PRINCE Secondary (version 1)

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    156145

  • Contact name

    Trudie Chalder

  • Contact email

    trudie.chalder@kcl.ac.uk

  • Duration of Study in the UK

    2 years, 8 months, 30 days

  • Research summary

    Pragmatic randomised controlled trial to evaluate the clinical and cost-effectiveness of a secondary care-based intervention which includes: (1) a joint clinic (JC) by an acute care specialist (e.g., neurologist / cardiologist / rheumatologist consultant/registrar/nurse) and a therapist (e.g., clinical psychologist / CBT therapist), but including cognitive behavioural components (CBT) (for which there is preliminary evidence of efficacy), and (2) up to 8 sessions of cognitive behavioural therapy (CBT) (minimum 4). This will be compared with treatment as usual (TAU). Participants will be adults with persistent physical symptoms (PPS) across three broad patient populations (i.e., fibromyalgia, non-cardiac chest pain and neurological symptoms). Randomisation will be stratified for clinic and disability. Follow-ups will be conducted at 9, 20, 40 and 52 weeks post-randomisation.

  • REC name

    London - Camberwell St Giles Research Ethics Committee

  • REC reference

    15/LO/0058

  • Date of REC Opinion

    25 Feb 2015

  • REC opinion

    Further Information Favourable Opinion