Mindfulness in Chest Pain - a Feasibility Randomized Controlled Study (MIPIC)

Royal Brompton & Harefield NHS Foundation Trust

Status: Completed

Conditions: Chest Pain

Treatments: Behavioral: MBCT (Mindfulness Based Cognitive Therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT04151121

253106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Attendance to the chest pain clinic within the last 12 months and no cardiac cause for chest pain were identified.
• Have persistent chest pain symptoms on or after usual treatment
• Ability to carry out the 8-week mindfulness course and required home practice.
• Able to understand verbal and written English.

Exclusion criteria

• Acute presentation with ECG changes and/ or raised enzymes at any time prior to enrolment.
• Known history of coronary artery disease.
• Under active psychiatric care or waiting for a psychological assessment or have received a prescription of a new psychoactive drug within the previous 3 months.
• Undergoing any other form of counselling or behaviour therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Intervention

Experimental group

Description:

The participants will receive MBCT (Mindfulness-Based Cognitive Therapy) as 2-hourly sessions over 8-weeks including a 6-hour session at the end of 6th week. The MBCT will be adapted for chest pain.

Treatment:

Behavioral: MBCT (Mindfulness Based Cognitive Therapy)

Control group

No Intervention group

Description:

These participants will continue to receive any treatment (or no treatment) by their primary care physicians.