Digital Management of Sleep Health

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.

Study Overview

• Status: Completed
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: dCBT-I; Behavioral: Relaxing music

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.

• Study Type: Interventional
• Enrollment (Actual): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Participants receive digital cognitive behavioral intervention for insomnia(dCBT-I) via their smartphone, and can freely access relaxing music in the app	Behavioral: 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.; Behavioral: Relaxing music; Participants can freely listen relaxing music
Other: Control Group; Participants can only freely access relaxing music in the app. They don't have access to dCBT-I	Behavioral: Relaxing music; Participants can freely listen relaxing music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index Scale(PSQI)	A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome	baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Insomnia Severity Index Scale(ISI)	A scale that evaluates the severity of insomnia, the scale scores range from 0 to 28, and lower scores mean a better outcome	baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Dysfunctional Beliefs and Attitudes about Sleep Scale(DBAS)	A scale that evaluates the sleep attitude, the scale scores range from 0 to 64, and lower scores mean a better outcome	baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Sleep Hygiene Index Scale(SHI)	A scale that evaluates sleep hygiene, the scale scores range from 0 to 52, and lower scores mean a better outcome	baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Epworth Sleepiness Scale(ESS)	A scale that evaluates sleepiness, the scale scores range from 0 to 24, and lower scores mean a better outcome	baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)

Collaborators and Investigators

• Sponsor: Jia Xiu
• Investigators: Study Chair: Shouyan Wang, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Insomnia; Digital cognitive behavior therapy for insomnia
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: FE22197I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to concerns regarding patient confidentiality and privacy, the investigators are unable to share the data from our study. The sensitive nature of the data includes personal health information that could potentially identify individual participants. Despite our best efforts to anonymize the data, the risk of re-identification remains. Additionally, the investigators are bound by ethical guidelines and institutional policies that require us to protect the privacy of our participants and maintain the confidentiality of their information. As such, the investigators must restrict access to the data to ensure compliance with these ethical and legal standards.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No