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
Deakin UniversityDataset description
The CALM Trial dataset stems from a single-site, two-arm, individually randomized group treatment, non-inferiority trial aimed at evaluating the effectiveness and cost-effectiveness of an integrated lifestyle program (CALM) versus psychotherapy in reducing symptoms of depression in individuals experiencing COVID-19 related mental health issues. The trial focuses on both mental and physical health outcomes, leveraging telehealth delivery for both interventions over an 8-week period. The dataset involves 184 participants aged 18 years and above, who are experiencing elevated distress, anxiety, and/or depression (Distress Questionnaire-5, DQ5 score >8). Participants are randomly assigned to either the CALM program, which integrates diet and physical activity components, or a psychotherapy program. The primary aim is to determine non-inferiority in depression symptom reduction, with secondary aims including the assessment of other mental and physical health outcomes such as cardiovascular biomarkers.Subjects
FOR: Mental Health |Identifiers
Source Study
Trial name (public)
Comparing the effects of a diet and exercise program versus psychological treatment for reducing depression in adults with COVID-19 related distress: The CALM trialTrial acronym
The CALM trial
Trial ID
ACTRN12621000387820
Purpose
Treatment
Phase
Not Applicable
Funding
Government body,National Health and Medical Research Council (NHMRC) Medical Research Future Fund (MRFF)
Scientific enquiries
Prof Adrienne O'Neil
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 ther .... Read more
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
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, medica .... Read more
Can healthy volunteers participate?
Yes
Population
Sample Size 182
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Anxiety , COVID-19 related psychological distress , Depression
Condition code Mental Health
Intervention
Intervention code Behaviour , Lifestyle
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/ot .... Read more
Comparison
Control group Active
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 9 .... Read more
Outcomes
Outcome: Depression symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)Timepoint: Baseline, 8 weeks (primary timepoint) and 9 months
Will individual participant data (IPD) for this trial be available?
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?
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.