Physical Therapy for Depression Quality of Life (Pilot Study Protocol)
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
- Major Depressive Disorder (MDD)
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Universidad San Jorge
- Enrolment target
- 40
- Started
- 1 September 2025
- Main results due
- April 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion and Exclusion Criteria for Patients with Major Depressive Disorder (MDD): Inclusion Criteria: * Be 18 years of age or older. * Be currently admitted to the short-stay inpatient unit of the Psychiatry Department at Royo Villanova Hospital (Zaragoza). * Have a physician-confirmed diagnosis of Major Depressive Disorder (MDD) according to current diagnostic criteria (ICD-10 or DSM-5). * Be receiving regular medical, psychological, and/or pharmacological treatment for their MDD. * Not require continuous supervision and control by nursing staff during data collection and the intervention. * Have provided written informed consent to participate in the study. Exclusion Criteria: * Presence of a comorbid physical or mental illness whose clinical characteristics and/or severity impede comprehension and/or adherence to the physical therapy interventions. * Presence of a physical or mental dysfunction or disability that constitutes a total or partial contraindication for physical therapy techniques. * Legal incapacity or pregnancy. * Present a significant risk of self-harm or suicide requiring clinical management that takes precedence over study participation (this exclusion will be determined by the responsible medical team). Inclusion and Exclusion Criteria for Healthcare Professionals at Royo Villanova Hospital: Inclusion Criteria: * Be a healthcare professional (physician, nurse, physical therapist, occupational therapist, etc.) or non-healthcare staff member (nursing assistant, orderly, etc.) within the short-stay inpatient Psychiatry Department at Royo Villanova Hospital (Zaragoza). * Be actively employed under a single, permanent, or temporary employment contract throughout the duration of the physical therapy intervention implementation period. * Have provided written informed consent to participate in the study. Exclusion Criteria: * Professionals from the unit who were not actively employed under a single, permanent, or temporary employment contract throughout the entire duration of the physical therapy intervention implementation period. * Be on sick leave or parental leave during the period of qualitative data collection. * Have been transferred to another unit or healthcare center prior to the commencement of qualitative data collection.
What this study is about
In the sponsor’s own words, from the registry.
Major Depressive Disorder (MDD) significantly impacts quality of life and health status. Standard treatments include medical, psychological, and pharmacological approaches, with physical therapy often playing a less central role. This pilot study aims to investigate the potential benefits of incorporating a physical therapy program, based on therapeutic exercise and health education, within the management of MDD in a short-stay psychiatric unit.
This project will implement a physical therapy intervention consisting of twice-weekly sessions of active joint mobility exercises, strength training (body weight/elastic bands), balance exercises, and progressive muscle relaxation, integrated with health education on the benefits of physical activity for mental health and strategies for long-term adherence.
Adult patients (over 18 years) diagnosed with MDD, admitted to the short-stay psychiatry unit of Royo Villanova Hospital in Zaragoza and under regular medical, psychological, and pharmacological treatment, will be recruited for this study. All participants will receive the physical therapy program in addition to their standard care.
The main objective is to analyze the preliminary efficacy of a physical therapy intervention program based on health education and therapeutic exercise in improving quality of life and health status in adults with MDD during their stay in a short-stay psychiatric unit.
A secondary objective is to explore the perceptions of these patients and the healthcare professionals regarding the implementation of this multimodal treatment approach, including barriers and facilitators encountered.
Hypothesis: A physical therapy program integrating therapeutic exercise and health education is feasible and preliminarily effective in improving quality of life and health status in adults with MDD in a short-stay psychiatric unit and is perceived positively by both patients and healthcare professionals regarding its implementation.
Study sites(1)
Hospital Royo Villanova
Zaragoza, Aragon, Spain
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06983405. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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