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Trial registered on ANZCTR


Registration number
ACTRN12621000387820p
Ethics application status
Submitted, not yet approved
Date submitted
29/03/2021
Date registered
8/04/2021
Date last updated
8/04/2021
Date data sharing statement initially provided
8/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the effects of a diet and exercise program versus psychological treatment for reducing depression in adults with COVID-19 related distress: The CALM trial
Scientific title
Evaluating the effectiveness of telehealth lifestyle therapy versus telehealth psychotherapy for reducing depression in adults with COVID-19 related distress: The CALM trial
Secondary ID [1] 303629 0
None
Universal Trial Number (UTN)
U1111-1260-9850
Trial acronym
The CALM trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 319667 0
Anxiety 319668 0
COVID-19 related psychological distress 321013 0
Condition category
Condition code
Mental Health 317597 317597 0 0
Depression
Mental Health 317599 317599 0 0
Anxiety
Mental Health 318817 318817 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'CALM' intervention is a group-based program co-facilitated by allied health professionals (accredited exercise physiologist, accredited practising dietitian) which focusses on lifestyle modification specifically using dietary and exercise targets.

CALM’s objectives are to: (a) enhance daily lifestyle management for those living with depression, anxiety and distress; (b) improve social and emotional support through lifestyle-based goal attainment; and (c) improve links to ongoing clinical/other supports to help maintain lifestyle modification in the long term.

Approximately 8 groups (up to 12 participants each) will be invited to complete six 90-minute group-based sessions over an eight week period (four weekly sessions and two fortnightly sessions). The programs will be offered via telehealth (Zoom for Education) platforms.

A workbook designed specifically for this trial will be provided detailing session content, with resources for distress management, and goal setting/attainment in the COVID-19 context and beyond. While the CALM program will be evidence-based and manualised to allow for replication, it will also be guided by participant discussion and if appropriate, will be tailored to the individual needs of the group.

To support adherence, participants will be sent a food hamper to promote dietary change and a FitBit Alta to self-monitor their physical activity (pedometer) and sleep (total time asleep).

In between sessions, participants will complete goal setting and homework tasks such as: diet and physical activity tracking, identification of strategies to increase physical activity, practical activities to facilitate dietary change (e.g. completion of shopping lists, and apps to explore healthier alternatives) and mindful lifestyle exercises. Participants will be encouraged to spend 10 to 15 minutes each week on the homework tasks.

Monitoring of lifestyle throughout the intervention period (8 weeks) will be managed through tracking FitBit data and completion of a weekly ModiMed Diet Checklist.

All sessions will be recorded unless a participant does not consent. Approximately 10% will be independently assessed by two investigators to determine fidelity of both interventions.
Intervention code [1] 319014 0
Lifestyle
Intervention code [2] 319016 0
Behaviour
Comparator / control treatment
The psychotherapy control program will use a group-based, Cognitive Behavioural Therapy (CBT) model of care. CBT is a standard, evidence-based model for treating depression and anxiety (highly comorbid) that can be successfully delivered remotely. The program will be delivered by an experienced Senior Clinical Psychologist and a Provisional Psychologist.

The program will comprise the same schedule as the 'CALM' intervention: approximately 8 groups (up to 12 participants each) will complete six 90-minute group-based sessions over an eight week period (four weekly sessions and two fortnightly sessions). The programs will be offered via telehealth (Zoom for Education) platforms.

A workbook designed specifically for the psychotherapy arm of this study will be provided detailing session content with resources for distress management. In between sessions, participants will be encouraged to spend 5 to 10 minutes per day completing homework tasks related to session content (e.g. thought logs, mindfulness exercises).

To support adherence, participants will be sent a self care hamper.

All sessions will be recorded unless a participant is not consenting. Approximately 10% will be independently assessed by two investigators to determine fidelity of both interventions.
Control group
Active

Outcomes
Primary outcome [1] 325643 0
Depression symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 325643 0
Baseline, 8 weeks (primary timepoint) and 6 months
Secondary outcome [1] 388635 0
Anxiety symptoms as measured by the Generalized Anxiety Disorder scale (GAD-7)
Timepoint [1] 388635 0
Baseline, 8 weeks and 6 months
Secondary outcome [2] 388638 0
COVID-19 specific anxiety scores as measured by the Coronavirus Anxiety Scale (CAS)
Timepoint [2] 388638 0
Baseline, 8 weeks and 6 months
Secondary outcome [3] 388639 0
Perceived social support scores as measured by the 4-item version of the Medical Outcome Study Social Support Survey (MOS-SSS)
Timepoint [3] 388639 0
Baseline, 8 weeks and 6 months
Secondary outcome [4] 388640 0
Substance use as measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Timepoint [4] 388640 0
Baseline, 8 weeks and 6 months
Secondary outcome [5] 388641 0
Self-efficacy scores as measured by the 6-item Generalised Self-Efficacy (GSE) scale
Timepoint [5] 388641 0
Baseline, 8 weeks and 6 months
Secondary outcome [6] 388643 0
Insomnia severity score as measured by the Insomnia Severity Index (ISI)
Timepoint [6] 388643 0
Baseline, 8 weeks and 6 months
Secondary outcome [7] 388644 0
Quality-adjusted life-years (QALYs) as measured by the Assessment of Quality of Life (AQoL 4D)
Timepoint [7] 388644 0
Baseline, 8 weeks and 6 months
Secondary outcome [8] 388645 0
Health service use as measured by self-developed questionnaire
Timepoint [8] 388645 0
Baseline, 8 weeks and 6 months
Secondary outcome [9] 388646 0
Changes in cardiovascular disease biomarkers including levels of triglycerides, low density lipoprotein, high density lipoprotein, total cholesterol, fasting blood glucose, and systolic/diastolic blood pressure
Timepoint [9] 388646 0
Baseline, 8 weeks
Secondary outcome [10] 388647 0
Changes in anthropometric measures as measured by body mass index (BMI) and waist-to-hip ratio (WHR)
Timepoint [10] 388647 0
Baseline, 8 weeks
Secondary outcome [11] 388648 0
Gut microbiome composition as measured by whole genome shot-gun sequencing
Timepoint [11] 388648 0
Baseline, 8 weeks
Secondary outcome [12] 388649 0
Stool consistency scores as measured by a modified version of the Bristol Stool Form Scale (BSFS)
Timepoint [12] 388649 0
Baseline, 8 weeks
Secondary outcome [13] 388665 0
Proportion of participants with irritable bowel syndrome (IBS) as measured by a one-item self-developed questionnaire
Timepoint [13] 388665 0
Baseline, 8 weeks and 6 months
Secondary outcome [14] 388666 0
Dietary intake across five different food groups (1: cereal foods, sweets and snacks; 2: dairy products, meats and fish; 3: fruit; 4: vegetables; and 5: alcoholic beverages) as measured by Cancer Council Victoria's Dietary Questionnaire for Epidemiological Studies v3.2 (DQES v3.2)
Timepoint [14] 388666 0
Baseline, 8 weeks and 6 months
Secondary outcome [15] 388667 0
Physical activity levels as measured by the Simple Physical Activity Questionnaire (SIMPAQ)
Timepoint [15] 388667 0
Baseline, 8 weeks and 6 months
Secondary outcome [16] 388668 0
Muscular strength as measured by the number of repetitions in 30-second sit-to-stand test and 30-second bicep curl test
Timepoint [16] 388668 0
Baseline, 8 weeks
Secondary outcome [17] 388853 0
Medication adherence scores as measured by the Morisky Medication Adherence Scale (MMAS)
Timepoint [17] 388853 0
Baseline, 8 weeks and 6 months
Secondary outcome [18] 390868 0
Psychological distress scores as measured by the Kessler-10 (K-10)
Timepoint [18] 390868 0
Baseline, during every week of the intervention period (Weeks 1-8), 8 weeks and 6 months,
Secondary outcome [19] 390869 0
Dietary adherence scores as measured by the ModiMed Diet Weekly Checklist
Timepoint [19] 390869 0
Completed every week of intervention (Weeks 1-8) by participants in CALM group only
Secondary outcome [20] 390870 0
Physical activity adherence scores as measured by FitBit Alta data
Timepoint [20] 390870 0
Completed every week of intervention (Weeks 1-8) by participants in CALM group only

Eligibility
Key inclusion criteria
1. Are 18 years or older
2. Have a Distress Questionnaire-5 (DQ5) score >8 at enrolment
3. Are deemed suitable by a treating clinician for participation in a structured lifestyle or psychotherapy program for 8 weeks
4. Are willing to commit to six 90-minute sessions over an eight-week period
5. Are willing to provide blood and stool samples on two occasions
6. Have basic computer and internet literacy
7. Have capacity to provide informed consent and converse in English
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Aged <18 years
2. No/low distress (DQ5 score <8); or in crisis or suicidal at time of enrolment (as determined by treating clinician and/or case manager)
3. Known or suspected clinically unstable systemic medical disorder
4. Severe food allergies, intolerances, aversions or malabsorption issues
5. Medically unfit to engage in an exercise program (may be determined by treating clinician)
6. Pregnant, breastfeeding, or planning pregnancy within the next year
7. Socio-cultural, religious, medical reasons precluding participation in a lifestyle intervention
8. Diagnosed with or have commenced new treatment for, anxiety and/or depression, within a one-month period prior to baseline.
9. Participation in another study that involves an intervention
10. Current or history of an eating disorder

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)
Baseline and follow-up data will be collected by a research assistant who is blinded to intervention allocation. Baseline assessments will be conducted prior to participant’s randomisation and commencement to either program. Participants will be asked not to reveal the condition to which they have been assigned during the follow-up assessment.

The analyses will be performed by a biostatistician from the research team, who will be blinded to treatment allocation.
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 randomisation in a 1:1 ratio (intervention to control). As randomisation will only occur when there are sufficient enough participants to form groups (min. 5 per group), block randomisation is not feasible. Rather, a simple random allocation method will occur within groups of participants that are ready to be randomised. The allocation sequence will be generated by a third-party statistician, independent of the research team. After baseline assessment has been completed, participants will be randomly assigned to either the 'CALM' group or psychotherapy group.
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
Non-inferiority
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: To accept our primary non-inferiority hypothesis, the maximum allowed upper limit of the 95% CI (one-sided alpha of 5%) of between-group mean difference on the PHQ9 will be no larger than 2. This was based both on statistical reasoning (sample size and recruitment feasibility over the 18-month study period), clinical judgement and other psychotherapy trials using non-inferiority designs. Assuming a standard deviation of 4 , one-sided type I error=0.025 and 80% power, a total sample size of 160 (80 participants assigned to each group) will be required and inflated by 15% (n=184) to allow for attrition based on our other telehealth trials. Each program is delivered by the same co-facilitators so we anticipate few clustering effects based on demographic characteristics. However, groups may be correlated given they share clinical characteristics and will interact throughout the program. We have thus set the Intra Class Correlation at 0.01, equivalent to a conservative design effect of 1.25.

Data analysis: In non-inferiority trials, an intention to treat (ITT) analysis tends to bias towards making the intervention and control condition look similar. Therefore, all outcomes will be evaluated in the per protocol (PP) population (i.e., those attending the first session to which they were assigned) as it is more likely to reflect true differences between treatments. Analyses will be repeated for the ITT population. To compare continuous outcomes between-group mean difference and CI will be estimated using generalise estimation equation techniques, with Huber Sandwich Estimator of variance to account for clustering. One-sided type I error of 0.025 will be used for all non-inferiority analyses. Effect sizes will be calculated using Cohen’s d. Exploratory analyses will examine remission (post-treatment score < optimal cut-score for a probable diagnosis of depression on PHQ9 in patients who initially scored above Threshold) and recovery (reduction of at least 50% of pre-treatment PHQ9 scores) rates. Reliable improvement is defined as a reduction of 5+ points on PHQ9 scores based on severity classifications pre-to-post treatment.

Missing data: All analyses will be conducted with and without multiple imputations to deal with missing values using both PP and ITT approaches. The sensitivity of conclusions to baseline characteristic imbalances will be assessed via analysis of covariance adjusting for any characteristic exhibiting potentially important imbalances.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17974 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 31929 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 307159 0
Government body
Name [1] 307159 0
National Health and Medical Research Council (NHMRC) Medical Research Future Fund (MRFF)
Address [1] 307159 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 307159 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Road
Waurn Ponds
Victoria 3216
Country
Australia
Secondary sponsor category [1] 308795 0
None
Name [1] 308795 0
None
Address [1] 308795 0
Country [1] 308795 0
Other collaborator category [1] 281682 0
Hospital
Name [1] 281682 0
Barwon Health
Address [1] 281682 0
University Hospital Geelong, Barwon Health
Bellerine St, Geelong, VIC, 3220
Country [1] 281682 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307274 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 307274 0
Research Ethics, Governance and Integrity (REGI) Unit
PO Box 281
Geelong Victoria 3220
Ethics committee country [1] 307274 0
Australia
Date submitted for ethics approval [1] 307274 0
25/11/2020
Approval date [1] 307274 0
Ethics approval number [1] 307274 0
Ethics committee name [2] 307275 0
Deakin University Human Research Ethics Committee
Ethics committee address [2] 307275 0
221 Burwood Highway
Burwood Victoria 3125
Ethics committee country [2] 307275 0
Australia
Date submitted for ethics approval [2] 307275 0
01/04/2021
Approval date [2] 307275 0
Ethics approval number [2] 307275 0

Summary
Brief summary
The mental health of the people of Australia and the world has deteriorated as a result of the COVID-19 pandemic. This COVID-19 related depression, anxiety and distress has and will continue to have long-lasting consequences for both mental and physical health. As mental and physical health are closely intertwined, sharing risk factors, pathways, prevention and management approaches, strategies that improve metabolic health can also provide substantial mental health benefits. However, while there is substantial evidence demonstrating the effectiveness of dietary or physical activity interventions in improving mental health, no such integrated programs exist within clinical practice.

The CALM Trial will be the first study to determine the effectiveness and cost-effectiveness of an integrated lifestyle program (CALM), focused on both diet and physical activity, in reducing depression symptoms, compared to a psychotherapy program. As a secondary aim, we will also assess the relative effectiveness of the CALM program in improving other mental and physical health outcomes (e.g., cardiovascular biomarkers).

The CALM Trial is a single-site, two-arm, individually randomised group treatment, non-inferiority trial. Both programs (CALM, psychotherapy) will be delivered over telehealth for an 8-week period (six 90-minute sessions). Group led sessions will be conducted by either allied health professionals (CALM) or an experienced Senior Clinical Psychologist and a Provisional Psychologist (psychotherapy). We plan to recruit 184 participants aged 18 years and above with with elevated distress, anxiety and/or depression (Distress Questionnaire-5, DQ5 score >8).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106646 0
A/Prof Adrienne O'Neil
Address 106646 0
IMPACT, Deakin University, HERB-B
PO Box 281
Geelong Victoria 3220
Country 106646 0
Australia
Phone 106646 0
+61 3 522 73799
Fax 106646 0
Email 106646 0
adrienne.oneil@deakin.edu.au
Contact person for public queries
Name 106647 0
Dr Lauren Young
Address 106647 0
IMPACT, Deakin University, HERB-B
PO Box 281
Geelong Victoria 3220
Country 106647 0
Australia
Phone 106647 0
+61 3 522 73837
Fax 106647 0
Email 106647 0
lauren.young@deakin.edu.au
Contact person for scientific queries
Name 106648 0
A/Prof Adrienne O'Neil
Address 106648 0
IMPACT, Deakin University, HERB-B
PO Box 281
Geelong Victoria 3220
Country 106648 0
Australia
Phone 106648 0
+61 3 522 73799
Fax 106648 0
Email 106648 0
adrienne.oneil@deakin.edu.au

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?
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Proposals should be directed to adrienne.oneil@deakin.edu.au
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 10939 0
Study protocol
Citation [1] 10939 0
Link [1] 10939 0
Email [1] 10939 0
Other [1] 10939 0
Available following publication
Attachment [1] 10939 0
Summary results
No Results