Digital Management of Sleep Health

NCT ID: NCT06481423

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-09-01

Brief Summary

The goal of this clinical trial is to explore whether cognitive behavioral intervention for insomnia(CBT-I) realized through audio, video, and articles on smartphone apps("ForSleep" developed by the investigators) can improve the sleep quality of insomnia patients. The main question it aims to answer is:

Does CBT-I delivered via smartphone apps improve sleep quality evaluated by scales in patients with insomnia?

Investigators will compare the treatment group receiving the CBT-I intervention via smartphone apps to a control group receiving relaxation training to see if there are significant improvements in sleep quality.

Participants will be asked to:

Use an app("ForSleep") designed for CBT-I to follow a structured therapy program.

Complete daily sleep diaries and periodic scales to track their sleep quality.

Detailed Description

All participants sign the informed consent form online. The study is an online, single-blind, parallel-group, superiority randomized experiment of digital CBT-I(dCBT-I). The randomization is performed using stratified random sampling to ensure non-significant differences in age, gender, and basic sleep quality between the two groups. The screening, informed consent, assessments, allocation to conditions, delivery of the interventions, scale evaluations, and follow-ups are all carried out online. WeChat chatting groups for daily notification and communication are set up respectively. The experiment lasts 5 (and more) weeks included 3 weeks of intervention and 2 weeks of follow-up.

All participants are required to keep sleep diaries. They self-evaluate via Insomnia Severity Index (ISI), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep Hygiene Index (SHI), and Epworth Sleepiness Scale (ESS) to assess insomnia severity, sleep-related cognition, and behaviors at 5 time points. The first 3 times are at the first day, after 7 days and 14 days, before starting each new session. After 3-week program, the above scales are retaken during days 22~25 and days 36~39 as follow-ups. The evaluating time is different on account of individual rate of progress to accomplish the 3-week program.

Digital cognitive behavioral therapy is delivered using an app developed by Fudan University. Digital intervention is structured into 3 sessions with a 7-days course in each session. The intervention group undertook 3 weeks of tasks which consisted of cognitive, behavioral, and relaxation parts of CBT-I and typically lasted 15 minutes per day. Two pieces of relaxing music are recommended daily to the control group instead of the standard relaxation practice. All participants have access to 30 relaxing music and articles on sleep hygiene that are made available in the app.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Participants receive digital cognitive behavioral intervention for insomnia(dCBT-I) via their smartphone, and can freely access relaxing music in the app

Group Type: EXPERIMENTAL

dCBT-I

Intervention Type: BEHAVIORAL

A digital cognitive behavioral intervention course that addresses multiple aspects such as basic sleep knowledge, sleep hygiene, sleep behaviors, improving negative cognition, and improving emotions. The intervention is delivered through video, audio, and text formats.

Relaxing music

Intervention Type: BEHAVIORAL

Participants can freely listen relaxing music

Control Group

Participants can only freely access relaxing music in the app. They don't have access to dCBT-I

Group Type: OTHER

Relaxing music

Intervention Type: BEHAVIORAL

Participants can freely listen relaxing music

Interventions

dCBT-I

A digital cognitive behavioral intervention course that addresses multiple aspects such as basic sleep knowledge, sleep hygiene, sleep behaviors, improving negative cognition, and improving emotions. The intervention is delivered through video, audio, and text formats.

Intervention Type: BEHAVIORAL

Relaxing music

Participants can freely listen relaxing music

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years old
• Insomnia Severity Index Scale (ISI) score of 8~21
• Proficient in the use of smartphones
• Chinese native speaker

Exclusion Criteria

• Those with other combined sleep problems, such as apnoea syndrome, restless leg syndrome, etc.
• Women during pregnancy
• risky jobs that require high concentration, such as working at heights, long-distance driving, etc.
• previous or current diagnosis of severe neurological disorders such as epilepsy
• previous or current diagnosis of mental illness such as depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder, etc.
• history of drug or alcohol abuse
• a significant negative risk of suicide
• serious physical illness (e.g., cardiovascular, hepatic, renal, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jia Xiu

OTHER

Sponsor Role: lead

Responsible Party

Jia Xiu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shouyan Wang, PhD

Role: STUDY_CHAIR

Fudan University

Locations

Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FE22197I

Identifier Type: -

Identifier Source: org_study_id