Evidence map›Paper›PMID 33762239›Full record

ArticleBMJ open2021

Helpful explanatory models for somatoform symptoms (HERMES): study protocol of a randomised mixed-methods pilot trial.

Paul Hüsing, Bernd Löwe, Tim C Olde Hartman, Lisbeth Frostholm, Angelika Weigel

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 36% of its field
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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. 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

5 authors at 3 institutions in 4 countries.

Paul HüsingDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany p.huesing@uke.de.ORCID http://orcid.org/0000-0002-6235-2699
Bernd LöweDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Tim C Olde HartmanDepartment of Primary and Community Care, Radboud University Medical Center, Nijmegen, The Netherlands.
Lisbeth FrostholmResearch Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark.
Angelika WeigelDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Universität Hamburg · DEAarhus University Hospital · DKRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPersistent somatic symptoms (PSS) are common both in the general population and primary care. They are bothersome in terms of psychological and somatic symptom burden. Health professionals often struggle with communication, as there is a lack of scientifically supported explanatory models for PSS or a focus merely on somatic aspects of the complaints, which both frustrate patients' needs. The objective of the present study is therefore to develop a psychoeducational intervention based on a current evidence-based explanatory model, to examine its feasibility and form the basis for a large-scale randomised controlled trial. METHODS AND ANALYSIS: In a randomised controlled mixed-methods pilot trial, 75 adult psychosomatic outpatients with PSS (duration of symptoms ≥6 months) and accompanying psychological (Somatic Symptom B-Criteria Scale total score ≥18) and somatic symptom burden (Patient Health Questionnaire-15 score >10) and no prior psychosomatic treatment will be eligible. Participants will be presented with either the explanatory model without (intervention group 1, n=25) or with elements of personalisation (intervention group 2, n=25). Participants in the control group (n=25) will receive information on current PSS guidelines. Participants will be blinded to group assignment and interventions will be shown on tablet computers at the outpatient clinic. After 1 month, qualitative follow-up telephone interviews will be conducted. As primary outcomes, mean changes in psychological and somatic symptom burden will quantitatively be compared between groups, respectively. Behavioural change mechanisms and feasibility of the three interventions will be evaluated using quantitative and qualitative measures. ETHICS AND DISSEMINATION: Ethics approval has been granted by the medical ethics board of the Hamburg Medical Chamber (PV5653). Results from this study will be published in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: DRKS00018803.

Indexed as

Medically Unexplained SymptomsAdultHumansPilot ProjectsPrimary Health CareRandomized Controlled Trials as Topicgeneral medicine (see internal medicine)preventive medicineprimary carepsychiatry

Identifiers

PMID33762239
PMCPMC7993177
OpenAlexW3137070215

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.