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

NCT06983405 | Recruiting DMC

• 1 other identifier: 38/3/24-25
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder; Physical Therapy; Therapeutic Exercise; Health Education; Pilot Study; Quality of Life; Mental Health

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  Change in the score on the European quality of life questionnaire or EuroQol 5-Dimension 3-Level Spanish version questionnaire (EQ-5D-3L). The EQ-5D-3L health questionnaire is a questionnaire that can be self-administered or conducted through an interview, which allows for assessing the health status in relation to various patient dimensions (mobility, pain, mental health, etc.). It consists of 5 questions with 3 response options (good health = 1, some problems = 2, or health problem = 3), where the responses are coded and coefficients are applied according to the responses to obtain a reference value; and on the other hand, it consists of a 20-centimeter vertical visual analogue scale, with values from 0 = worst health state to 100 = best health state, where the patient indicates the current perceived health value. It is a validated tool widely used in health and research.

  From enrollment to the end of treatment at 3-6 weeks

Secondary Outcomes (4)

• Change in Severity of Depressive Symptoms

  From enrollment to the end of treatment at 3-6 weeks

• Change in Pain Intensity

  From enrollment to the end of treatment at 3-6 weeks

• Change in General Self-Efficacy

  From enrollment to the end of treatment at 3-6 weeks

• Healthcare Satisfaction Level

  Up to 6 weeks post-baseline - measured only at this time point

Other Outcomes (2)

• Focus Group Data: Qualitative Exploration of Patient Experiences and Perceptions in a Physical Therapy Program for Major Depressive Disorder

  Following completion of intervention and quantitative assessment up to 6 weeks

• Focus Group Data: Qualitative Exploration of Professional Perspectives on Implementing a Physical Therapy Program for Major Depressive Disorder

  Within 2 weeks of completion of the quantitative phase

Study Arms (1)

Physical Therapy Intervention Group

EXPERIMENTAL

Participants in this arm will receive a physical therapy program consisting of twice-weekly, 45-minute sessions of active joint mobility exercises, strength exercises (body weight/elastic bands), balance exercises, and progressive muscle relaxation, integrated with health education on the relationship between physical activity and mental health, benefits of exercise, strategies for increasing physical activity, self-assessment techniques, and community resources. This intervention will be delivered in addition to their standard medical, psychological, and pharmacological treatment for Major Depressive Disorder.

Other: Physical Therapy Program for MDD

Interventions

Physical Therapy Program for MDD OTHER

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.

Physical Therapy Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Universidad San Jorge: lead

Study Sites (1)

Hospital Royo Villanova

Zaragoza, Aragon, 50012, Spain

RECRUITING

Related Publications (1)

• Poveda-Lopez JL, Jimenez-Sanchez C, Lafuente-Ureta R, Marco-Gomez B, Villagrasa-Cantin A, Perez-Mansilla S, Guarch-Rubio M, Roy JF. Study protocol for a mixed-methods pilot of a physiotherapy plus education program for inpatients with major depressive disorder: Feasibility and preliminary effects. PLoS One. 2025 Nov 6;20(11):e0326012. doi: 10.1371/journal.pone.0326012. eCollection 2025.

  PMID: 41196855 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Health Education; Psychological Well-Being

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Personal Satisfaction

Study Officials

• Carolina Jiménez Sánchez, Dr

  Universidad San Jorge

  STUDY DIRECTOR

• José Lesmes Poveda López

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Jiménez Sánchez, Dr

CONTACT

+0034649612644; cjimenez@usj.es

José Lesmes Poveda López

CONTACT

+0034669946333; jlpoveda@usj.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot study employs a concurrent nested mixed-methods design. One group of participants will consist of adult patients admitted to the short-stay psychiatric unit diagnosed with Major Depressive Disorder. This patient group will participate in both the quantitative phase, involving pre- and post-intervention assessments of quality of life, depressive symptoms, and self-efficacy, and the qualitative phase, participating in focus groups to explore their experiences and perceptions. A separate group of participants will comprise healthcare professionals (including medical, nursing, and other allied health staff) working in the same psychiatric unit. This professional group will exclusively participate in the qualitative phase through focus groups to provide their perspectives on the implementation of the physical therapy intervention and its impact on patient management.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: December 2025-July 2026
• Access Criteria: Anonymized individual participant data that underlie the results in published manuscripts, including the study protocol and statistical analysis plan, will be made available to researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author of the publication. Access will be granted subject to approval by the research team and a data sharing agreement.

Locations

ES (1)