Status:
COMPLETED
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia ：A Randomized Controlled Trial
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
Zeen health (Beijing) Technology Co., Ltd
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized, open, parallel controlled study aims to explore the clinical effectiveness of smartphone-based digital Cognitive behavioural therapy for insomnia（dCBT-I）. Patients who diagnosed chron...
Detailed Description
This is a single-center, randomized, open, parallel controlled study. Patients who had no CBTI treatment before for chronic insomnia will be recruited and followed for 6 weeks. Participants will be ra...
Eligibility Criteria
Inclusion
- Age≥18y;
- Participants who meet proposed ICSD-3 and DSM-5 criterias for persistent Insomnia Disorder. (a) a current complaint of poor sleep (diffculty initiating and/or maintaining sleep, early morning wakening, or non-restorative sleep); with (b) signifcant daytime effects in 1 of 6 domains (fatigue, daytime sleepiness, cognitive impairment \[e.g., concentration problems\], mood disturbance, impaired occupational or academic functioning \[e.g., poor productivity\], impaired interpersonal/ social functioning); and (c) affecting them 3 nights per week for 3 months.
- Insomnia Severity Index (ISI) ≥14;
- If a comorbid sleep or psychiatric disorder is present, treatment of this condition should be stable at the time of entry in the study. There is no requirement of insomnia medications.
- Can use APP/ Wechat applet skillfully, can freely communicate, read and fill the electronic questionnaire, well understanding.
- Sign informed consent
Exclusion
- The presence of shift work, head injury, acute suicidality, current mania, schizophrenia or elevated substance use.
- With documented severe physical diseases impairing sleep: such as craniocerebral disease, cancer pain, unstable angina or uncontrolled heart failure, etc.
- Current or past CBT-I
- Epworth Sleepiness Scale (ESS) ≥12
- Without informed consent or not signed
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04779372
Start Date
March 24 2021
End Date
July 6 2022
Last Update
December 7 2022
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034