Alleviating Stress by Mobile Application' for Depression (NCT05312203) | Clinical Trial Compass
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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 range19 Years – 65 Years
SexALL
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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);
✕. 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;
What they're measuring
1
Change in Depression, Anxiety and Stress Scale (DASS-21)