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RECRUITING

NCT06983405

Physical Therapy for Depression Quality of Life (Pilot Study Protocol)

Sponsor: Universidad San Jorge

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-01

Completion Date

2026-07

Last Updated

2026-01-09

Healthy Volunteers

Conditions

Major Depressive Disorder (MDD)

Interventions

OTHER

Physical Therapy Program for MDD

PT program for hospitalized adults with MDD: twice-weekly, 45-min sessions integrating: 1) Active joint mobility (gentle movements for ROM). 2) Progressive strength (bodyweight/bands, low-mod intensity, major muscles). 3) Balance (stability exercises, adapted difficulty). 4) Progressive muscle relaxation (end of session). Includes health education: exercise \& mental health link (biological/psychological mechanisms), benefits of each exercise type (mood, function, QoL), post-discharge activity strategies, self-assessment, community resources in Zaragoza. Delivered by trained PTs, adaptable to individual needs.

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.

Locations (1)

Hospital Royo Villanova

Zaragoza, Aragon, Spain