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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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

32

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Middlesex
      • London, Middlesex, Royaume-Uni, UB9 6JH
        • Harefield Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Aucune intervention: Control group
These participants will continue to receive any treatment (or no treatment) by their primary care physicians.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Willingness to participate in mindfulness-based behaviour therapy
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Persistent chest pain
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

  • Chercheur principal: Tarun K Mittal, MD, FRCR, Royal Brompton & Harefield NHS Foundation Trust

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 décembre 2019

Achèvement primaire (Réel)

30 septembre 2020

Achèvement de l'étude (Réel)

30 mars 2021

Dates d'inscription aux études

Première soumission

30 octobre 2019

Première soumission répondant aux critères de contrôle qualité

1 novembre 2019

Première publication (Réel)

5 novembre 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 avril 2022

Dernière vérification

1 avril 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 253106

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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