None listed
Conditions
Brief summary
Over their lifetime, 15% of Australians will experience major depressive disorder or bipolar disorder. Of those who access treatment, 20–50% will not achieve symptom remission with standard therapies. There is now consistent and compelling top-tier efficacy data from controlled research settings that lifestyle interventions targeting diet, exercise, sleep and/or substance use can improve the symptoms of mental disorders. Despite these significant advances and its enormous potential to alleviate the burden on GPs and psychological service providers, lifestyle-based mental health care is not available as part of mainstream mental health care. There are a range of complex reasons for the evidence–translation gap, one critical deficit is that almost no data exist from real world settings that compare effectiveness to standard care for individuals presenting to their GP with clinical depression. The HARMON-E Trial is a nationwide, non-inferiority trial that aims to determine the effectiveness of a group-based lifestyle program for reducing depressive symptoms compared to group-based psychotherapy. Participants include adults who have a diagnosis of either major depressive disorder or bipolar disorder, who are randomised to receive six telehealth group-based sessions with either psychologists for the psychotherapy arm, or a dietitian and exercise physiologist for the lifestyle arm. It is hypothesised that changes in mental health symptom outcomes for participants in the lifestyle program will not be inferior to those in the psychotherapy program.
Interventions
The intervention comprises six lifestyle telehealth group sessions, which are conducted by a dietitian and an exercise physiologist. Groups will include no more than 10 participants and will comprise five weekly sessions (weeks 1-5) and one fortnightly session (90min/session) over a 7-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 guid
The intervention comprises six lifestyle telehealth group sessions, which are conducted by a dietitian and an exercise physiologist. Groups will include no more than 10 participants and will comprise five weekly sessions (weeks 1-5) and one fortnightly session (90min/session) over a 7-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. These lifestyle goals are based on the four pillars of diet, physical activity, cessation of smoking, alcohol, and/or substance use, and 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 recommendations, images of exercise movements, progression suggestions, mindful physical activity, homework guides, barriers and enablers to lifestyle change, and goal setting. The format of the workbooks include, but are not limited to, visual guides of exercise implementation, Borg RPE intensity chart, visual examples of serving size, tracking and goal-setting sheets, meal planning templates and grocery shopping lists. All materials have been developed by graphic designers. Workbooks are mostly completed during sessions, however, some work may be completed in participants' own time, totaling no more than two hours over the seven-week period. Adherence to the lifestyle program will be ascertained through weekly surveys collecting participants' physical activity data (Simple Physical Activity Questionnaire (SIMPAQ)), and nutrition data will be collected pre- and post-intervention. Session attendance will be monitored, and participants will also complete feedback questions at the end of each session using the zoom poll feature. The results of these polls will be used to guide the structure of future sessions to enhance participant engagement. Prior to the first session, participants also will have a one-on-one, 30 minute video call with one of the interventionists (dietitian or exercise physiologist) who will be conducting the group sessions. This one-on-one video call will occur within the week prior to their first group session and will include an introduction, summary of group session guidelines, program overview, brief medical history, weight and dieting history, a discussion of participant's concerns or challenges, and a summary of the physical activity content.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 capacity to provided informed consent and converse in English (or attend the program/assessments with a carer/companion who does) 5. Are suited to participation and engagement in a structured group-based lifestyle or psychotherapy program for 8 weeks 6. Have basic computer and internet literacy
Exclusion criteria
1. Endorse all the following lifestyle behaviours: a. Non-smoker Identified by answering ‘no’ to pre-screening question: Do you regularly smoke, chew or consume tobacco (current not past use)? b. Report an optimal diet Meeting the Australian Dietary Guidelines for fruit and vegetable intake c. Sleep quality High sleep quality Identified as having 7-9 hours of sleep most nights of the week d. Physical activity Identified by exceeding the national guidelines for physical activity in Australia e. Alcohol & drug use Identified by no recreational drug use and not exceeding alcohol recommendations in Australia 2. Severe food allergies, intolerances, aversions or malabsorption issues 3. Medically unfit to engage in an exercise program (may be determined by treating clinician) 4. Pregnant, breastfeeding, or planning pregnancy within the next year 5. Socio-cultural, religious, medical reasons precluding participation in a lifestyle intervention 6. Known or suspected clinically unstable systemic medical disorder 7. Participation in another study that involves an intervention 8. Current, or history of, a formal diagnosis and/or treatment for an eating disorder Determined through online pre-screening questions: a) “Have you ever received a diagnosis or treatment for an eating disorder?” If a participant answers ‘Yes’ to this question they will be excluded from the study. b) In order to screen for undiagnosed eating disorders, all proceeding participants will complete the Sick, Control, One, Fat, Food (SCOFF) questionnaire. If an individual scores 3 or above, they will be excluded from the study. 9. Received treatment for an acute mental health concern in an inpatient setting or emergency department (e.g. suicidality, severe depressive state, mania, psychosis) within the last 30 days 10. Commencement of a new, duplicating treatment (e.g. medication, inpatient admission, psychotherapy) for a mental illness in the last 30 days 11. Experienced an episode of hypomania or mania in the last 30 days
Outcome results
None listed