Protocol: Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE), 2015 onwards, Chalder, Moss-Morris, et al

Sly Saint

Sly Saint

Senior Member (Voting Rights)
(Not sure exactly what these are, but results are due I think?)

PRINCE Primary: Integrated GP Care for Persistent Physical Symptoms - a Feasibility & Cluster Randomised Controlled Trial (PRINCE Primary)

Sponsor:
King's College London
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London
Detailed Description:


Patients with PPS are often severely functionally impaired and. They consume large amounts of healthcare and welfare benefits. There is an accumulating body of evidence showing that cognitive behavioural interventions can reduce levels of symptoms and improve overall functioning in patients with PPS. CBT has demonstrated both short-term and long-term efficacy with small to medium effect sizes for PPS. Larger treatment effects have been reported for specific PPS syndromes, including non-cardiac chest pain, Irritable Bowel Syndrome (IBS), and Chronic Fatigue Syndrome (CFS).

General practitioners (GPs) play a major role in identifying and managing patients with PPS. A previous randomised parallel group pilot trial investigated the feasibility (i.e. recruitment, retention and acceptability) of implementing a primary care Symptoms Clinic for patients with PPS). The Symptoms Clinic comprised a structured set of consultations delivered by a specially trained GP with a strong interest in PPS. The intervention included exploring potential biological mechanisms underlying the PPS condition, empathetic support, and training patients in symptom-management (i.e. medication or cognitive behavioural techniques). The results indicated that the Symptoms Clinic was acceptable to the majority of patients randomised to the intervention group, and may have the potential to generate clinically significant benefits. However, this pilot study did not assess feasibility parameters referring to GPs' willingness to participate in the study and undergo specialised psychological training. Moreover, the intervention was carried out by only one GP, raising questions about the generalizability of the study.

Managing patients with PPS can be highly challenging in general practice. Although GPs recognise the treatment of PPS as a responsibility of primary care, previous studies show that GPs often feel powerless, frustrated and helpless when encountering these patients. Furthermore, GPs frequently report that factors such as time constraints and the lack of psychological training prevents them from effectively addressing patients' psychosocial needs and developing appropriate doctor-patient communication skills.

The aim of this study is to assess whether it is feasible to conduct an adequately powered future trial to evaluate the efficacy and cost-effectiveness of a CBT-based integrated GP care approach for treating patients with PPS (please refer to arms and interventions for more details).
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https://clinicaltrials.gov/ct2/show/NCT02444520

The PRINCE Secondary Study: Persistent Physical Symptoms Reduction Intervention: a System Change and Evaluation in Secondary Care
Brief Summary:
Brief Summary: Persistent Physical Symptoms (PPS), also known as medically unexplained symptoms (MUS) is a term used to describe a range of persistent bodily symptoms for which the exact cause is unclear.
Between 20 and 40% of patients in primary care, and about 50% in secondary care experience PPS. Not only are PPS common, but the overlap across different patient groups may indicate that these phenomena are transdiagnostic.

PPS are associated with profound disability and high health care costs, and if left untreated the prognosis of these patients is poor. There is an accumulating body of evidence demonstrating that cognitive behavioural interventions can reduce levels of symptoms and improve functioning in patients with PPS.

A pragmatic randomised controlled trial (RCT) was designed to evaluate the clinical and cost-effectiveness of cognitive behavioural therapy (CBT) + Standard Medical Care (SMC) versus Standard Medical Care alone, in the treatment of patients with PPS. The trial will focus on patients with a variety of symptoms (e.g., non-cardiac chest pain, fibromyalgia), across secondary care clinics (e.g., neurology, cardiology, and rheumatology).
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Study Design
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The PRINCE Secondary Study: Persistent Physical Symptoms Reduction Intervention: a System Change and Evaluation in Secondary Care
Study Start Date : July 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018
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https://clinicaltrials.gov/ct2/show/NCT02426788


(see also page 20 of this document:
https://kcl-mrcdtp.com/wp-content/u...2-Project-Catalogue-201718-Updated-June18.pdf
17.2 Understanding transtherapeutic mechanisms in cognitive behavioral interventions for patients with Persistent Physical Symptoms
Co-Supervisor 1A: Prof Sabine Landau
Research School/Division or CAG: Psychology and Systems Sciences
Email: sabine.landau@kcl.ac.uk
Website: https://kclpure.kcl.ac.uk/portal/sabine.landau.html

Co-Supervisor 1B: Prof Trudie Chalder
Research School/Division or CAG: Psychological Medicine
Email: trudie.chalder@kcl.ac.uk
Website: https://kclpure.kcl.ac.uk/portal/trudie.chalder.html

Project description:
Chronic Fatigue Syndrome (CFS) and Irritable Bowel Syndrome are examples of disorders characterised by Persistent Physical Symptoms (PPS), which are associated with profound disability and high health care costs. There is an accumulating body of evidence demonstrating that cognitive behavioural interventions can reduce levels of symptoms and improve functioning.

While it is standard clinical practice to adapt psychological therapies to the patient population it is not clear which components of the cognitive and behavioural intervention are transtherapeutic, that is, address needs shared by patients across the PPS spectrum, and which are disorder specific.

Identifying such mechanisms can help clinicians target core mechanisms and develop new psychological interventions for other patient groups with PPS.

This PhD project will develop and apply methods for modelling the impact of disorder on underlying mechanisms and will provide an opportunity to develop knowledge of psychological theory and interventions and skills in biostatistics. In year one, the student will carry out a systematic review of mechanistic theories in PPS and existing methods for assessing transtherapeutic mechanisms and will prepare individual participant data (IPD) from a number of CBT trials for pooling; likely to include the PACE and PRINCE Secondary trials in CFS and other PPS populations.

A number of putative mediators and effect modifiers have been measured across trials. This project will develop modelling techniques to assess whether mechanisms are shared across disorders or operate differentially. We envisage structural equation modelling and IPD meta-analysis/integrative data analysis techniques to play an important role in this methodological project (years 2 and 3).

Two representative publications from supervisors:
Dunn G., Emsley E., Liu H., Landau S., Green J., White I. & Pickles A. (2015) Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme. Health Technology Assessment 19 (93) http://dx.doi.org/10.3310/hta19930
Chalder T., Goldsmith KA, White PD, Sharpe M, Pickles AR. (2015) Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial. Lancet Psychiatry 2 (2):141-52. doi.org/10.1016/S2215-0366(14)00069-8
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Has there ever been a solution more desperately in search of a problem? I guess they kind of solved that problem by just inventing a fictional representation of the problem but still it's pathological at this point.

CBT will make your car go faster.

CBT will make the sun shine brighter.

CBT will dissolve calcium deposits in your drain.

Ironically this is the biggest tell of all about snake oil: claiming that it basically works for everything. Nothing does. It's not a thing.
 
Trish said:
CBT trains you to fill in questionnaires differently.
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That's the most depressing thing of all. "Fatigue was reduced". No, no it wasn't, you can't know or verify that. This whole body of research literally makes a point of pretending to help people whose health problems (I'm sorry... health "complaints") cannot be tested for. It shouldn't even be allowed to make definitive statements like this, especially when the premise is "these people can't actually be sick since we can't test for it". Nevermind that it's a secondary symptom and that the participants may or may not have ME...

Then again, the whole premise of PACE is that our judgment is flawed yet it relies on our judgment as evidence that it worked, the very same judgment that has been opinionated to be flawed, something which can't be tested for either. We can't test (yet) this particular diagnosis so clearly they have this other diagnosis which is impossible to test for either but just trust us over this will ya, and don't listen to the people doing this "biomedical research" thing, they're clearly biased with their machines and numbers and whatnot.

Catch-22 disease, I tell ya.
 
While it is standard clinical practice to adapt psychological therapies to the patient population it is not clear which components of the cognitive and behavioural intervention are transtherapeutic, that is, address needs shared by patients across the PPS spectrum, and which are disorder specific.

Identifying such mechanisms can help clinicians target core mechanisms and develop new psychological interventions for other patient groups with PPS.
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The clear presumption is that core mechanisms are psychological. So no risk of any bias creeping in there then :rolleyes:.
 
Jonathan Edwards said:
As we have been told on another thread these 40% of cases do not actually have a medical condition. They need to play chess.
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Unfortunately I'm proof of this. I have been playing online chess obsessively since last April (as a way to pass the time and keep my spirits up since all my other hobbies have had to be cancelled). In that time my health has improved. So I obviously didn't have a medical condition and chess has done the trick. I still can't shovel snow, but let's not complicate things.
 
Jonathan Edwards said:
As we have been told on another thread these 40% of cases do not actually have a medical condition. They need to play chess. Psychotherapists are much too expensive these days.
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In the words of Matt Hancock: Secretary of State for Health and Social Care Matt Hancock said: “Personalised care is the future and there’s growing evidence that supporting people to access community services and activities, such as chess clubs or dance classes, has the power to improve people’s health and wellbeing. For the first time ever, millions of people across the country will soon be able to access care that is truly tailored to their individual needs."

Link at: https://www.england.nhs.uk/2019/01/army-of-workers-to-support-family-doctors/

Summary Plain English version available at: https://www.networks.nhs.uk/editors-blog/in-the-consulting-room-social-prescribing
 
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