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

Overview

Journal BMC Psychiatry

Publisher Biomed Central

Specialty Psychiatry

Date 2022 Mar 29

PMID 35346115

Authors

Lauren M Young

Steve Moylan

Tayla John

Megan Turner

Rachelle Opie

Meghan Hockey

Dean Saunders

Courtney Bruscella

Felice Jacka

Megan Teychenne

Simon Rosenbaum

Khyati Banker

Sophie Mahoney

Monica Tembo

Jerry Lai

Niamh Mundell

Grace McKeon

Murat Yucel

Jane Speight

Pilvikki Absetz

Vincent Versace

Mary Lou Chatterton

Michael Berk

Sam Manger

Mohammadreza Mohebbi

Mark Morgan

Anna Chapman

Craig Bennett

Melissa OShea

Tetyana Rocks

Sarah Leach

Adrienne ONeil

Affiliations

Soon will be listed here.

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.

Trial Registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12621000387820 , Registered 8 April 2021.

Citing Articles

Clinical and cost-effectiveness of remote-delivered, online lifestyle therapy versus psychotherapy for reducing depression: results from the CALM non-inferiority, randomised trial.

ONeil A, Perez J, Young L, John T, Turner M, Saunders D Lancet Reg Health West Pac. 2024; 49:101142.

PMID: 39381019 PMC: 11459004. DOI: 10.1016/j.lanwpc.2024.101142.

Evaluating the effectiveness of a multi-component lifestyle therapy program versus psychological therapy for managing mood disorders (HARMON-E): protocol of a randomised non-inferiority trial.

Davis J, Connolly M, Young L, Turner M, Mahoney S, Saunders D BMC Psychiatry. 2024; 24(1):653.

PMID: 39363192 PMC: 11450988. DOI: 10.1186/s12888-024-06098-z.

Clinical guidelines for the use of lifestyle-based mental health care in major depressive disorder: World Federation of Societies for Biological Psychiatry (WFSBP) and Australasian Society of Lifestyle Medicine (ASLM) taskforce.

Marx W, Manger S, Blencowe M, Murray G, Ho F, Lawn S World J Biol Psychiatry. 2022; 24(5):333-386.

PMID: 36202135 PMC: 10972571. DOI: 10.1080/15622975.2022.2112074.

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