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

Not Applicable

Recruiting

• Conditions: Major depressive disorder; Bipolar affective disorder; Mental Health - Depression; Mental Health - Other mental health disorders

• Registration Number: ACTRN12622001026718
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-22
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 378

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression symptoms assessed using the Montgomery-Asberg Depression Rating Scale (MADRS).[ Baseline and 8 weeks post commencement of intervention (primary endpoint),]