Clinical trial NCT06983405: Physical Therapy for Depression Quality of Life (Pilot Study Protocol)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: Major Depressive Disorder
Physical Therapy
Therapeutic Exercise
Health Education
Pilot Study
Quality of Life
Mental Health
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: This project employs a concurrent nested mixed-methods pilot study with quantitative dominance to evaluate a physical therapy intervention program for adults with Major Depressive Disorder (MDD) within a short-stay psychiatric unit. The quantitative component utilizes a quasi-experimental pre-post design, while the qualitative aspect employs a narrative design through focus groups.

Intervention Protocol:

The physical therapy intervention will be delivered by trained physical therapists in twice-weekly, 45-minute sessions tailored to the participant's length of hospital stay (anticipated 3-6 weeks). Each session will systematically incorporate:

Active Joint Mobility: A series of gentle, controlled movements targeting major joints to maintain or improve their range of motion.

Progressive Strength Training: Low-to-moderate intensity exercises utilizing the participant's own body weight and progressive resistance elastic bands, focusing on key muscle groups.

Balance Enhancement: A structured set of exercises designed to improve stability and reduce the risk of falls, with the difficulty level adapted to each individual's functional capacity.

Relaxation Techniques: Progressive muscle relaxation exercises will be implemented at the conclusion of each session to facilitate physical and mental relaxation.

Integrated Health Education:

Concurrent with the exercise program, participants will receive brief, integrated health education. This component will cover:

The physiological and psychological links between physical activity and mental well-being.

The specific benefits of the exercises within the program concerning mood, physical function, and overall quality of life.

Practical strategies for incorporating and maintaining physical activity as part of their lifestyle post-discharge.

Methods for self-monitoring physical activity levels and mood changes to enhance self-efficacy.

Information regarding available community resources and physical activity programs that participants can access after leaving the hospital.

Qualitative Data Collection Protocol:

Separate focus groups will be conducted with:

Patients with MDD: These discussions will explore their lived experiences with MDD, their perceptions of the overall management of their condition during hospitalization, and their specific experiences with the physical therapy intervention program, including any perceived barriers and facilitators to participation and benefit.

Healthcare Professionals: Focus groups with the multidisciplinary team (including medical, nursing, and other allied health staff) from the short-stay psychiatry unit will focus on their perspectives regarding the integration of physical therapy into the standard care pathway for patients with MDD, their observations of patient engagement and response to the intervention, and any perceived barriers and facilitators to its implementation within the clinical setting.

Focus groups will be guided by semi-structured question guides, audio-recorded with informed consent, and transcribed verbatim. Data collection will continue until thematic saturation is achieved. Thematic content analysis will be employed to identify key patterns and insights from the narratives.

Data Analysis Approach:

The quantitative data, collected at baseline and post-intervention, will be analyzed using appropriate statistical methods for pre-post comparisons in a single group design. Descriptive statistics will summarize the sample characteristics and outcome measures at each time point. Inferential statistics will be used to assess the magnitude and statistical significance of changes in the primary and secondary outcome measures following the intervention.

The qualitative data from the focus groups will be analyzed using thematic content analysis. Transcripts will be independently coded by two researchers, with codes grouped into subcategories and subsequently into overarching themes through a process of iterative refinement and consensus. Measures to ensure the trustworthiness of the qualitative data, such as data and investigator triangulation, will be employed.

Finally, a mixed-methods approach will be used to integrate the quantitative findings on the program's potential efficacy with the rich contextual data obtained from the qualitative component, providing a more comprehensive understanding of the intervention's impact and feasibility.

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.

Primary outcomes:
measure: Change in Quality of Life
timeFrame: From enrollment to the end of treatment at 3-6 weeks
Secondary outcomes:
measure: Change in Severity of Depressive Symptoms
timeFrame: From enrollment to the end of treatment at 3-6 weeks
measure: Change in Pain Intensity
timeFrame: From enrollment to the end of treatment at 3-6 weeks
measure: Change in General Self-Efficacy
timeFrame: From enrollment to the end of treatment at 3-6 weeks
measure: Healthcare Satisfaction Level
timeFrame: Up to 6 weeks post-baseline - measured only at this time point
Other outcomes:
measure: Focus Group Data: Qualitative Exploration of Patient Experiences and Perceptions in a Physical Therapy Program for Major Depressive Disorder
timeFrame: Following completion of intervention and quantitative assessment up to 6 weeks
measure: Focus Group Data: Qualitative Exploration of Professional Perspectives on Implementing a Physical Therapy Program for Major Depressive Disorder
timeFrame: Within 2 weeks of completion of the quantitative phase
Locations:
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
state: Aragón
Study officials:
affiliation: Universidad San Jorge
name: Carolina Jiménez Sánchez, Dr
role: STUDY_DIRECTOR
affiliation: Universidad San Jorge
name: José Lesmes Poveda López
role: PRINCIPAL_INVESTIGATOR
References: