Abstract
BackgroundPersistent physical symptoms (PPS), also known as medically unexplained symptoms (MUS), affect approximately 50% of patients in secondary care and are often associated with disability, psychological distress and increased health care costs. Cognitive behavioural therapy (CBT) has demonstrated both short- and long-term efficacy with small to medium effect sizes for PPS, with larger treatment effects for specific PPS syndromes, including non-cardiac chest pain, irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS). Research indicates that PPS conditions share similar cognitive and behavioural responses to symptoms, such as avoidance and unhelpful beliefs. This suggests that a transdiagnostic approach may be beneficial for patients with PPS.MethodsA randomised controlled trial (RCT) will be conducted to evaluate the efficacy and cost-effectiveness of a transdiagnostic CBT-based intervention for PPS. 322 participants with PPS will be recruited from secondary care clinics. Participants stratified by clinic and disability level will be randomised to CBT plus standard medical care (SMC) versus SMC alone. The intervention consists of 8 CBT sessions delivered by a qualified therapist over a period of 20 weeks. Outcomes will be assessed at 9, 20, 40- and 52-weeks post randomisation. Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation. Secondary outcomes will include mood, symptom severity and clinical global impression at 9, 20, 40 and 52 weeks. Cost-effectiveness will be evaluated by combining measures of health service use, informal care, loss of working hours and financial benefits at 52 weeks.DiscussionThis trial will provide a powered evaluation of the efficacy and cost-effectiveness of a transdiagnostic CBT approach versus SMC for patients with PPS. It will also provide valuable information about potential healthcare pathways for patients with PPS within the National Health Service (NHS).Trial registrationClinicalTrials.gov NCT02426788. Registered 27 April 2015. Overall trial status: Ongoing; Recruitment status: No longer recruiting.
Highlights
Persistent physical symptoms (PPS), known as medically unexplained symptoms (MUS), affect approximately 50% of patients in secondary care and are often associated with disability, psychological distress and increased health care costs
Chalder et al BMC Psychiatry (2019) 19:307 (Continued from previous page). This trial will provide a powered evaluation of the efficacy and cost-effectiveness of a transdiagnostic Cognitive behavioural therapy (CBT) approach versus standard medical care (SMC) for patients with PPS
The Persistent physical symptoms reduction intervention (PRINCE) Secondary study will be the first trial worldwide to address the efficacy and costeffectiveness of a manual-based, transdiagnostic, approach for PPS. If it proves to be efficacious, this treatment approach could significantly improve overall functioning in patients with PPS and may lead to substantial long-term economic benefits to the National Health Service (NHS). This approach could be potentially beneficial for treating patients with other debilitating long-term conditions, including diabetes, hypertension and chronic kidney disease
Summary
Trial design A two-arm parallel group randomised controlled trial (RCT). Method Three hundred and twenty-two patients with PPS will be individually randomised to CBT plus SMC versus SMC alone. Willing and able to give written informed consent Headaches as their main and only PPS symptom (given the clinical complexity of differentiating headaches and migraine, headaches will be excluded) Non-epileptic seizures as their main and only PPS symptom. The trial team will be informed if a participant decides to withdraw consent for research follow-up. Patients who discontinue their treatment but do not withdraw from the study will be followed up. The treatment approach will be transdiagnostic and will be flexible to accommodate the needs of the individual and specific issues associated with specific problems It will focus on previously identified symptoms that are overlapping across patient groups included in the trial, as well as common cognitive and behavioural responses to symptoms.
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