CBT Plus SMC Compared to SMC for Persistent Physical Symptoms in Secondary Care (PRINCE) (NCT02426788) | Clinical Trial Compass
CompletedNot Applicable
CBT Plus SMC Compared to SMC for Persistent Physical Symptoms in Secondary Care (PRINCE)
United Kingdom324 participantsStarted 2015-07
Plain-language 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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.