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

Not Applicable

Active, not recruiting

• Conditions: Depression; Anxiety; COVID-19 related psychological distress; Mental Health - Depression; Mental Health - Anxiety; Mental Health - Other mental health disorders

• Registration Number: ACTRN12621000387820
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-08
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)[Baseline, 8 weeks (primary timepoint) and 9 months]