Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT06983405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Therapy for Depression Quality of Life (Pilot Study Protocol)
Sponsor:
Universidad San Jorge
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTEduQoL-MDD
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: