Persistent Physical Symptoms (PPS) Clinical Trial
Official title:
The PRINCE Secondary Study: Persistent Physical Symptoms Reduction Intervention: a System Change and Evaluation in Secondary Care
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).
Background and study aims In primary care between 20 and 40% of patients have medically
unexplained physical symptoms. The term medically unexplained symptoms (MUS) is commonly used
by health care professionals. However a survey of a healthy population and a separate survey
of patients with chronic fatigue syndrome (CFS) suggested that the term persistent physical
symptoms (PPS) was the preferred term. The term PPS may have its drawbacks, but it will be
used in the rest of this document to cover MUS as well as any other terms that may be used in
the literature and clinical settings to refer to these symptoms. In secondary care, about 50%
of patients have PPS, in many specialties. PPS are associated with profound disability and
high health care costs. Around 50% of sufferers have co-morbid anxiety and depression and
sleep problems. Left untreated, the prognosis of these patients is poor.
This study is a pragmatic RCT that will evaluate the clinical and cost-effectiveness of
cognitive behavioural therapy + standard medical care (CBT+SMC), which involves 8 sessions of
CBT, versus standard medical care (SMC) in the treatment of patients with PPS.
Who can participate? Patients with various PPS, such as fibromyalgia, non-cardiac chest pain,
irritable bowel syndrome and a range of neurological symptoms e.g., weakness will be
recruited. Participants will be recruited from clinics in secondary care (e.g., neurology,
cardiology, rheumatology) at various hospitals in London.
What does the study involve? Potential participants will be identified by clinical staff who
will refer them to the research team. Patients who give their consent to take part in the
study will complete a number of questionnaires asking about their symptoms and use of health
care services, and about their thoughts, feelings, and beliefs related to their PPS (i.e.,
baseline). This will take approximately 1.5 hours. After this research assessment, half of
participants will be randomly assigned to the treatment arm (CBT+SMC), or to the control
(SMC) arm. Participants in the treatment arm will receive 8 individual sessions of CBT
(weekly or fortnightly sessions). The therapy aims to help the patient develop an
understanding of the relationship between cognitive, physiological and behavioural aspects of
their problem; to understand factors that may be maintaining the problem and to learn how to
modify their behavioural and cognitive responses in order to improve their quality of life.
Participants in the SMC group will receive usual medical care within the clinic.
Participants in both arms will also be asked to complete questionnaires at 9, 20, 40, and 52
weeks after randomisation. The assessment will be independent of the health care
professionals delivering care.
What are the possible benefits and risks of participating? By taking part in the study
patients may get helpful information about their condition. If assigned to the CBT+SMC arm,
patients will receive 8 sessions of CBT focused on helping them manage their symptoms, which
may improve their symptoms and increase their psychosocial functioning. It is unclear whether
CBT for patients with PPS is effective; this trial will assess whether there are benefits to
receiving it. Patients may benefit from being followed up closely and completing measures. It
is not expected that participation in the study is associated with risks. The therapists
involved in the trial are highly qualified specialists with extensive experience in treating
patients with PPS. The trial team also includes a psychiatrist who will further ensure
patient safety in complex cases. Participants will be free to take a break at any point
during the meetings and are free to withdraw from the study at any point. Participants will
also be informed that they can raise any concerns they may have with the research team and
will be provided with the Patient Advice & Liaison Service contact information.
Where is the study run from? The study has been set up by the Institute of Psychiatry,
Psychology and Neuroscience (IoPPN) at King's College London and the South London and
Maudsley National Health Service (NHS) Foundation Trust, and will be conducted at several
hospitals in London/Greater London, including Guy's and St Thomas' Hospitals, King's College
Hospital, Princess Royal University Hospital, Royal Free Hospital, University Hospital
Lewisham and Queen Elizabeth Hospital.
When is the study starting and how long is it expected to run for? The study has started in
July 2015 and the end date for the project is March 2019.
Who is funding the study? The study is funded by the Guy's and St. Thomas' Charity.
Who is the main contact? Prof Trudie Chalder trudie.chalder@kcl.ac.uk
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