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Software-delivered CBT-I for Insomnia Disorder

NCT05747963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2024-08-06

No results posted yet for this study

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

  • Insomnia Disorder

Interventions

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.

Sponsors & Collaborators

  • Shenzhen Zeen Health Technology Co., Ltd.

    collaborator UNKNOWN

  • Peking University First Hospital

    collaborator OTHER

  • Sichuan Provincial People's Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of AFMU

    collaborator UNKNOWN

  • Shenzhen Kangning Hospital

    collaborator OTHER

  • Peking University Sixth Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2024-03-21
Completion
2024-03-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05747963 on ClinicalTrials.gov