Trials / Completed
CompletedNCT05747963
Software-delivered CBT-I for Insomnia Disorder
A Prospective, Multicenter, Randomized Clinical Trial for Evaluating the Safety and Efficacy of Software-delivered Cognitive Behavioral Therapy for Insomnia in Patients With Insomnia Disorder.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 236 (actual)
- Sponsor
- Peking University Sixth Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | software-delivered CBT-I | 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. |
| OTHER | online PE | Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account. |
Timeline
- Start date
- 2023-03-21
- Primary completion
- 2024-03-21
- Completion
- 2024-03-21
- First posted
- 2023-02-28
- Last updated
- 2024-08-06
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05747963. Inclusion in this directory is not an endorsement.