The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disorder in Saudi Arabia (MDD/AE/MB)
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
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:
- To determine the effect of aerobic exercise interventions on depressive symptoms of individuals diagnosed with MDD.
- To determine the effect of aerobic exercise interventions on health-related quality of life among individuals diagnosed with MDD.
- To determine the effect of mindful breathing exercises on depressive symptoms among individuals diagnosed with MDD.
- 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:
- 45 minutes of moderate AE (60-75% HRR);
- 15 minutes of guided mindful breathing (6 breaths/minute);
- a waitlist control receiving standard care. *Interventions will occur three times a week for 16 weeks.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Saad A Bin Muaythir, Master
- Número de teléfono: +966568200040
- Correo electrónico: u24122336@tuks.co.za
Ubicaciones de estudio
-
-
-
Al Kharj, Arabia Saudita
- Erada Hospital and Mental Health in Al Kharj
-
Contacto:
- Dawood F Aldawood
- Número de teléfono: +966505109089
- Correo electrónico: dfaldawood@moh.gov.sa
-
Riyadh, Arabia Saudita
- Erada complex and Mental Health in Riyadh
-
Contacto:
- Salwa M Abdulrahim
- Número de teléfono: +966508832162
- Correo electrónico: sabdulrahim@moh.gov.sa
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Aerobic Exercise (AE)
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).
|
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.
Otros nombres:
|
|
Experimental: Mindful Breathing (MB)
The MB protocol focuses on "Top-Down" emotional regulation and "Bottom-Up" autonomic stabilisation.
|
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.
Otros nombres:
|
|
Otro: Control Group (Standard Care) Standard Treatment
Participants will continue their prescribed pharmacological treatment and any existing psychotherapy and physiotherapy sessions.
|
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.
Otros nombres:
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Depressive symptom severity
Periodo de tiempo: 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. |
Baseline, Week 4,8, and a 16-week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF)
Periodo de tiempo: 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
|
WHOQOL-BREF: baseline and week 16.
|
|
Quality of life (QoL)2 : Anxiety Symptoms
Periodo de tiempo: 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.
|
Baseline, Week 4,8, and a 16-week
|
|
Quality of life (QoL) 3: Sleep Quality
Periodo de tiempo: 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.
|
Baseline, Week 4, Week 8, and Week 16.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Saad Bin Muaythir, Master
Publicaciones y enlaces útiles
Publicaciones Generales
- Elfil M, Negida A. Sampling methods in Clinical Research; an Educational Review. Emerg (Tehran). 2017;5(1):e52. Epub 2017 Jan 14.
- 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.
- 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.
- 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.
- 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.
- 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.
- 6. Muaythir SB, Bello B, Magida N. Effect of Aerobic Exercise on Depression Symptoms and Quality of Life in Patients with Major Depressive Disorder: A Systematic Review and Meta-Analysis
- 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.
- Jenkins DG, Quintana-Ascencio PF. A solution to minimum sample size for regressions. PLoS One. 2020 Feb 21;15(2):e0229345. doi: 10.1371/journal.pone.0229345. eCollection 2020.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 680/2024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .