Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001026718
Ethics application status
Approved
Date submitted
15/07/2022
Date registered
22/07/2022
Date last updated
11/02/2024
Date data sharing statement initially provided
22/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a comprehensive lifestyle therapy program versus psychological care for managing mood disorders: The HARMON-E Trial
Scientific title
Evaluating the effectiveness of a comprehensive lifestyle therapy program versus psychological care for managing mood disorders: The HARMON-E Trial
Secondary ID [1] 307520 0
None
Universal Trial Number (UTN)
U1111-1280-1753
Trial acronym
HARMON-E
Linked study record
ACTRN12621000387820, the CALM Trial was the pilot study for the current trial.

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 326948 0
Bipolar affective disorder 326949 0
Condition category
Condition code
Mental Health 324137 324137 0 0
Depression
Mental Health 324244 324244 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323982 0
Lifestyle
Intervention code [2] 323983 0
Treatment: Other
Comparator / control treatment
The control treatment involves the current gold-standard treatment of cognitive behavioural therapy for depression. Participants attend six telehealth group sessions that are facilitated by two registered psychologists with specialised clinical training or a provisional psychologist in a clinical training program under the supervision of a senior clinical psychologist. 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 seven-week period. Some homework is also completed of approximately 20 minutes each week, totaling three hours over the seven-week period.

Interventionists will use goal setting, aspects of motivational interviewing, socratic questioning, and cognitive restructuring during sessions. .The structure of each session will be: (1) Mindfulness/relaxation practice, (2) Check in and homework review, (3) Introduction of new concepts/skills, (4) Skills discussion or practice, (5) Homework discussion, (6) Close session with mindfulness/grounding exercise. Participants are provided with a workbook that has been designed specifically for this trial.

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 psychologist interventionists 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 biopsychosocial history, introduction to SMART goal setting, and a discussion regarding home practice.
Control group
Active

Outcomes
Primary outcome [1] 331949 0
Depression symptoms assessed using the Montgomery-Asberg Depression Rating Scale (MADRS).
Timepoint [1] 331949 0
Baseline and 8 weeks post commencement of intervention (primary endpoint),
Secondary outcome [1] 411706 0
Anxiety symptoms assessed using the Generalised Anxiety Disorder scale (GAD-7).
Timepoint [1] 411706 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [2] 411912 0
Social support assessed using the Medical Outcome Study Social Support Survey (MOS-SSS),
Timepoint [2] 411912 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [3] 411913 0
Smoking, alcohol and drug use assessed using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST),
Timepoint [3] 411913 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [4] 411914 0
Sleep difficulties assessed using the Insomnia Severity Index (ISI).
Timepoint [4] 411914 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [5] 411915 0
Quality of life assessed using the Assessment of Quality of Life (AQoL 4D) questionnaire.
Timepoint [5] 411915 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [6] 411916 0
Health service use is assessed using a brief resource use questionnaire, which was designed specifically for this study,
Timepoint [6] 411916 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [7] 411917 0
Blood glucose assessed from fasting blood samples.
Timepoint [7] 411917 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [8] 411918 0
Stool consistency assessed using the Bristol Stool Form Scale
Timepoint [8] 411918 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [9] 411922 0
Mental health recovery measures assessed using the the Mental Health Recovery Measure (MHRM).
Timepoint [9] 411922 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [10] 411923 0
Nutrition habits assessed using the Dietary Questionnaire for Epidemiological Studies version 3.2 (DQES v3.2),
Timepoint [10] 411923 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [11] 411925 0
Physical activity assessed using the Simple Physical Activity Questionnaire (SIMPAQ).
Timepoint [11] 411925 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [12] 412045 0
Weight management assessed from self-reported weight and height.
Timepoint [12] 412045 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [13] 412066 0
Lipid profile assessed from fasting blood samples.
Timepoint [13] 412066 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [14] 425415 0
Bipolar depression rating scale (BDRS)
Timepoint [14] 425415 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [15] 425416 0
Patient Health Questionnaire (PHQ-9)
Timepoint [15] 425416 0
Baseline, 8 weeks, 16 weeks, and 6-months post commencement of intervention
Secondary outcome [16] 425417 0
General Self-Efficacy Scale (GSE)
Timepoint [16] 425417 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [17] 425418 0
Gut microbiome composition determined by analysis of stool samples
Timepoint [17] 425418 0
Baseline and 8 weeks post commencement of intervention
Secondary outcome [18] 425419 0
Medication adherence (MARS-5)
Timepoint [18] 425419 0
Baseline and 8 weeks post commencement of intervention

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be generated by a third-party statistician, independent of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to the intervention arm will be achieved using computer-generated block randomisation in a 1:1 ratio (intervention to control).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is an individually randomised group treatment (IRGT), non-inferiority design.

To compare continuous outcomes on the MADRS in the primary analysis to determine non-inferiority, the following steps will be taken:
a. A comparison of baseline measures and demographic/cluster variables across allocation groups.
b. A comparison of drop-out rates across allocation groups and clusters. Identification of variables associated with drop-out using binary logistic regression analysis.
c. A 3-level hierarchical regression analysis for primary outcome and secondary measures, allowing for correlations within facilities (level 3) and individuals (level 2). This is an intention-to-treat analysis in which changes between 8 weeks and baseline will be compared for the two allocation groups. Any demographic/facility variables associated with allocation group or drop-out rates will be controlled for in these analyses.
d. Follow-up analyses conducted for primary and secondary measures again using 3-level hierarchical regression analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
29/09/2022
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
378
Accrual to date
137
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 38061 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 311800 0
Government body
Name [1] 311800 0
National Health and Medical Research Council’s Medical Research Future Fund Million Minds Mission – 2020 Mental Health Research
Country [1] 311800 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Rd
Waurn Ponds VIC 3216
Australia
Country
Australia
Secondary sponsor category [1] 313272 0
None
Name [1] 313272 0
Address [1] 313272 0
Country [1] 313272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311244 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 311244 0
Ethics committee country [1] 311244 0
Australia
Date submitted for ethics approval [1] 311244 0
29/06/2022
Approval date [1] 311244 0
26/09/2022
Ethics approval number [1] 311244 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120434 0
Prof Adrienne O'Neil
Address 120434 0
IMPACT Institute, Deakin University
PO Box 281
Geelong, VIC 3220
Country 120434 0
Australia
Phone 120434 0
+61 3 522 73799
Fax 120434 0
Email 120434 0
[email protected]
Contact person for public queries
Name 120435 0
Jessica Davis
Address 120435 0
IMPACT Institute, Deakin University
PO Box 281
Geelong, VIC 3220
Country 120435 0
Australia
Phone 120435 0
+61 3 5227 3549
Fax 120435 0
Email 120435 0
[email protected]
Contact person for scientific queries
Name 120436 0
Jessica Davis
Address 120436 0
IMPACT Institute, Deakin University
PO Box 281
Geelong, VIC 3220
Country 120436 0
Australia
Phone 120436 0
+61 3 5227 3549
Fax 120436 0
Email 120436 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Available on a case-by-case basis at the discretion of Primary Sponsor, and available to members of the Health Studies National Data Asset (HeSANDA) initiative.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.