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The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disorder in Saudi Arabia (MDD/AE/MB)

1. Juni 2026 aktualisiert von: Saad Bin Muaythir, University of Pretoria

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:

  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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Saudi-Arabien
      • Al Kharj, Saudi-Arabien
        • Erada Hospital and Mental Health in Al Kharj
        • Kontakt:
      • Riyadh, Saudi-Arabien
        • Erada complex and Mental Health in Riyadh
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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).

  • 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.
Sonstiges: 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.
Andere Namen:
  • gehen
  • cardiovascular exercise
Experimental: Mindful Breathing (MB)

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.
Sonstiges: 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 response.
Andere Namen:
  • tiefes Atmen
  • Zwerchfellatmung
Sonstiges: Control Group (Standard Care) Standard Treatment
Participants will continue their prescribed pharmacological treatment and any existing psychotherapy and physiotherapy sessions.
Sonstiges: 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.
Andere Namen:
  • gehen
  • cardiovascular exercise
Sonstiges: 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 response.
Andere Namen:
  • tiefes Atmen
  • Zwerchfellatmung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depressive symptom severity
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Pretoria

Ermittler

  • Hauptermittler: Saad Bin Muaythir, Master

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juni 2026

Primärer Abschluss (Geschätzt)

14. Oktober 2026

Studienabschluss (Geschätzt)

14. November 2026

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

4. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 680/2024

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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