Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial

Trudie Chalder, Meenal Patel, Kirsty James, Matthew Hotopf, Philipp Frank, Katie Watts, Paul McCrone, Anthony David, Mark Ashworth, Mujtaba Husain, Toby Garrood, Rona Moss-Morris, Sabine Landau, Trudie Chalder, Meenal Patel, Kirsty James, Matthew Hotopf, Philipp Frank, Katie Watts, Paul McCrone, Anthony David, Mark Ashworth, Mujtaba Husain, Toby Garrood, Rona Moss-Morris, Sabine Landau

Abstract

Background: Persistent 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.

Methods: A 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.

Discussion: This 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 registration: ClinicalTrials.gov NCT02426788. Registered 27 April 2015. Overall trial status: Ongoing; Recruitment status: No longer recruiting.

Keywords: Cognitive behavioural therapy (CBT); Medically unexplained symptoms; Randomised controlled trial (RCT); Secondary care.

Conflict of interest statement

MH reported grants from Innovative Medicines Initiative and European Federation of Pharmaceutical Industries and Associations, outside the submitted work. In addition, TC and RMM declared the following; Organisational financial interests: TC received ad hoc payments for conducting workshops on evidence-based treatments for persistent physical symptoms. TC has received grants from NIHR programme grants, HTA, RfPB, Guy’s and St Thomas Charity, King’s Challenge Fund, Muscular Dystrophy, Multiple Sclerosis Society. KCL received payment from Taylor and Francis for editorial role. RMM currently receives grant funding from NIHR programme grants, Breast Cancer Now, Crohn’s and Colitis UK, and National MS Society. In the previous 36 months, RMM received funding from MS society UK and NIHR HTA. In 2019, payments from Taylor and Francis to KCL for RMM’s role as Editor of Health Psychology Review. Payments for adhoc lectures and workshops on Long term conditions. Personal financial interests: TC is the author of several self-help books on chronic fatigue and received royalties in the past. TC received expenses and ad hoc payment for role as external examiner NUI Galway and Waterford Institute of Technology. TC received expenses for keynote speeches at UK Society for Behavioural Medicine, BABCP Conferences (travel and accommodation). TC received ad hoc payments for conducting workshops on evidence-based treatments for persistent physical symptoms. RMM received payments for her role as National Advisor to NHS England for Increasing Access to Psychological Therapies (IAPT) for People with Long Term Conditions from 2011 to 2016. RMM received ad hoc payments for workshop training in IBS in 2017 and 2018 and this will continue in 2019. RMM receives ad hoc consultancy payments from Mahana therapeutics and this is likely to continue in 2019. RMM has stock options in Mahana therapeutics. RMM received travel expenses for keynote speech to Internal Society of Behavioural Medicine. In 2019 RMM will be a keynote speaker for Association for Researchers in Psychology and Health (the Netherlands), European Health Psychology Society Annual Conference (Croatia), and the 9th World Congress of Behavioural and Cognitive Therapies (Germany). Travel and accommodation expenses will be reimbursed. All other authors declare no conflicts of interest. The authors acknowledge the financial support of the Department of Health via the National Institute for Health Research (NIHR) Specialist Biomedical Research Centre for Mental Health award to the South London and Maudsley NHS Foundation Trust (SLaM) and the Institute of Psychiatry at King’s College London. The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Figures

Fig. 1
Fig. 1
Logic Model of PRINCE Secondary illustrating the potential benefits of using a transdiagnostic approach. MUS, Medically Unexplained Symptoms; NHS, National Health Service; WSAS, Work and Social Adjustment Scale; PHQ-9, Patient Health Questionnaire – 9 item Scale; GAD-7, Generalised Anxiety Disorder – 7 item Scale; PHQ-15, Patient Health Questionnaire – 15 item Scale
Fig. 2
Fig. 2
PRINCE Secondary CONSORT Diagram of Study Procedure

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