Randomized controlled trial of a cognitive behavioral therapy application for insomnia (IIIP MED: Sleepy Med)
- Conditions
- Insomnia disorderinsomnia disorderInsomnia Disorder
- Registration Number
- JPRN-jRCT2032230353
- Lead Sponsor
- Shimizu Eiji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Screening step 1
(1) Age 18 years and older
(2) Meets DSM-5 diagnostic criteria for insomnia disorder
(3) ISI score >= 11
(4) Has internet access at home and can operate a smartphone or a tablet
Screening step 2
(1) Patients with subjective sleep onset latency (sSOL) of >= 30 minutes after keeping a sleep diary for at least 3 days
(2) Patients who have insomnia symptoms (ISI score >= 11) at 4 weeks after sleep hygiene education by a physician
(3) Patients who have not received pharmacotherapy or cognitive behavioral therapy for insomnia for 4 weeks at screening step 2
Screening step 1
(1) Patients with hypersomnolence disorder, narcolepsy, breathing-related sleep disorders, or parasomnias
(2) Patients with symptoms suspected of hypersomnolence disorder, narcolepsy, breathing-related sleep disorders, or parasomnias according to the investigator's or subinvestigator's clinical opinion
(3) Patients with moderate or higher anxiety symptoms (GAD-7 score >= 10)
(4) Patients with moderate or higher depressive symptoms (PHQ-9 >= 10)
(5) Patients with suicidal ideations (the ninth item of PHQ-9, suicidal ideation score >= 2 )
(6) Patients who habitually go to bed later than 2 am or wake up later than 10 am due to night shift
(7) Patients who are pregnant, breastfeeding (including discontinued breastfeeding), or planning a pregnancy during the study
(8) Patients who have been diagnosed by a medical institution as having alcohol or drug dependence within the past year (not including habitual smokers)
(9) Patients with any condition that may affect the safety of the subject or the conduct of this study (e.g., may affect sleep)
(10) Patients who are engaged in dangerous mechanical operations such as driving a car
(11) Patients who are currently participating in another clinical trial
(12) Patients who have received cognitive behavioral therapy for insomnia in the past
(13)Other patients who are judged by the investigator or sub investigator to be inappropriate to participate in this clinical trial.
Screening step 2
(1) Patients with the following diseases that the investigator or subinvestigator determines may affect the safety of the subject or the conduct of this clinical trial
(2) Other patients who are judged by the investigator or sub investigator to be inappropriate to participate in this clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change at 5 weeks from baseline in sSOL (subjective sleep onset latency)
- Secondary Outcome Measures
Name Time Method