Clinical trial NCT04151121: Mindfulness in Chest Pain - a Feasibility Randomized Controlled Study
Official title: Mindfulness Based Intervention in Patients With Persistent Pain in Chest (MIPIC) of Non-Cardiac Cause - a Feasibility Randomised Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Keywords: chest pain
non-cardiac
mindfulness
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2019-11-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Simple 1:1 randomization.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Willingness to participate in mindfulness-based behaviour therapy
timeFrame: 8 months
measure: Compliance with mindfulness-based behavior therapy
timeFrame: 8 months
Secondary outcomes:
measure: Persistent chest pain
timeFrame: 8-months
measure: Prevalence of general anxiety and depression
timeFrame: 8- months
measure: Prevalence of cardiac anxiety
timeFrame: 8 months
measure: State of mindfulness
timeFrame: 8-months
measure: Generic health related quality of life
timeFrame: 8-months
measure: Health resource utilization
timeFrame: 8-months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Harefield Hospital
state: Middlesex
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Tarun K Mittal, MD, FRCR
role: PRINCIPAL_INVESTIGATOR
References:
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