CBT Plus SMC Compared to SMC for Persistent Physical Symptoms in Secondary Care (PRINCE)
PRINCE
The PRINCE Secondary Study: Persistent Physical Symptoms Reduction Intervention: a System Change and Evaluation in Secondary Care
1 other identifier
interventional
324
1 country
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
April 27, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedMay 9, 2019
August 1, 2018
3.5 years
April 22, 2015
May 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Work and social adjustment scale
Measures impairment in functioning
52 weeks post randomisation
Secondary Outcomes (9)
Persistent Physical Symptom Questionnaire
52 weeks post randomisation
Patient Health Questionnaire-15 (PHQ-15)
52 weeks post randomisation
Patient Health Questionnaire-9 (PHQ-9)
52 weeks post randomisation
Generalized Anxiety Disorder-7 (GAD-7)
52 weeks post randomisation
Clinical Global Impression (CGI)
52 weeks post randomisation
- +4 more secondary outcomes
Other Outcomes (1)
PSYCHLOPS
52 weeks post randomisation
Study Arms (2)
CBT+SMC
EXPERIMENTALCognitive behavioural therapy + Standard Medical Care (cognitive-behavioural therapy+SMC): 8 hour-long manual-based CBT sessions with a therapist, weekly or fortnightly.
Standard Medical Care (SMC)
NO INTERVENTIONParticipants assigned to the SMC group (i.e., control group) will receive all the treatment and support they would otherwise receive outside of a research trial.
Interventions
Behavioral: Cognitive behavioural therapy (CBT) The CBT intervention used in the trial has been adapted for people with PPS and it is based on a model of understanding PPS (Deary et al 2007). The therapy aims to help the patient develop an understanding of the relationship between cognitive, physiological and behavioural aspects of their problem; to understand factors that may be maintaining the problem and to learn how to modify their behavioural and cognitive responses in order to improve quality of life. The approach is transdiagnostic in that it targets processes and underlying mechanisms that affect disorders similarly, rather than focusing on how they are diagnostically different. The approach is personalised during therapy following a detailed assessment.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Guy's Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Queen Elizabeth Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
St Thomas' Hospital
London, United Kingdom
University Hospital Lewisham
London, United Kingdom
Princess Royal University Hospital
Orpington, United Kingdom
Related Publications (1)
Chalder T, Patel M, James K, Hotopf M, Frank P, Watts K, McCrone P, David A, Ashworth M, Husain M, Garrood T, Moss-Morris R, Landau S. 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. BMC Psychiatry. 2019 Oct 22;19(1):307. doi: 10.1186/s12888-019-2297-y.
PMID: 31640632DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Trudie Chalder, PhD
King's College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2015
First Posted
April 27, 2015
Study Start
July 1, 2015
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
May 9, 2019
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share