Mindfulness in Chest Pain - a Feasibility Randomized Controlled Study
Condition: Chest Pain
MeSH terms: Chest Pain
Study type: Interventional

Summary: 
      Non-cardiac chest pain (NCCP) is a common symptom in clinical practice with no satisfactory
      treatment. We plan to perform a feasibility randomized controlled trial (RCT) to explore the
      role of mindfulness therapy in patients with NCCP to ascertain the number of patients who
      would be willing to enroll and complete the mindfulness intervention. This will allow us to
      develop and refine the adaption of mindfulness therapy as well as assess the compliance.
    

Detailed description: 
      Chest pain is a common condition in primary care with the lifetime prevalence of no cardiac
      cause (NCCP) being 20-33 percent compared to 6-7 percent for cardiac chest pain. The latter
      patients obtain appropriate medical and interventional treatment but those with NCCP are
      often left with persistent symptoms, psychological distress, impaired quality of life, high
      unemployment, work absenteeism, and high use of healthcare resources. They are often treated
      with analgesics, proton-pump inhibitors, anxiolytics, but generally with little benefit.

      Mindfulness has grown in popularity in the last 2-3 decades as an accepted form of behavior
      therapy for the treatment of stress and depression. Several RCTs have been performed in
      patients with chronic pain, but none specific to chest pain. They have been heterogeneous in
      nature with low-quality evidence for improvement of pain with mindfulness. There is thus a
      requirement for larger, well-designed and rigorous RCTs in patients with chronic pain,
      including those with NCCP.

      With this feasibility RCT study, the investigators would like to obtain more information
      about some uncertainties that would allow them to conduct a larger, well-designed RCT. The
      investigators plan to recruit 50 participants from all those who have attended the chest pain
      clinic in the previous 12-months and randomize them in a simple 1:1 manner into receiving
      Mindfulness-based Cognitive Therapy (MBCT) therapy (intervention arm) or usual treatment by
      their general practitioner (control arm). The participants will undergo a basic clinical
      assessment with symptoms, heart-rate, blood pressure, height, body weight, cardiovascular
      risk factors. They will be required to complete different questionnaires to assess their
      chest pain limitation and frequency, general and cardiac-specific anxiety, mindfulness,
      quality of life, and health-related resource utilization at baseline and after completion of
      MBCT or usual treatment.
    

Intervention name(s): MBCT (Mindfulness Based Cognitive Therapy)
Intervention type(s): Behavioral
Intervention description(s): MBCT is recognized behavior therapy for patients with recurrent depression. The program will be adapted for patients with chest pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Simple 1:1 randomization.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chest pain; non-cardiac; mindfulness