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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad San Jorge

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Physical Therapy Program for MDD

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Physical Therapy Intervention GroupExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Change in Severity of Depressive Symptoms

Change in the score on the Montgomery-Asberg Depression Rating Scale (MADRS) Spanish version. It is a scale used clinically for the detection and severity assessment of major depressive disorder. It consists of 10 questions administered to the interviewee regarding cognitive and affective/emotional symptoms, with response values ranging from 0 to 6 (0 = lowest level of symptomatology and 6 = highest level of symptomatology). Its interpretation is as follows: 0-6 points, no depression; 7-19 points, mild depression; 20-34 points, moderate depression; and 35-60 points, severe depression.

Time frame
From enrollment to the end of treatment at 3-6 weeks
2

Change in Pain Intensity

Change in the score on the Numerical Rating Scale (NRS). The NRS scale for pain assessment is a scale that measures the intensity of pain experienced by the patient. It is a numerical rating scale where the patient is asked to rate their pain between 0 and 10. The reported values are classified as follows: no pain = 0; mild pain = 1,2; moderate pain = 3-5; severe pain = 6-8; unbearable pain = 9-10.

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

Change in General Self-Efficacy

Change in the score on the General Self-Efficacy Scale (GSE) Spanish version. The Spanish version of the General Self-efficacy Scale consists of a 10-item questionnaire that measures an individual's perception of their own abilities to manage their life in stressful situations. For each question, the respondent answers using a Likert scale where the response is scored as 1 = completely disagree and 5 = completely agree. A score between 27 and 38 points is considered an average level of self-efficacy. Higher scores indicate a greater perceived self-efficacy.

Time frame
From enrollment to the end of treatment at 3-6 weeks
4

Healthcare Satisfaction Level

Score on the Health Care Satisfaction Survey for People with Chronic Illness (GCPC-UN-ESU). It contains 19 items with 4 dimensions: care, health education, the quality of the service provided, and the level of loyalty to the service. Each item is scored between 1 (not at all satisfied) and 5 (extremely satisfied). Higher scores indicate greater satisfaction.

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

Other outcomes

1

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

This qualitative outcome measure will use focus groups to explore the experiences and perceptions of patients with major depressive disorder participating in a physical therapy program. Patient narratives will detail their experience with the illness, their condition management strategies, and the barriers and facilitators encountered during the program. Data, collected via audio recordings and field notes from trained researchers, will undergo thematic analysis. Anticipated themes include experiences with physical therapy, perceived impact on symptoms, coping strategies, support systems, adherence factors, facilitators to recovery, and suggestions for program improvement. Qualitative findings will provide context to quantitative results.

Time frame
Following completion of intervention and quantitative assessment up to 6 weeks
2

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

This qualitative outcome measure will use focus groups to explore the experiences and perspectives of healthcare professionals involved in a physical therapy program for patients with major depressive disorder. Professional narratives will detail their perspectives on managing patients with the illness, their observations of patient condition management strategies, and the barriers and facilitators they encountered during the program's implementation. Data, collected via audio recordings and field notes from trained researchers, will undergo thematic analysis. Anticipated themes include experiences with implementing the physical therapy program, perceived impact on patients, interprofessional collaboration, resource utilization, adherence factors from the professionals' point of view, facilitators to program delivery, and suggestions for program improvement. Qualitative findings will provide context to quantitative results.

Time frame
Within 2 weeks of completion of the quantitative phase

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