Evaluating telehealth lifestyle therapy versus telehealth psychotherapy for reducing depression in adults with COVID-19 related distress: the curbing anxiety and depression using lifestyle medicine (CALM) randomised non-inferiority trial protocol

Young, Lauren M., Moylan, Steven, John, Tayla, Turner, Megan, Opie, Rachelle, Hockey, Meghan, Saunders, Dean, Bruscella, Courtney, Jacka, Felice, Teychenne, Megan, Rosenbaum, Simon, Banker, Khyati, Mahoney, Sophie, Tembo, Monica, Lai, Jerry, Mundell, Niamh, McKeon, Grace, Yucel, Murat, Speight, Jane, Absetz, Pilvikki, Versace, Vincent, Chatterton, Mary Lou, Berk, Michael, Manger, Sam, Mohebbi, Mohammadreza, Morgan, Mark, Chapman, Anna, Bennett, Craig, O'Shea, Melissa, Rocks, Tetyana, Leach, Sarah, and O'Neil, Adrienne (2022) Evaluating telehealth lifestyle therapy versus telehealth psychotherapy for reducing depression in adults with COVID-19 related distress: the curbing anxiety and depression using lifestyle medicine (CALM) randomised non-inferiority trial protocol. BMC Psychiatry, 22 (1). 219.

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Abstract

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.

Item ID: 74444
Item Type: Article (Scholarly Work)
ISSN: 1471-244X
Keywords: Depression, Diet, Exercise, Mental disorders, Mental health, Nutrition, Physical activity, Psychiatry, Psychotherapy
Copyright Information: © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Funders: National Health and Medical Research Council of Australia (NHMRC)
Projects and Grants: NHMRC GA133346, NHMRC #1194982, NHMRC #1156072, NHMRC #APP1195335
Date Deposited: 18 Oct 2022 02:53
FoR Codes: 32 BIOMEDICAL AND CLINICAL SCIENCES > 3202 Clinical sciences > 320221 Psychiatry (incl. psychotherapy) @ 50%
42 HEALTH SCIENCES > 4203 Health services and systems > 420313 Mental health services @ 25%
42 HEALTH SCIENCES > 4207 Sports science and exercise > 420702 Exercise physiology @ 25%
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