Major Depressive Disorder (MDD)
Conditions
Keywords
Major Depressive Disorder, Aerobic Exercise, Mindful Breathing, Quality of Life, Saudi Arabia
Brief summary
The goal of this Randomized Clinical Trial is to evaluate the effectiveness of aerobic exercise (AE) and mindful breathing (MB) on depressive symptom severity and quality of life (QoL), in adults with MDD. The main question is: Does aerobic exercise and mindful breathing delivery reduce depressive symptom severity and improve quality of life more effectively than standard psychiatric care? The aims to answer are: 1. To determine the effect of aerobic exercise interventions on depressive symptoms of individuals diagnosed with MDD. 2. To determine the effect of aerobic exercise interventions on health-related quality of life among individuals diagnosed with MDD. 3. To determine the effect of mindful breathing exercises on depressive symptoms among individuals diagnosed with MDD. 4. To determine the effect of the mindful breathing exercise intervention on quality of life amongst individuals diagnosed with MDD. Participants will be randomized into three groups: 1. 45 minutes of moderate AE (60-75% HRR); 2. 15 minutes of guided mindful breathing (6 breaths/minute); 3. a waitlist control receiving standard care. \*Interventions will occur three times a week for 16 weeks.
Detailed description
Major Depressive Disorder (MDD) is a leading cause of global disability, with many patients showing suboptimal responses to conventional pharmacological treatments. Evidence suggests that aerobic exercise (AE) and mindful breathing (MB) can serve as powerful non-pharmacological modulators of the central and autonomic nervous systems. This protocol outlines a randomized clinical trial (RCT) to evaluate the individual and synergistic effects of these interventions in a Saudi Arabian clinical population. Major Depressive Disorder (MDD) is no longer viewed merely as a psychological condition but as a systemic, multi-faceted public health crisis. According to the World Health Organization and the latest Global Burden of Disease (GBD) analysis, MDD is a primary driver of global disability, defined by persistent feelings of sadness, anhedonia, sleep disturbances, and diminished capacity for daily functioning . Globally, it affects more than 280 million people. In Saudi Arabia, the rising prevalence of MDD necessitates a shift toward "Integrative Psychiatry," where lifestyle medicine serves as a core pillar. Despite the availability of pharmacological and psychotherapeutic treatments, many individuals experience suboptimal outcomes, relapse, or treatment resistance, with the STAR\*D study highlighting that only about one-third of patients achieve full remission after their first course of antidepressant medication . Furthermore, the side effects of conventional medications, such as weight gain and metabolic syndrome, often lead to premature discontinuation. While the individual antidepressant effects of exercise and mindful breathing are well-documented, significant gaps remain. Existing literature indicates that AE "primes" the brain by increasing neuroplasticity and reward processing. Mindful breathing, conversely, stabilizes the autonomic nervous system and reduces anxiety. Combining these two low-cost, non-pharmacological interventions may provide a superior "biopsychosocial" approach to MDD recovery that neither could achieve alone. Modern psychiatry recognizes that a patient can be "less depressed" while still having a poor Quality of Life (QoL). Exercise is uniquely positioned to improve QoL because its benefits are "transdiagnostic", improving physical vitality, sleep quality, and social engagement simultaneously. and a baseline Hamilton Depression Rating Scale (HAM-D) score ≥ 17.
Interventions
OTHERAerobic exercise
Aerobic or cardiovascular exercise is characterized by activities that engage large muscle groups, including walking, jogging, or cycling. Regular aerobic exercise can improve cardiovascular health, endurance, and overall fitness.
OTHERMindful Breathing
Mindful breathing can include diaphragmatic breathing, deep breathing, and controlled breathing techniques, which focus on regulating and optimizing the process of inhalation and exhalation. These techniques enhance respiratory function, increase lung capacity, and promote relaxation by activating the parasympathetic nervous system. Therefore, they have been used in various therapeutic contexts to manage stress, anxiety, and mood disorders, including MDD, by regulating emotions and the stress response.
Sponsors
University of Pretoria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Group 1: Aerobic Exercise (AE) Administration The AE protocol is designed to achieve the moderate-intensity threshold * Warm-up: 5-10 minutes of low-intensity walking. * Core Phase: 30 minutes of continuous aerobic activity (walking). * Cool-down: 5 minutes of slow walking and static stretching. Group II: Mindful Breathing (MB) Administration * Technique: Participants will be taught Diaphragmatic Resonant Breathing. This involves inhaling through the nose for 4 seconds and exhaling slowly for 6 seconds (approximately 6 breaths per minute). * Duration: 15 minutes per session, conducted in a seated, comfortable position with eyes closed or a soft gaze. Group III: Control Group (Standard Care) : Participants will continue their prescribed pharmacological treatment and any existing psychotherapy or physiotherapy sessions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18-60 years with a formal diagnosis of Major Depressive Disorder (MDD) based on DSM-5-TR or ICD-10 criteria. 2. A baseline score of ≥ 17 on the Hamilton Depression Rating Scale (HAM-D) is required to ensure a moderate-to-severe symptom profile
Exclusion criteria
1. Patients with high suicidal ideation 2. Patients with a history of psychosis or bipolar disorder 3. Patient with physical contraindications to exercise (e.g., unstable cardiovascular disease). 4. Concurrent participation in other structured exercise/mindfulness trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptom severity | Baseline, Week 4,8, and a 16-week | Depressive symptom severity will be assessed using the Hamilton Depression Rating Scale (HAM-D), with total scores ranging from 0 to 52. Higher scores indicate more severe depressive symptoms. For MDD, a baseline Hamilton Depression Rating Scale (HAM-D) score of ≥ 17 is required. Reduction in Hamilton Depression Rating Scale (HAM-D) scores is the primary outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF) | WHOQOL-BREF: baseline and week 16. | Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), which generates domain scores transformed to a scale ranging from 0 to 100. Higher scores indicate a better quality of life |
| Quality of life (QoL)2 : Anxiety Symptoms | Baseline, Week 4,8, and a 16-week | Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire with total scores ranging from 0 to 63. Higher scores indicate greater anxiety severity. |
| Quality of life (QoL) 3: Sleep Quality | Baseline, Week 4, Week 8, and Week 16. | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality. |
Countries
Saudi Arabia
Contacts
CONTACTSaad A Bin Muaythir, Master
PRINCIPAL_INVESTIGATORSaad Bin Muaythir, Master
Outcome results
None listed