Alleviating Stress by Mobile Application' for Depression (NCT05312203) | Clinical Trial Compass
UnknownNot Applicable
Alleviating Stress by Mobile Application' for Depression
South Korea42 participantsStarted 2022-05-15
Plain-language summary
This study is a single-blind, multicenter, randomized, controlled crossover trial. The App, developed in South Korea, is an application that provides integrated interventions for stress reduction for the general population. The App provides three contents based on MBSR, CBT, and relaxation sounds that are known to be effective in stress reduction ("Meditation category", "Cognitive approach", and "Relaxation Sound", respectively). Participants (n = 215) recruited via medical practitioner referral will be randomized to App first group (fAPP) or a waitlist crossover group (dAPP). Inclusion criteria are age 19-65; diagnosed with mild to moderate major depressive disorders (Score of 7-24 on the Hamilton Rating Scale for Depression); Stable medication for 28 days prior to study participation. The study was conducted over eight weeks, the fAPP group used The App for the first four weeks and the dAPP group for the next four weeks, and during all study periods, the participants received usual pharmacological treatment. Primary outcome measures are the Depression Anxiety Stress Scale-21. The analysis will use mixed-model repeated measures.
Who can participate
Age range
19 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults between the ages of 19 and 65;
. Diagnosed with mild to moderate major depressive disorders in an expert interview evaluation according to the DSM-IV diagnostic criteria (Score of 7-24 on the Hamilton Rating Scale for Depression \[HAM-D\]);
. Stable medication for 28 days prior to study participation;
. Informed consent and voluntary participation.
Exclusion criteria
. Hard to use smart phone or unable to independently use Application;
. Diagnosed with severe major depressive disorder in an expert interview evaluation according to the DSM-5 diagnostic criteria (score of 25 or more on HAM-D);
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Change in Depression, Anxiety and Stress Scale (DASS-21)
. Severe mental disorders (current or in the past), including Major depressive disorder with psychotic features, bipolar affective disorder, personality disorder, obsessive compulsive disorder, autism spectrum disorder, substance use disorder;
. History of brain injury, epileptic seizures, intellectual disability, or cognitive disorders;
. History of severe physical disorders, including cancer, tuberculosis, severe cardiovascular disease, etc.
. Individuals participating in other cognitive behavioral therapy or activities related to stress relief