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.

CALM试验数据集源自一项单中心、双臂、个体随机分组治疗的非劣效性试验，旨在评估整合式生活方式干预方案（CALM）相较于心理治疗，在改善新冠相关心理健康问题人群抑郁症状方面的有效性与成本效益。该试验聚焦身心健康双重结局，两项干预措施均通过远程医疗（telehealth）方式实施，干预周期为8周。本数据集共纳入184名18岁及以上的参与者，这些人群均存在显著心理痛苦、焦虑和/或抑郁症状，且痛苦量表5（Distress Questionnaire-5, DQ5）得分大于8分。参与者被随机分配至两组：一组为整合饮食与身体活动模块的CALM干预方案组，另一组为心理治疗组。本试验的主要研究目标为验证CALM方案在改善抑郁症状方面非劣于心理治疗，次要目标则包括评估其他身心健康结局指标，例如心血管生物标志物。