臨床研究等提出・公開システム

Preliminary study on Just-in-time intervention using wearable devices aimed at improving sleep / waking rhythm against mood disorder

Preliminary research on just-in-time intervention (Preliminary research on just-in-time intervention)

Iwata Nakao

Fujita Health University School of Medicine

1-98 Dengakugakubo.kutukake-cho.Toyoake.Aichi

nakao@fujita-hu.ac.jp

Ono Yoshiaki

Fujita Health University School of Medicine

1-98 Dengakugakubo.kutukake-cho.Toyoake.Aichi

+81-562-93-9250

yoshiono@fujita-hu.ac.jp

Recruiting

June. 17, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

health services research

1. Patients who have obtained their written consent by their own free will, after receiving sufficient explanation, to participate in this study
2. Patients between 20 and 75 years of age at the time of obtaining consent (for undergraduates or adult adults)
3. Mild to moderate depression, or outpatients diagnosed with mood disorders (major depressive disorder, bipolar disorder [types 1 and 2], dysthymia) based on DSM-5, or Also includes remission status
4. In terms of medical interviews, the average sleep time on weekdays is less than 6 hours, or the actual arrival time is later than half the week, including weekends, that is later than the desired sleep time for the patient
5. Any other treatment content (drugs etc.) currently in use
6. I have a smartphone and am used to using it

1. Patients with metal and rubber allergies when wearing devices
2. Patients who are in the acute phase of depression and who the attending physician should center on intervention for mental symptoms
3. Patients with obvious lupus
4. Patients with psychophysiological insomnia (Patients who increase anxiety for sleep before sleep onset)
5. Patients who can not agree not to browse mobile apps while driving
6. Other patients judged to be inappropriate by the Principal Investigator or Investigator

Both

Bipolar disorder, Depression, Dysthymia

We connect messages of behavioral interventions related to sleep hygiene with feedback of the previous day's sleep data with Just-in-Time method (determining the presence or absence of intervention based on the data of the previous day's sleep and awakening) for mood disorder patients using wearable devices Send to your smartphone.

Time-lapse change of mean value every two weeks (change from baseline) about sleep onset time measured by wearable device, including baseline period (2 weeks before intervention) and 6 weeks JITAI intervention period

For the following evaluation, change over time of mean value every two weeks (change from baseline) including baseline period (2 weeks before intervention) and 6 weeks of JITAI intervention period
Daily wake time (next morning) and sleep time measured by wearable device
Daily (next morning) health related indicators entered in the app (5 grades by Likert scale)
Morning wake up
Vigor ( There is a possibility of change by application specifications)
The difference between the day with and without the intervention determined by JITAI and the influence of the passage of time on the following evaluations measured daily:
Daily sleep onset time, wake time (next morning), sleep time measured by wearable device
Daily (next morning) health related indicators entered in the app (5 grades by Likert scale)
Morning wake up
Vigor (There is a possibility of change by application specifications)
Change over time during the intervention period of the following evaluation performed every two weeks
Sleeping time, awakening time, halfway awakening, sleeping time according to the sleep log written by the patient
Self-administered evaluation by patients
Beck Depression Rating Scale (BDI)
Ostberg's morning-night scale (MEQ)
Munich Chronotype Questionnaire (MCTQ)
Epworth Sleepiness Rating Scale (ESS)
Usability of wearable device (free description)
Doctor's evaluation
Clinical Comprehensive Impression Scale-Degree of Improvement (CGI-I)
Correlation of daily sleep onset time, wake time, and sleep time with the A.M.I Actigraph simultaneously installed in the baseline period

+81-562-93-2865

May. 16, 2019

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