Mindfulness in Chest Pain - a Feasibility Randomized Controlled Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chest Pain

Intervention / Treatment
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* Behavioral: MBCT (Mindfulness Based Cognitive Therapy)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Simple 1:1 randomization.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: MBCT (Mindfulness Based Cognitive Therapy)<br>* MBCT is recognized behavior therapy for patients with recurrent depression. The program will be adapted for patients with chest pain.<br>|
| No Intervention: Control group<br>These participants will continue to receive any treatment (or no treatment) by their primary care physicians. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness to participate in mindfulness-based behaviour therapy | To assess the number of patients with persistent chest pain without a heart condition who would be willing (and consent) to participate in mindfulness-based behaviour therapy | 8 months | 
| Compliance with mindfulness-based behavior therapy | To assess compliance with the mindfulness program by participation in the 8-week sessions and home practice. Each participant will be given a worksheet to complete for home practice and their experience. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent chest pain | To assess the number of patients diagnosed as non-cardiac chest pain who have persistent chest pain. This will be ascertained during the initial phone call by the research team. It will be further assessed in terms of physical limitation and frequency by the Seattle Angina Questionnaire at baseline and at follow-up. However, as this is a feasibility study, it is not powered to demonstrate statistically significant changes. | 8-months | 
| Prevalence of general anxiety and depression | To assess the prevalence of general anxiety and depression by means of Hospital Anxiety and Depression Scale questionnaire at baseline and at follow-up. However, as this is a feasibility study, it is not powered to demonstrate statistically significant changes. | 8- months | 
| Prevalence of cardiac anxiety | To assess the prevalence of heart-focussed anxiety with Cardiac Anxiety Questionnaire (CAQ) at baseline and follow-up. However, as this is a feasibility study, it is not powered to demonstrate statistically significant changes. | 8 months | 
| State of mindfulness | Each participant's state of mindfulness will be assessed using Five Facet Mindfulness Questionnaire at baseline and follow-up. However, as this is a feasibility study, it is not powered to demonstrate statistically significant changes. | 8-months | 
| Generic health related quality of life | Each participant's quality of life, including limitations in bodily and mental functioning associated with persistent chest pain, will be assessed by means of EuroQuol-5 questionnaire. However, as this is a feasibility study, it is not powered to demonstrate statistically significant changes. | 8-months | 
| Health resource utilization | The study will evaluate the utilization of health resources in terms of the number of visits to the hospital (as in-patient or out-patient) and primary care using Adult Service Use Schedule (AD-SUS) at baseline and follow-up. | 8-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chest pain, non-cardiac, mindfulness