The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disord… (NCT07625163) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disorder in Saudi Arabia
Saudi Arabia60 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines aerobic exercise and mindful breathing as treatments for major depressive disorder — how do these approaches compare to the medication or therapy you might already be recommending for me?
2Since the trial hasn't started recruiting yet, what would the realistic timeline look like before I could even join, and is it worth waiting or should we pursue another treatment path now?
3The study is being conducted in Saudi Arabia — given that location, is this something I could realistically participate in, and would there be any remote or in-person requirements that could affect my daily life?
4Because this trial is listed as Phase NA, meaning it's not a traditional drug trial, what do we already know about the safety and effectiveness of aerobic exercise and mindful breathing for people with MDD like mine?
5If I were to participate in a study like this that focuses on exercise and breathing rather than medication, what happens to my treatment if my symptoms get significantly worse during the trial period?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.