Effectiveness of a physical therapy program based on therapeutic physical exercise and health education to improve quality of life and health status in major depressive disorder: A mixed-method pilot study protocol

BackgroundMajor depressive disorder is a mood disorder with significant psychological and physical symptoms, leading to disability and severe consequences. It is influenced by genetic and environmental factors, causing neurotransmitter imbalances and inflammation. Given the high prevalence and impact, it is crucial to implement a health promotion and intervention program. Investigating the efficacy of physical therapy, including therapeutic exercise and health education, compared to psychiatric and psychological approaches, is essential to improve the quality of life for these patients. MethodsA concurrent nested mixed-methods study with quantitative dominance will be conducted. The quantitative study will be a quasi-experimental pilot study with a pre-post design. Additionally, this study includes a qualitative narrative design. Initial and post-intervention evaluations will include sociodemographic and clinical data. Quantitative data will be collected using the EQ-5D-3L, MADRS, NRS, GSE, and GCPC-UN-ESU questionnaires. These tools assess health status, depression severity, pain intensity, self-efficacy, and satisfaction levels. Qualitative data will be collected from focus groups with 6-8 participants. The question guide for patients will cover experiences with illness and intervention, while the guide for professionals will cover perceptions of patient management and observed barriers and facilitators. All participants will receive the same evidence-based intervention over 3 to 6 weeks, with 2 weekly sessions of approximately 45 minutes each. Each session will consist of Therapeutic Exercise and Health Education to improve physical condition and self-management skills. DiscussionThis study aims to fill the knowledge gap on the effectiveness of physical therapy interventions for quality of life, pain, and self-efficacy in hospitalized patients with major depressive disorder. It will evaluate the impact of therapeutic exercise and health education, alongside standard psychiatric, psychological, and nursing treatments. The findings will provide scientific insights and guide healthcare policy makers to incorporate physical therapy into hospital treatments for major depressive disorder. Clinical Trial registration: NCT06983405