Yoga, cognitive–behavioural therapy versus education to improve quality of life and reduce healthcare costs in people with endometriosis: a randomised controlled trial

IntroductionEndometriosis is a debilitating chronic inflammatory condition highly burdensome to the healthcare system. The present trial will establish the efficacy of (1) yoga and (2) cognitive–behavioural therapy (CBT), above (3) education, on quality of life, biopsychosocial outcomes and cost-eff...

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Bibliographic Details
Published in:BMJ open 2021-08, Vol.11 (8), p.e046603-e046603
Main Authors: Mikocka-Walus, Antonina, Druitt, Marilla, O"Shea, Melissa, Skvarc, David, Watts, Jennifer J, Esterman, Adrian, Tsaltas, Jim, Knowles, Simon, Harris, Jill, Dowding, Charlotte, Parigi, Elesha, Evans, Subhadra
Format: Article
Language:English
Subjects:
Behavior modification
Chronic illnesses
Clinical psychology
Cognitive therapy
Consent
Cost analysis
Design
Education
Endometriosis
Ethics
Fatigue
Intervention
Mental disorders
Mental health care
obstetrics
Obstetrics and Gynaecology
Pain management
Patients
psychiatry
Psychotherapy
Quality of life
Questionnaires
Surgeons
Surgery
Yoga
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Summary:IntroductionEndometriosis is a debilitating chronic inflammatory condition highly burdensome to the healthcare system. The present trial will establish the efficacy of (1) yoga and (2) cognitive–behavioural therapy (CBT), above (3) education, on quality of life, biopsychosocial outcomes and cost-effectiveness.Methods and analysisThis study is a parallel randomised controlled trial. Participants will be randomly allocated to yoga, CBT or education. Participants will be English-speaking adults, have a diagnosis of endometriosis by a qualified physician, with pain for at least 6 months, and access to internet. Participants will attend 8 weekly group CBT sessions of 120 min; or 8 weekly group yoga sessions of 60 min; or receive weekly educational handouts on endometriosis. The primary outcome measure is quality of life. The analysis will include mixed-effects analysis of variance and linear models, cost–utility analysis from a societal and health system perspective and qualitative thematic analysis.Ethics and disseminationEnrolment in the study is voluntary and participants can withdraw at any time. Participants will be given the option to discuss the study with their next of kin/treating physician. Findings will be disseminated via publications, conferences and briefs to professional organisations. The University’s media team will also be used to further disseminate via lay person articles and media releases.Trial registration numberACTRN12620000756921p; Pre-results.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2020-046603