Evaluating the effectiveness of a comprehensive lifestyle therapy program versus psychological care for managing mood disorders: The HARMON-E Trial

INTERVENTION: The intervention comprises si Xlifestyle telehealth group sessions, which are conducted by dietitians and exercise physiologists. Groups will include no more than 10 participants and will comprise four weekly sessions (weeks 1‐4) and two fortnightly sessions (90min/session) over an 8‐week period. Sessions will include general nutrition advice, which is based on a Mediterranean‐type diet, and physical activity advice, which is based on the current Australian recommended physical activity guidelines of 150mins/week of moderate physical activity (or 75mins/week of vigorous physical activity – or equivalent combination of both). Regarding resistance exercises, participants conduct these both during sessions and during their own time, outside of sessions. Participants are encouraged to start with exercises that they like completing, and complete three sets of eight repetitions, starting at 15‐minutes per session and building this up over time, aiming for most days of the week, and using the Borg RPE 1‐10 as a measure of intensity. Participants are provided with resistance bands to assist with exercise progression, and resistance exercises include, but are not limited to, high push‐ups, single arm rows, hip hinge, body weight squats, and body weight lunges. Sessions will also include discussions to support goal setting and lifestyle behaviour change. Participants may also nominate other lifestyle targets that are critical to the achievement of the core goals (e.g., alcohol, smoking, drug use, sleep hygiene). Participants are also provided workbooks, which have been specifically designed for this trial. Contents of the workbooks include, but are not limited to, meeting guidelines, healthy eating pyramid and serving sizes, physical activity recommendation CONDITION: Major depressive disorder;Bipolar affective disorder; ; Major depressive disorder ; Bipolar affective disorder Mental Health ‐ Depression Mental Health ‐ Other mental health disorders PRIMARY OUTCOME: Depression symptoms assessed using the Montgomery‐Asberg Depression Rating Scale (MADRS).[Baseline, 8 weeks post commencement of intervention (primary endpoint), 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] INCLUSION CRITERIA: 1. Are 18 years or older 2. Have experienced a major depressive episode in the past two years 3. Score equal to or greater than 20 on the MADRS 4. Have experienced a period euthymic mood for a period longer than two weeks in the past two years 5. Have capacity to provided informed consent and converse in English (or attend the program/assessments with a carer/companion who does) 6. Are suited to participation and engagement in a structured group‐based lifestyle or psychotherapy program for 8 weeks 7. Have basic computer and internet literacy SECONDARY OUTCOME: Anxiety symptoms assessed using the Generalised Anxiety Disorder scale (GAD‐7).[Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Blood glucose assessed from fasting blood samples.[Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Health service use is assessed using a brief resource use questionnaire, which was designed specifically for this study, [Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Irritable bowel syndrome diagnosis assessed using a single‐item, self‐developed question to assess the proportion of participants who have been told they have irritable bowel syndrome (IBS) by a general practitioner or gastroenterologist., [Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Lipid profile assessed from fasting blood samples.[Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Mental health recovery measures assessed using the the Mental Health Recovery Measure (MHRM). [Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Nutrition habits assessed using the Dietary Questionnaire for Epidemiological Studies version 3.2 (DQES v3.2),[Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Physical activity assessed using the Simple Physical Activity Questionnaire (SIMPAQ).[Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Psychosis symptoms assessed using the Early Psychosis Questionnaire, [Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Quality of life assessed using the Assessment of Quality of Life (AQoL 4D) questionnaire. [Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Sleep difficulties assessed using the Insomnia Severity Inde X(ISI). [Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Smoking, alcohol and drug use assessed using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST),[Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Social support assessed using the Medical Outcome Study Social Support Survey (MOS‐SSS), [Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Stool consistency assessed using the Bristol stool chart.[Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.] Weight management assessed from self‐reported weight and height. [Baseline, 8 weeks post commencement of intervention, 16 weeks post commencement of intervention, and 6 months post commencement of intervention.]