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

ClinicalTrials.gov ID

NCT07625163

Lead Sponsor

University of PretoriaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Jun 4, 2026Actual

Start Date

Jun 15, 2026Estimated

Primary Completion Date

Oct 14, 2026Estimated

Completion Date

Nov 14, 2026Estimated

Official Title

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

Brief Summary

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.

Detailed Description

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.

• Major Depressive Disorder (MDD)

• Aerobic exercise
• Mindful Breathing

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University of PretoriaOTHER

sabdulrahim@moh.gov.sa+966508832162

• Breathing Exercises on Depression in Postmenopausal Women

  NCT06741384

  Not yet recruitingInterventionalNot ApplicableUpdated Dec 20, 2024
• Group CBT and Exercise in Management of Depression

  NCT03731728

  TerminatedInterventionalNot ApplicableUpdated Nov 12, 2020
• Effectiveness of Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Study

  NCT04403373

  CompletedInterventionalNot ApplicableUpdated May 4, 2021
• Effect of Aerobic Exercise on Biomarkers in Depression

  NCT07062783

  CompletedInterventionalNot ApplicableUpdated Aug 5, 2026
• Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression

  NCT02176408

  CompletedInterventionalNot ApplicableUpdated Sep 10, 2019
• Mindfulness to Mitigate the Effect of Anxiety-depression-fear in Chronic Obstructive Pulmonary Disease (COPD)

  NCT03385317

  WithdrawnInterventionalNot ApplicableUpdated Dec 28, 2017