Integrating MEditatioN inTO heaRt disease (The MENTOR study): Phase II randomised controlled feasibility study protocol

Rao, A; DiGiacomo, M; Phillips, JL; Newton, PJ; Zecchin, R; Denniss, AR; Hickman, LD

Integrating MEditatioN inTO heaRt disease (The MENTOR study): Phase II randomised controlled feasibility study protocol

Rao, A

DiGiacomo, M

Phillips, JL Newton, PJ Zecchin, R Denniss, AR Hickman, LD

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Publisher:: Elsevier BV
Publication Type:: Journal Article
Citation:: Collegian, 2022
Issue Date:: 2022

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Field	Value	Language
dc.contributor.author	Rao, A https://orcid.org/0000-0002-7904-5556
dc.contributor.author	DiGiacomo, M https://orcid.org/0000-0001-5484-8224
dc.contributor.author	Phillips, JL
dc.contributor.author	Newton, PJ
dc.contributor.author	Zecchin, R
dc.contributor.author	Denniss, AR
dc.contributor.author	Hickman, LD
dc.date.accessioned	2022-04-20T02:10:35Z
dc.date.available	2022-04-20T02:10:35Z
dc.date.issued	2022
dc.identifier.citation	Collegian, 2022
dc.identifier.issn	1322-7696
dc.identifier.uri	http://hdl.handle.net/10453/156503
dc.description.abstract	Background: Additional support services are required to identify and manage poor psychological health symptoms in one in five patients who attend cardiac rehabilitation programs. Meditation has been identified as a low-cost accessible adjunct to conventional therapies and has demonstrated a potential benefit to reducing cardiovascular risk. Aim: This protocol reports on the design and methods of a study that aims to determine the feasibility, acceptability and preliminary efficacy of integrating a meditation intervention into an existing cardiac rehabilitation program for the reduction of depression and anxiety symptoms in people with cardiovascular disease. Methods: This is a mixed methods phase II randomised controlled feasibility pilot study. Sixty patients will be randomised to meditation (1 session weekly for six weeks) and usual cardiac rehabilitation (6 week/12 session outpatient cardiac rehabilitation) or to usual cardiac rehabilitation. Measurements will be conducted at baseline, 6 weeks and 3 months. Preliminary outcomes include feasibility and acceptability of meditation (recruitment, screening, randomisation and attrition rates), and depression, anxiety, stress, salivary cortisol, blood pressure and heart rate outcomes. Participants will be invited to attend a semistructured interview at 6 weeks to explore their experiences of participating in meditation. Health professionals will also be interviewed to ascertain their perspectives of integrating meditation into cardiovascular secondary prevention programs. Discussion: This study will provide preliminary understanding of the feasibility acceptability and preliminary efficacy of meditation as an adjunct therapy for people who may require additional psychological health support. These results may also highlight signals of improvement in psychological health symptoms and inform the development of a future phase III randomised controlled trial.
dc.language	en
dc.publisher	Elsevier BV
dc.relation.ispartof	Collegian
dc.relation.isbasedon	10.1016/j.colegn.2021.09.002
dc.rights	info:eu-repo/semantics/embargoedAccess
dc.subject	1110 Nursing
dc.subject.classification	Nursing
dc.title	Integrating MEditatioN inTO heaRt disease (The MENTOR study): Phase II randomised controlled feasibility study protocol
dc.type	Journal Article
utslib.for	1110 Nursing
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
pubs.organisational-group	/University of Technology Sydney/Strength - CHT - Health Technologies
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney/Centre for Health Technologies (CHT)
utslib.copyright.status	open_access	*
pubs.consider-herdc	false
utslib.copyright.embargo	2024-01-01T00:00:00+1000Z
dc.date.updated	2022-04-20T02:10:33Z
pubs.publication-status	Published

Abstract:

Background: Additional support services are required to identify and manage poor psychological health symptoms in one in five patients who attend cardiac rehabilitation programs. Meditation has been identified as a low-cost accessible adjunct to conventional therapies and has demonstrated a potential benefit to reducing cardiovascular risk. Aim: This protocol reports on the design and methods of a study that aims to determine the feasibility, acceptability and preliminary efficacy of integrating a meditation intervention into an existing cardiac rehabilitation program for the reduction of depression and anxiety symptoms in people with cardiovascular disease. Methods: This is a mixed methods phase II randomised controlled feasibility pilot study. Sixty patients will be randomised to meditation (1 session weekly for six weeks) and usual cardiac rehabilitation (6 week/12 session outpatient cardiac rehabilitation) or to usual cardiac rehabilitation. Measurements will be conducted at baseline, 6 weeks and 3 months. Preliminary outcomes include feasibility and acceptability of meditation (recruitment, screening, randomisation and attrition rates), and depression, anxiety, stress, salivary cortisol, blood pressure and heart rate outcomes. Participants will be invited to attend a semistructured interview at 6 weeks to explore their experiences of participating in meditation. Health professionals will also be interviewed to ascertain their perspectives of integrating meditation into cardiovascular secondary prevention programs. Discussion: This study will provide preliminary understanding of the feasibility acceptability and preliminary efficacy of meditation as an adjunct therapy for people who may require additional psychological health support. These results may also highlight signals of improvement in psychological health symptoms and inform the development of a future phase III randomised controlled trial.

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http://hdl.handle.net/10453/156503