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.
Adults aged 18-60 years with a formal diagnosis of Major Depressive Disorder (MDD) based on DSM-5-TR or ICD-10 criteria.
A baseline score of ≥ 17 on the Hamilton Depression Rating Scale (HAM-D) is required to ensure a moderate-to-severe symptom profile
Patients with high suicidal ideation
Patients with a history of psychosis or bipolar disorder
Patient with physical contraindications to exercise (e.g., unstable cardiovascular disease).
Concurrent participation in other structured exercise/mindfulness trials.
Parallel
Aerobic exercise
Other interventionAerobic 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.
Mindful Breathing
Other interventionMindful 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.
Depressive symptom severity
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.
Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF)
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
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
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.
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