NCT04151121

Mindfulness in Chest Pain - a Feasibility Randomized Controlled Study

Mindfulness Based Intervention in Patients With Persistent Pain in Chest (MIPIC) of Non-Cardiac Cause - a Feasibility Randomised Control Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chest Pain

Interventions

Type	Name	Description
BEHAVIORAL	MBCT (Mindfulness Based Cognitive Therapy)	MBCT is recognized behavior therapy for patients with recurrent depression. The program will be adapted for patients with chest pain.

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-09-30
• Completion: 2021-03-30
• First posted: 2019-11-05
• Last updated: 2022-05-02

Locations

1 site across 1 country: United Kingdom