Evidence map›Paper›PMID 31640632›Full record

ArticleBMC psychiatry2019

Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.

Trudie Chalder, Meenal Patel, Kirsty James, Matthew Hotopf, Philipp Frank, Katie Watts, Paul McCrone, Anthony David, Mark Ashworth, Mujtaba Husain and 3 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02426788 (The PRINCE Secondary Study), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.0field-weighted citation impact, top 9% 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.

NCT02426788 nacompletednot on this map

The PRINCE Secondary Study: Persistent Physical Symptoms Reduction Intervention: a System Change and Evaluation in Secondary Care

TypeinterventionalSponsorKing's College LondonRan2015 to 2019Enrolled324ConditionsPersistent Physical Symptoms (PPS)ArmsCognitive behavioural therapy (CBT)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Family narratives of lives with persistent physical symptom conditions.Clinical child psychology and psychiatry · 2021
    Article
  8. Identifying and managing functional cardiac symptoms.Clinical medicine (London, England) · 2021
    Article
  9. Medically unexplained symptoms: assessment and management.Clinical medicine (London, England) · 2021
    Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Trudie ChalderDepartment of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.
Meenal PatelDepartment of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.
Kirsty JamesDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Matthew HotopfDepartment of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.
Philipp FrankDepartment of Behavioural Science and Health, University College London, London, UK.
Katie WattsDepartment of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.
Paul McCroneHealth Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Anthony DavidDivision of Psychiatry, University College London, London, UK.
Mark AshworthPopulation Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Mujtaba HusainSouth London and Maudsley NHS Foundation Trust, London, UK.
Toby GarroodDepartment of Rheumatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Rona Moss-MorrisSchool of Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Sabine LandauDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
King's College London · GBUniversity College London · GBGuy's and St Thomas' NHS Foundation Trust · GBSouth London and Maudsley NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPersistent physical symptoms (PPS), also known as medically unexplained symptoms (MUS), affect approximately 50% of patients in secondary care and are often associated with disability, psychological distress and increased health care costs. Cognitive behavioural therapy (CBT) has demonstrated both short- and long-term efficacy with small to medium effect sizes for PPS, with larger treatment effects for specific PPS syndromes, including non-cardiac chest pain, irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS). Research indicates that PPS conditions share similar cognitive and behavioural responses to symptoms, such as avoidance and unhelpful beliefs. This suggests that a transdiagnostic approach may be beneficial for patients with PPS.

methodsA randomised controlled trial (RCT) will be conducted to evaluate the efficacy and cost-effectiveness of a transdiagnostic CBT-based intervention for PPS. 322 participants with PPS will be recruited from secondary care clinics. Participants stratified by clinic and disability level will be randomised to CBT plus standard medical care (SMC) versus SMC alone. The intervention consists of 8 CBT sessions delivered by a qualified therapist over a period of 20 weeks. Outcomes will be assessed at 9, 20, 40- and 52-weeks post randomisation. Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation. Secondary outcomes will include mood, symptom severity and clinical global impression at 9, 20, 40 and 52 weeks. Cost-effectiveness will be evaluated by combining measures of health service use, informal care, loss of working hours and financial benefits at 52 weeks. DISCUSSION: This trial will provide a powered evaluation of the efficacy and cost-effectiveness of a transdiagnostic CBT approach versus SMC for patients with PPS. It will also provide valuable information about potential healthcare pathways for patients with PPS within the National Health Service (NHS).

trial registrationClinicalTrials.gov NCT02426788. Registered 27 April 2015. Overall trial status: Ongoing; Recruitment status: No longer recruiting.

Indexed as

AdultCognitive Behavioral TherapyCost-Benefit AnalysisFemaleHumansMaleRandomized Controlled Trials as TopicSecondary Health CareSomatoform DisordersState MedicineTreatment OutcomeCognitive behavioural therapy (CBT)Medically unexplained symptomsRandomised controlled trial (RCT)Secondary care

Identifiers

PMID31640632
PMCPMC6805658
OpenAlexW2982115386

What OpenQuestion holds

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LicenceCC BY
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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.