Digital Management of Sleep Health
- Conditions
- Chronic Insomnia
- Interventions
- Behavioral: dCBT-IBehavioral: Relaxing music
- Registration Number
- NCT06481423
- Lead Sponsor
- Jia Xiu
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Age 18-65 years old
- Insomnia Severity Index Scale (ISI) score of 8~21
- Proficient in the use of smartphones
- Chinese native speaker
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Relaxing music Participants receive digital cognitive behavioral intervention for insomnia(dCBT-I) via their smartphone, and can freely access relaxing music in the app Control Group Relaxing music Participants can only freely access relaxing music in the app. They don't have access to dCBT-I Intervention Group dCBT-I Participants receive digital cognitive behavioral intervention for insomnia(dCBT-I) via their smartphone, and can freely access relaxing music in the app
- Primary Outcome Measures
Name Time Method The Insomnia Severity Index Scale(ISI) baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up) A scale that evaluates the severity of insomnia, the scale scores range from 0 to 28, and lower scores mean a better outcome
Pittsburgh Sleep Quality Index Scale(PSQI) baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up) A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome
- Secondary Outcome Measures
Name Time Method Epworth Sleepiness Scale(ESS) baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up) A scale that evaluates sleepiness, the scale scores range from 0 to 24, and lower scores mean a better outcome
Dysfunctional Beliefs and Attitudes about Sleep Scale(DBAS) baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up) A scale that evaluates the sleep attitude, the scale scores range from 0 to 64, and lower scores mean a better outcome
Sleep Hygiene Index Scale(SHI) baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up) A scale that evaluates sleep hygiene, the scale scores range from 0 to 52, and lower scores mean a better outcome
Trial Locations
- Locations (1)
Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University
🇨🇳Shanghai, Shanghai, China