment, Health CarePrimary Health CareYoung AdultCost-effectivenessMedically unexplained symptomsPrimary carePsychosomatic therapyRandomised controlled trialStudy protocol

Identifiers

PMID31818310
PMCPMC6902505

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Registered trials

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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.