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

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Middlesex
      • London, Middlesex, United Kingdom, UB9 6JH
        • Harefield Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to participate in mindfulness-based behaviour therapy
Time Frame: 8 months
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
Time Frame: 8 months
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
Time Frame: 8-months
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
Time Frame: 8- months
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
Time Frame: 8 months
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
Time Frame: 8-months
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
Time Frame: 8-months
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
Time Frame: 8-months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Tarun K Mittal, MD, FRCR, Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 253106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share individual participant data with any other researcher that underlie results in a publication.

IPD Sharing Time Frame

Data will be available after study publication for a period of 3 years.

IPD Sharing Access Criteria

Data access requests will be reviewed by the study investigators. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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