TY - JOUR
T1 - Evaluating telehealth lifestyle therapy versus telehealth psychotherapy for reducing depression in adults with COVID-19 related distress
T2 - the curbing anxiety and depression using lifestyle medicine (CALM) randomised non-inferiority trial protocol
AU - Young, Lauren M.
AU - Moylan, Steve
AU - John, Tayla
AU - Turner, Megan
AU - Opie, Rachelle
AU - Hockey, Meghan
AU - Saunders, Dean
AU - Bruscella, Courtney
AU - Jacka, Felice
AU - Teychenne, Megan
AU - Rosenbaum, Simon
AU - Banker, Khyati
AU - Mahoney, Sophie
AU - Tembo, Monica
AU - Lai, Jerry
AU - Mundell, Niamh
AU - McKeon, Grace
AU - Yucel, Murat
AU - Speight, Jane
AU - Absetz, Pilvikki
AU - Versace, Vincent
AU - Chatterton, Mary Lou
AU - Berk, Michael
AU - Manger, Sam
AU - Mohebbi, Mohammadreza
AU - Morgan, Mark
AU - Chapman, Anna
AU - Bennett, Craig
AU - O’Shea, Melissa
AU - Rocks, Tetyana
AU - Leach, Sarah
AU - O’Neil, Adrienne
N1 - Funding Information:
FJ has received industry support for research from Meat and Livestock Australia, Woolworths Limited, the A2 Milk Company, and Be Fit Foods, and travel support and speakers honoraria from Sanofi-Synthelabo, Janssen Cilag, Servier, Pfizer, Network Nutrition, Angelini Farmaceutica, Eli Lilly, Metagenics, and The Beauty Chef. FJ has written two books for commercial publication. MB has received Grant/Research Support from the NIH, Cooperative Research Centre, Simons Autism Foundation, Cancer Council of Victoria, Stanley Medical Research Foundation, Medical Benefits Fund, National Health and Medical Research Council, Medical Research Futures Fund, Beyond Blue, Rotary Health, A2 milk company, Meat and Livestock Board, Woolworths, Avant and the Harry Windsor Foundation, has been a speaker for Abbot, Astra Zeneca, Janssen and Janssen, Lundbeck and Merck and served as a consultant to Allergan, Astra Zeneca, Bioadvantex, Bionomics, Collaborative Medicinal Development, Janssen and Janssen, Lundbeck Merck, Pfizer and Servier – all unrelated to this work. NM has received Grant/Research support from Exercise and Sports Science Australia, unrelated to this work. TR has received grants, fellowships and research support from University of the Sunshine Coast, Australian Postgraduate Awards, Fernwood Foundation and Be Fit Food. TR received consultancy, honoraria and travel funds from Oxford University Press, the University of Melbourne, the University of Sydney, Bond University, University of Southern Queensland, Dietitians Association of Australia, Nutrition Society of Australia, The Royal Australian and New Zealand College of Psychiatrists, Academy of Nutrition and Dietetics, Black Dog Institute, Australian Rotary Health, Australian Disease Management Association, Department of Health and Human Services, Primary Health Networks, Barwon Health, West Gippsland Healthcare Group, Central West Gippsland Primary Care Partnership, Parkdale College, City of Greater Geelong and Global Age.
Funding Information:
The authors would like to acknowledge Jess Ward, Billi Jow McCarthy-Price, Sonia Terhaag, Emily Lovell, Belinda Robinson and Catherine Mazza for their contribution to program delivery, and Dr. Mojtaba Lotfaliany Abrand Abadi for conducting randomisation. We are very grateful to the members of the DSMB?Prof Barr Taylor, Dr. Mojtaba Lotfaliany Abrand Abadi, Dr. Rebecca Segrave and Mary Malakellis. We would also like to acknowledge the Community and Research Network (CARN) and Elizabeth Elms for input into program design and delivery. Finally, we would like to express our gratitude to the participants who volunteered their time for this study.
Funding Information:
This research project is funded by the National Health and Medical Research Council’s Medical Research Future Fund - COVID-19 Mental Health Research Australian Government Department of Health (GA133346). The funding body had no role in the design of the study, collection, analysis and interpretation of data, nor in the writing of the manuscript. AO is supported by a Future Leader Fellowship (#101160) from the Heart Foundation Australia and Wilson Foundation. FNJ is supported by an NHMRC Investigator Grant (#1194982). MB is supported by a NHMRC Senior Principal Research Fellowship (1156072). MH is supported by an Australian Rotary Health Ian Scott PhD Scholarship. MT2 is supported by a National Health and Medical Research Council Emerging Leadership Fellowship (APP1195335). JS is supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University. VV is supported by the Rural Health Multidisciplinary Training (RHMT) program. The contents of the published material are solely the responsibility of the individual authors and do not reflect the views of the funding bodies.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/3/27
Y1 - 2022/3/27
N2 - Background: There is increasing recognition of the substantial burden of mental health disorders at an individual and population level, including consequent demand on mental health services. Lifestyle-based mental healthcare offers an additional approach to existing services with potential to help alleviate system burden. Despite the latest Royal Australian New Zealand College of Psychiatrists guidelines recommending that lifestyle is a ‘first-line’, ‘non-negotiable’ treatment for mood disorders, few such programs exist within clinical practice. Additionally, there are limited data to determine whether lifestyle approaches are equivalent to established treatments. Using an individually randomised group treatment design, we aim to address this gap by evaluating an integrated lifestyle program (CALM) compared to an established therapy (psychotherapy), both delivered via telehealth. It is hypothesised that the CALM program will not be inferior to psychotherapy with respect to depressive symptoms at 8 weeks. Methods: The study is being conducted in partnership with Barwon Health’s Mental Health, Drugs & Alcohol Service (Geelong, Victoria), from which 184 participants from its service and surrounding regions are being recruited. Eligible participants with elevated psychological distress are being randomised to CALM or psychotherapy. Each takes a trans-diagnostic approach, and comprises four weekly (weeks 1-4) and two fortnightly (weeks 6 and 8) 90-min, group-based sessions delivered via Zoom (digital video conferencing platform). CALM focuses on enhancing knowledge, behavioural skills and support for improving dietary and physical activity behaviours, delivered by an Accredited Exercise Physiologist and Accredited Practising Dietitian. Psychotherapy uses cognitive behavioural therapy (CBT) delivered by a Psychologist or Clinical Psychologist, and Provisional Psychologist. Data collection occurs at baseline and 8 weeks. The primary outcome is depressive symptoms (assessed via the Patient Health Questionnaire-9) at 8 weeks. Societal and healthcare costs will be estimated to determine the cost-effectiveness of the CALM program. A process evaluation will determine its reach, adoption, implementation and maintenance. Discussion: If the CALM program is non-inferior to psychotherapy, this study will provide the first evidence to support lifestyle-based mental healthcare as an additional care model to support individuals experiencing psychological distress. Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12621000387820, Registered 8 April 2021.
AB - Background: There is increasing recognition of the substantial burden of mental health disorders at an individual and population level, including consequent demand on mental health services. Lifestyle-based mental healthcare offers an additional approach to existing services with potential to help alleviate system burden. Despite the latest Royal Australian New Zealand College of Psychiatrists guidelines recommending that lifestyle is a ‘first-line’, ‘non-negotiable’ treatment for mood disorders, few such programs exist within clinical practice. Additionally, there are limited data to determine whether lifestyle approaches are equivalent to established treatments. Using an individually randomised group treatment design, we aim to address this gap by evaluating an integrated lifestyle program (CALM) compared to an established therapy (psychotherapy), both delivered via telehealth. It is hypothesised that the CALM program will not be inferior to psychotherapy with respect to depressive symptoms at 8 weeks. Methods: The study is being conducted in partnership with Barwon Health’s Mental Health, Drugs & Alcohol Service (Geelong, Victoria), from which 184 participants from its service and surrounding regions are being recruited. Eligible participants with elevated psychological distress are being randomised to CALM or psychotherapy. Each takes a trans-diagnostic approach, and comprises four weekly (weeks 1-4) and two fortnightly (weeks 6 and 8) 90-min, group-based sessions delivered via Zoom (digital video conferencing platform). CALM focuses on enhancing knowledge, behavioural skills and support for improving dietary and physical activity behaviours, delivered by an Accredited Exercise Physiologist and Accredited Practising Dietitian. Psychotherapy uses cognitive behavioural therapy (CBT) delivered by a Psychologist or Clinical Psychologist, and Provisional Psychologist. Data collection occurs at baseline and 8 weeks. The primary outcome is depressive symptoms (assessed via the Patient Health Questionnaire-9) at 8 weeks. Societal and healthcare costs will be estimated to determine the cost-effectiveness of the CALM program. A process evaluation will determine its reach, adoption, implementation and maintenance. Discussion: If the CALM program is non-inferior to psychotherapy, this study will provide the first evidence to support lifestyle-based mental healthcare as an additional care model to support individuals experiencing psychological distress. Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12621000387820, Registered 8 April 2021.
KW - Depression
KW - Diet
KW - Exercise
KW - Mental disorders
KW - Mental health
KW - Nutrition
KW - Physical activity
KW - Psychiatry
KW - Psychotherapy
UR - http://www.scopus.com/inward/record.url?scp=85127226835&partnerID=8YFLogxK
U2 - 10.1186/s12888-022-03840-3
DO - 10.1186/s12888-022-03840-3
M3 - Article
C2 - 35346115
AN - SCOPUS:85127226835
SN - 1471-244X
VL - 22
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
M1 - 219
ER -
