Mindfulness in Chest Pain - a Feasibility Randomized Controlled Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-03-30

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.

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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.

Conditions

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Chest Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Simple 1:1 randomization.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The research staff conducting the outcome follow-up will be blinded to the randomization.

Study Groups

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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.

Group Type EXPERIMENTAL

MBCT (Mindfulness Based Cognitive Therapy)

Intervention Type BEHAVIORAL

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MBCT (Mindfulness Based Cognitive Therapy)

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

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No