Background Major 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.

Methods A 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.

Discussion This 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

The authors have declared no competing interest.

NCT06983405

Yes

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

- CEICA PI25/233 - CETICA 38/3/24-25

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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The feasibility of this protocol has been carefully assessed by designing a low-to-moderate intensity intervention that can be adapted to the individual capacities of patients and the duration of their hospital stay. Strategies have been planned to ensure the quality of the qualitative data, such as verbatim transcription of the focus groups, inductive coding performed by two researchers independently, and the triangulation of data to ensure the credibility of the findings. The findings of this study will be disseminated through several channels to maximize their impact. Primary dissemination will occur through publication in peer-reviewed scientific journals, with PLOS ONE being the targeted journal. Presentations at national and international conferences related to physical therapy, mental health, and healthcare will also be pursued. Furthermore, the results will be shared with participating healthcare institutions and, if applicable, to the study participants. The potential for the development of clinical practice guidelines or recommendations based on the study's outcomes will be explored to facilitate the integration of physical therapy into standard care for hospitalized patients with major depressive disorder.