None listed
Conditions
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).
Interventions
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/o
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.
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
Yes
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
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. Commencement of a new, duplicating treatment (e.g. psychotherapy) for a mental illness within a one-month period prior to baseline OR continuing symptoms which are treatment resistant on medication. 9. Participation in another study that involves an intervention 10. Current or history of an eating disorder
Outcome results
None listed