CBT Plus SMC Compared to SMC for Persistent Physical Symptoms in Secondary Care (PRINCE)
CompletedNot applicableNCT02426788
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- The PRINCE Secondary Study: Persistent Physical Symptoms Reduction Intervention: a System Change and Evaluation in Secondary Care
- Conditions
- Persistent Physical Symptoms (PPS)
- Interventions
- Behavioral: Cognitive behavioural therapy (CBT)
- Sponsor
- King's College London
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Start date
- 2015-07
- Primary completion
- 2019-01
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 7
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
* Adults (18 - 70 yrs) * Patients with PPS from broad patient populations (e.g., fibromyalgia, non-cardiac chest pain, postural orthostatic tachycardia syndrome, neurological symptoms); * Significant functional impairment/moderately severe disability - as indicated by the Work and Social Adjustment Scale (WSAS) score (i.e., a minimum score of 10); * Ability to complete diaries and questionnaires in English; * Willingness to complete all trial visits; * Ability to give written informed consent. Exclusion Criteria: * Active psychosis; * Factitious disorder; * Headaches as the only PPS; * Non-epileptic seizures * Current alcohol dependence or drug addiction as assessed by the clinician; * Current benzodiazepine use exceeding the equivalent of 10mg diazepam/day; * The patient is currently receiving CBT/CBT based approach psychotherapy, or has received CBT/CBT based approach psychotherapy in the past year, for their PPS; * The patient is thought to be at imminent risk of self-harm; * Patient is taking part in PRINCE Primary trial.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02426788