CBT Plus SMC Compared to SMC for Persistent Physical Symptoms in Secondary Care (PRINCE)
Condition: Persistent Physical Symptoms (PPS)
MeSH terms: Neoplasm Metastasis
Study type: Interventional

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).
    

Detailed description: 
      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
    

Intervention name(s): Cognitive behavioural therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): Behavioral: Cognitive behavioural therapy (CBT) The CBT intervention used in the trial has been adapted for people with PPS and it is based on a model of understanding PPS (Deary et al 2007). 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 quality of life. The approach is transdiagnostic in that it targets processes and underlying mechanisms that affect disorders similarly, rather than focusing on how they are diagnostically different. The approach is personalised during therapy following a detailed assessment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: medically unexplained; fibromyalgia; postural orthostatic tachycardia syndrome (PoTs); non-cardiac chest pain; CFS; irritable bowel syndrome (IBS); functional neurological; chronic pain; hyperventilation; unexplained cough