PRINCE Primary: Integrated GP Care for Persistent Physical Symptoms - a Feasibility & Cluster Randomised Controlled Trial
Condition: Persistent Physical Symptoms
Study type: Interventional

Summary: 
      PRINCE primary is cluster randomised waiting list controlled trial to evaluate the
      feasibility of an integrated approach to care in general practice for adults with persistent
      physical symptoms (PPS). PPS is defined as physical symptoms with no obvious underlying
      organic. 240 patients with PPS recruited from 8-12 GP practices in London will be randomised
      to the integrated care approach plus treatment as usual (TAU) or TAU alone. The integrated GP
      approach consists of providing GPs with a short cognitive behaviour therapy (CBT) skills
      training, ongoing supervision, as well as written and audio-visual materials/guidelines. In
      addition, participants randomised to the intervention group will receive tailored CBT-based
      self-help materials (i.e. written and audio-visual materials).
    

Detailed description: 
      Patients with PPS are often severely functionally impaired and. They consume large amounts of
      healthcare and welfare benefits. There is an accumulating body of evidence showing that
      cognitive behavioural interventions can reduce levels of symptoms and improve overall
      functioning in patients with PPS. CBT has demonstrated both short-term and long-term efficacy
      with small to medium effect sizes for PPS. Larger treatment effects have been reported for
      specific PPS syndromes, including non-cardiac chest pain, Irritable Bowel Syndrome (IBS), and
      Chronic Fatigue Syndrome (CFS).

      General practitioners (GPs) play a major role in identifying and managing patients with PPS.
      A previous randomised parallel group pilot trial investigated the feasibility (i.e.
      recruitment, retention and acceptability) of implementing a primary care Symptoms Clinic for
      patients with PPS). The Symptoms Clinic comprised a structured set of consultations delivered
      by a specially trained GP with a strong interest in PPS. The intervention included exploring
      potential biological mechanisms underlying the PPS condition, empathetic support, and
      training patients in symptom-management (i.e. medication or cognitive behavioural
      techniques). The results indicated that the Symptoms Clinic was acceptable to the majority of
      patients randomised to the intervention group, and may have the potential to generate
      clinically significant benefits. However, this pilot study did not assess feasibility
      parameters referring to GPs' willingness to participate in the study and undergo specialised
      psychological training. Moreover, the intervention was carried out by only one GP, raising
      questions about the generalizability of the study.

      Managing patients with PPS can be highly challenging in general practice. Although GPs
      recognise the treatment of PPS as a responsibility of primary care, previous studies show
      that GPs often feel powerless, frustrated and helpless when encountering these patients.
      Furthermore, GPs frequently report that factors such as time constraints and the lack of
      psychological training prevents them from effectively addressing patients' psychosocial needs
      and developing appropriate doctor-patient communication skills.

      The aim of this study is to assess whether it is feasible to conduct an adequately powered
      future trial to evaluate the efficacy and cost-effectiveness of a CBT-based integrated GP
      care approach for treating patients with PPS (please refer to arms and interventions for more
      details).
    

Intervention name(s): Integrated GP Care
Intervention type(s): Behavioral
Intervention description(s): The overall aims of the intervention are to help the patient:
develop an understanding of the relationship between cognitive, emotional, physiological and behavioral aspects of their problem;
understand factors that may be maintaining the problem;
learn how to modify the behavioral and cognitive responses which may be maintaining the problem;
adopt a healthy sleep routine which can promote healthy living.
Hand-outs will be available for GPs to give to patients, but the structure of the intervention allows for treatment to be formulation-based so that particular issues raised in the consultation that might be maintaining symptom severity (e.g. avoidance) can be addressed.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: PRINCE Primary is a cluster randomised waiting list controlled trial to evaluate the acceptability and feasibility of an integrated approach to care in general practice for adults with PPS.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Medically unexplained symptoms; Primary care; Cognitive behaviour therapy skills; Cluster randomised controlled trial; Feasibility