Fact CheckerSign in

NCT07625163Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
27 May 2026
Start date
15 Jun 2026
Primary completion date
14 Oct 2026
Lead sponsor
University of Pretoria
Diseases
Depression
NCT number
NCT07625163

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 15 Jun 2026 to the primary completion date, 14 Oct 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation in other structured exercise/mindfulness trials.

Other illness

  • Patients with a history of psychosis or bipolar disorder
  • Patient with physical contraindications to exercise (e.g., unstable cardiovascular disease).

Other

  • Patients with high suicidal ideation

Who the study is looking for

  • 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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Erada Hospital and Mental Health in Al Kharj
Coordinator of this site? Confirm its status
Al KharjSaudi ArabiaUnknown status
Erada complex and Mental Health in Riyadh
Coordinator of this site? Confirm its status
RiyadhSaudi ArabiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.