The goal of this prospective multicenter clinical trial is to evaluate the efficacy and safety of software-delivered cognitive behavioral therapy for insomnia (CBT-I) in Chinese patients with insomnia disorder (ID). The main questions it aims to answer are: (1) whether the software-delivered CBT-I is more effective than an online patient education (online-PE) at improving insomnia. (2) whether the software-delivered CBT-I is safe for treatment of insomnia symptoms. Participants will be randomized to receive (1) a software-delivered CBT-I using automated software called 'resleep' (one kind of digital device expected to treat insomnia targeted for Chinese patients); (2) online patient education (online-PE) about sleep. Researchers will compare the efficacy of a software-delivered CBT-I program and an online sleep education control at improving insomnia symptoms and other psychological outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
236
The automated software called 'resleep' incorporates all core elements of CBT-I: sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene and education, tailoring content based on each participant's reported baseline sleep function and sleep progress. The 6-week treatment includes 42 times of intervention.
Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account.
Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Shenzhen Kangning Hospital
Shenzhen, Guangdong, China
The Second Affiliated Hospital of AFMU
Xi'an, Shaanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Change of Insomnia Severity from Baseline to Follow-up
The insomnia severity is assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire well validated in insomnia research in multiple patient populations. The change of ISI scores from baseline to follow-up is the primary outcome.
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Insomnia Remission
Insomnia remission was evaluated by a masked assessor using a semi-structured interview.
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Insomnia Treatment Response
Insomnia treatment response was defined by a decrease in ISI by at least 8 points.
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Sleep Parameters Assessed by Sleep Diary
Sleep diaries related parameters include time taken to fall asleep (sleep onset latency), wake after sleep onset, total sleep, total time in bed, and sleep efficiency.
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality.
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Depression
Patient Health Questionnaire-9 (PHQ-9) is used to evaluate the severity of depression.
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Anxiety
Generalized Anxiety Disorder Scale-7 (GAD-7) is used to evaluate the severity of anxiety.
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Life Quality
WHOQOL-BREF is used to evaluate the life quality.
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
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