NCT06983405Recruiting
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 24 Apr 2025
- Start date
- 1 Sept 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Universidad San Jorge
- Diseases
- Depression
- NCT number
- NCT06983405
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Sept 2025 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of a physical or mental dysfunction or disability that constitutes a total or partial contraindication for physical therapy techniques.
- 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.
- Have been transferred to another unit or healthcare center prior to the commencement of qualitative data collection.
Other illness
- Presence of a comorbid physical or mental illness whose clinical characteristics and/or severity impede comprehension and/or adherence to the physical therapy interventions.
Other
- 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:
- Be on sick leave or parental leave during the period of qualitative data collection.
Who the study is looking for
- 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.
- 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.
Criteria the registry did not label
- Inclusion and Exclusion Criteria for Patients with Major Depressive Disorder (MDD):
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Royo Villanova Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.