The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disorder in Saudi Arabia

Официальное название

The Effects of Aerobic Exercise and Mindful Breathing on Symptom Severity and Quality of Life in Individuals With Major Depressive Disorder in Saudi Arabia: A Randomised Clinical Trial Protocol

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Aerobic 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.
• Другое Mindful 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 re

Первичные конечные точки

• Depressive symptom severity [Срок оценки: Baseline, Week 4,8, and a 16-week]

Вторичные конечные точки (3)

• Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF) [Срок оценки: WHOQOL-BREF: baseline and week 16.]
• Quality of life (QoL)2 : Anxiety Symptoms [Срок оценки: Baseline, Week 4,8, and a 16-week]
• Quality of life (QoL) 3: Sleep Quality [Срок оценки: Baseline, Week 4, Week 8, and Week 16.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 2 центра

• Erada Hospital and Mental Health in Al Kharj — Al Kharj
• Erada complex and Mental Health in Riyadh — Riyadh

Публикации

• 1. WHO. Depressive disorder (depression): World Health Organization; 2025 [Available from: https://www.who.int/news-room/fact-sheets/detail/depression.
• GBD 2023 Demographics Collaborators. Global age-sex-specific all-cause mortality and life expectancy estimates for 204 countries and territories and 660 subnational locations, 1950-2023: a demographic analysis for the Global Burden of Disease Study 2023. Lancet. 2025 Oct 18;406(10513):1731-1810. doi: 10.1016/S0140-6736(25)01330-3. Epub 2025 Oct 12. PMID 41092927
• Alnaim MA, Alghamdi AH, Aljawair MR, Alhadi FA, Alomair AM, Alsaad A. Depression among Saudi international university students and its associated risk factors. BMC Public Health. 2024 Nov 11;24(1):3101. doi: 10.1186/s12889-024-20565-y. PMID 39523315
• Pigott HE, Kim T, Xu C, Kirsch I, Amsterdam J. What are the treatment remission, response and extent of improvement rates after up to four trials of antidepressant therapies in real-world depressed patients? A reanalysis of the STAR*D study's patient-level data with fidelity to the original research protocol. BMJ Open. 2023 Jul 25;13(7):e063095. doi: 10.1136/bmjopen-2022-063095. PMID 37491091
• Romero Garavito A, Diaz Martinez V, Juarez Cortes E, Negrete Diaz JV, Montilla Rodriguez LM. Impact of physical exercise on the regulation of brain-derived neurotrophic factor in people with neurodegenerative diseases. Front Neurol. 2025 Jan 28;15:1505879. doi: 10.3389/fneur.2024.1505879. eCollection 2024. PMID 39935805
• Komariah M, Ibrahim K, Pahria T, Rahayuwati L, Somantri I. Effect of Mindfulness Breathing Meditation on Depression, Anxiety, and Stress: A Randomized Controlled Trial among University Students. Healthcare (Basel). 2022 Dec 22;11(1):26. doi: 10.3390/healthcare11010026. PMID 36611488
• Bin Muaythir S, Bello B, Mshunqane N, Ramano E, Magida N. Effect of Aerobic exercise on depression symptoms and quality of life in Patients with major depressive disorder: a systematic review Protocol. BMJ Open. 2026 Jun 10;16(6):e112841. doi: 10.1136/bmjopen-2025-112841. PMID 42270109
• Marquez DX, Aguinaga S, Vasquez PM, Conroy DE, Erickson KI, Hillman C, Stillman CM, Ballard RM, Sheppard BB, Petruzzello SJ, King AC, Powell KE. A systematic review of physical activity and quality of life and well-being. Transl Behav Med. 2020 Oct 12;10(5):1098-1109. doi: 10.1093/tbm/ibz198. PMID 33044541

Идентификаторы

NCT: NCT07625163 · 680/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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