An interventional study of software-delivered CBT-I and online PE in Insomnia Disorder, sponsored by Peking University Sixth Hospital. Completed at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Peking University Sixth Hospital · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 236 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Peking University Sixth Hospital is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Subjects in intervention group will receive a digital CBT-I for 6 weeks. The automated software incorporates all core elements of CBT-I, tailoring content based on each participant's reported baseline sleep function and sleep progress.
Device: software-delivered CBT-I
Subjects in control group will receive information about insomnia and sleep health education content.
Other: online PE
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.
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)
Adverse Events
Adverse events will be recorded throughout this trial for evaluating the safety of software.
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Peking University Sixth Hospital