An interventional study of Aerobic exercise and Mindful Breathing in Major Depressive Disorder (MDD), sponsored by University of Pretoria. Not yet recruiting at 2 sites in Saudi Arabia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by University of Pretoria · Not applicable, Interventional, and Treatment
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:
Participants will be randomized into three groups:
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 60 is below the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →University of Pretoria is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The AE protocol is designed to achieve the moderate-intensity threshold (SMD = -0.91), which has been identified as the most effective for symptom reduction (16). * Warm-up: 5-10 minutes of low-intensity walking and dynamic stretching. * Core Phase: 30 minutes of continuous aerobic activity (walking or Stationary Cycling). * Intensity Monitoring: Heart rate (HR) will be monitored using wearable sensors. Target intensity is set at 60-75% of the Heart Rate Reserve (HRR) or a Rating of Perceived Exertion (RPE) of 12-14 on the Borg Scale. * Cool-down: 5 minutes of slow walking and static stretching.
Other: Aerobic exercise
The MB protocol focuses on "Top-Down" emotional regulation and "Bottom-Up" autonomic stabilisation. * Technique: Participants will be taught Diaphragmatic Resonant Breathing. This involves inhaling through the nose for four (4) seconds and exhaling slowly for six (6) seconds (approximately 6 deep breaths per minute). * Mindfulness Component: During the breathing, participants are instructed to maintain "non-judgmental awareness," acknowledging stray thoughts and gently returning focus to the sensation of air entering and leaving the body. * Duration: 15 minutes per session, conducted in a seated, comfortable position with eyes closed or a soft gaze.
Other: Mindful Breathing
Participants will continue their prescribed pharmacological treatment and any existing psychotherapy and physiotherapy sessions.
Other: Aerobic exercise · Other: Mindful Breathing
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.
Also known as: walking, cardiovascular exercise
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.
Also known as: diaphragmatic breathing, deep breathing
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.
Time frame: Baseline, Week 4,8, and a 16-week
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
Time frame: WHOQOL-BREF: baseline and week 16.
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.
Time frame: Baseline, Week 4,8, and a 16-week
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.
Time frame: Baseline, Week 4, Week 8, and Week 16.
Plan to share: No — Indirect identifiers will be used through coded participant IDs. Direct identifiers will be stored separately from research data. Use participant codes on all study forms; store consent forms separately; keep electronic data on password-protected/encrypted devices or servers; keep paper CRFs in locked cabinets; restrict access to PI and authorized research staff only.
Start is estimated for Jun 2026; primary completion for Oct 2026, 3 months later.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 3 months is below that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Pretoria