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

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.