Mindfulness in Chest Pain - a Feasibility Randomized Controlled Study

NCT04151121 | Completed DMC

• 1 other identifier: 253106
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain

Keywords

chest pain; non-cardiac; mindfulness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Persistent chest pain

  8-months

• Prevalence of general anxiety and depression

  8- months

• Prevalence of cardiac anxiety

  8 months

• State of mindfulness

  8-months

• Generic health related quality of life

  8-months

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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

Interventions

MBCT (Mindfulness Based Cognitive Therapy) BEHAVIORAL

MBCT is recognized behavior therapy for patients with recurrent depression. The program will be adapted for patients with chest pain.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• University of Oxford: collaborator

Study Sites (1)

Harefield Hospital

London, Middlesex, UB9 6JH, United Kingdom

Location

Related Publications (10)

• Hoorweg BB, Willemsen RT, Cleef LE, Boogaerts T, Buntinx F, Glatz JF, Dinant GJ. Frequency of chest pain in primary care, diagnostic tests performed and final diagnoses. Heart. 2017 Nov;103(21):1727-1732. doi: 10.1136/heartjnl-2016-310905. Epub 2017 Jun 20.

  PMID: 28634285 BACKGROUND

• Tyrer P, Tyrer H, Morriss R, Crawford M, Cooper S, Yang M, Guo B, Mulder RT, Kemp S, Barrett B. Clinical and cost-effectiveness of adapted cognitive behaviour therapy for non-cardiac chest pain: a multicentre, randomised controlled trial. Open Heart. 2017 May 16;4(1):e000582. doi: 10.1136/openhrt-2016-000582. eCollection 2017.

  PMID: 28674627 BACKGROUND

• Mittal TK, Pottle A, Nicol E, Barbir M, Ariff B, Mirsadraee S, Dubowitz M, Gorog DA, Clifford P, Firoozan S, Smith R, Dubrey S, Chana H, Shah J, Stephens N, Travill C, Kelion A, Pakkal M, Timmis A. Prevalence of obstructive coronary artery disease and prognosis in patients with stable symptoms and a zero-coronary calcium score. Eur Heart J Cardiovasc Imaging. 2017 May 1;18(8):922-929. doi: 10.1093/ehjci/jex037.

  PMID: 28379388 BACKGROUND

• Kuyken W, Warren FC, Taylor RS, Whalley B, Crane C, Bondolfi G, Hayes R, Huijbers M, Ma H, Schweizer S, Segal Z, Speckens A, Teasdale JD, Van Heeringen K, Williams M, Byford S, Byng R, Dalgleish T. Efficacy of Mindfulness-Based Cognitive Therapy in Prevention of Depressive Relapse: An Individual Patient Data Meta-analysis From Randomized Trials. JAMA Psychiatry. 2016 Jun 1;73(6):565-74. doi: 10.1001/jamapsychiatry.2016.0076.

  PMID: 27119968 BACKGROUND

• Chambers JB, Marks EM, Hunter MS. The head says yes but the heart says no: what is non-cardiac chest pain and how is it managed? Heart. 2015 Aug;101(15):1240-9. doi: 10.1136/heartjnl-2014-306277. Epub 2015 Apr 16. No abstract available.

  PMID: 25882503 BACKGROUND

• Kisely SR, Campbell LA, Yelland MJ, Paydar A. Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy. Cochrane Database Syst Rev. 2015 Jun 30;2015(6):CD004101. doi: 10.1002/14651858.CD004101.pub5.

  PMID: 26123045 BACKGROUND

• Ludwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available.

  PMID: 18799450 BACKGROUND

• Robertson N, Javed N, Samani NJ, Khunti K. Psychological morbidity and illness appraisals of patients with cardiac and non-cardiac chest pain attending a rapid access chest pain clinic: a longitudinal cohort study. Heart. 2008 Mar;94(3):e12. doi: 10.1136/hrt.2006.100537. Epub 2007 May 31.

  PMID: 17540685 BACKGROUND

• Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.

  PMID: 7042457 BACKGROUND

• Mittal TK, Evans E, Pottle A, Lambropoulos C, Morris C, Surawy C, Chuter A, Cox F, de Silva R, Mason M, Banya W, Thakrar D, Tyrer P. Mindfulness-based intervention in patients with persistent pain in chest (MIPIC) of non-cardiac cause: a feasibility randomised control study. Open Heart. 2022 May;9(1):e001970. doi: 10.1136/openhrt-2022-001970.

  PMID: 35545356 DERIVED

MeSH Terms

Conditions

Chest Pain

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tarun K Mittal, MD, FRCR

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research staff conducting the outcome follow-up will be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simple 1:1 randomization.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: December 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: March 30, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available after study publication for a period of 3 years.
• Access Criteria: Data access requests will be reviewed by the study investigators. Requestors will be required to sign a Data Access Agreement.

Locations

GB (1)