None listed
Conditions
Interventions
Medical Device : Participants were asked to perform meditation using the device twice a day for a total of 2 weeks, 14days, for 12minutes per session. The measured bio-signals are linked to the Applic
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants were between 19 and 65 years old with psychological stress and subclinical symptoms of depression or anxiety. Enrolled participants underwent screening tests at the first visit, and we included those who met both of the following criteria: (1) Perceived Stress Scale (PSS) score = 14; and (2) either Beck Depression Inventory-II (BDI-II) score = 20 or Insomnia Severity Index (ISI) score = 8.
Exclusion criteria
Exclusion criteria: Exclusion criteria were as follows: (1) psychiatric disorders including mood disorders, anxiety disorders, and psychotic disorders; (2) any other sleep disorders such as insomnia disorder, sleep apnea or restless legs syndrome based on the diagnostic criteria of DSM-5 or International Classification of Sleep Disorders (ICSD)-3; (3) medical illness such as cerebrovascular disease, heart disease, malignancy, lung disease, endocrine disorders, infectious diseases and impaired renal or hepatic function; (4) a history of neurological abnormalities such as head trauma or convulsive disease; (5) those with chronic pain; (6) those who are pregnant, lactating, or planning to become pregnant during this study; (7) those who have received cognitive behavioral therapy, biofeedback, neurofeedback, or meditation therapy within 1 year; (8) those who have taken steroids or hormone therapy (corticosteroids, oral contraceptives, sex hormone injections) within the last 4 weeks (9) any acute severe stressful life events (death of family members/ divorce/ separation/ debt/ run away/ business failure/ serious illness/ marriage, etc) within four weeks prior to study; (10) use of any psychiatric drugs such as sleeping pills, antidepressants, anxiolytics, and stimulants within 4 weeks prior to study; (11) shift work of jet lag within 2 weeks prior to study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| K-BDI-II(Korea Beck Depression Inventory), PSS (Percieved Stress Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| qEEG(quantitative electroencephalography), HRV(Heart Rate Variability), serum cortisol, ACTH(adrenocorticotrophic hormone), IL-6(Interleukin-6), TNF-a(Tumor Necrosis Factor-alpha), ISI(Insomnia Severity Index), PSQI(Pittsburgh Sleep Quality Index), STAI(State Trait Anxiety Inventory), QOL BREF(WHO Quality of Life Scale abbreviateed version) | — |
Countries
Korea, Republic of
Contacts
Public ContactEunyoung Lee
VHS Medical Center
Outcome results
None listed