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Digital Cognitive Behavioral Therapy for Insomnia in China

Not Applicable
Completed
Conditions
Primary Insomnia
Registration Number
NCT05416346
Lead Sponsor
Peking University
Brief Summary

Digital cognitive behavioral therapy for insomnia (dCBT-i) is found to be effective but is rarely used in China. Hence, the investigators developed an automated Chinese dCBT-i program and examined its feasibility, acceptability, and preliminary effectiveness in individuals with insomnia symptoms.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
217
Inclusion Criteria
  • were aged 18 or older;
  • had a positive screening result for chronic insomnia, i.e., a score of 16 or lower on the Sleep Condition Indicator (SCI);
  • had stable access to the internet via a smartphone.
Exclusion Criteria
  • additional sleeping conditions except for insomnia (such as restless legs syndrome and sleep apnea);
  • psychosis or mania;
  • serious physical health concerns necessitating surgery or with prognosis <6 months;
  • undergoing medical or psychological treatment for insomnia with a health professional;
  • habitual night shift, evening, or rotating shift-workers.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Sleep Condition Indicator-8week 4

Sleep Condition Indicator-8 is an 8-item scale validated against Diagnostic and Statistical Manual-5 criteria, concerning sleep quality and daytime personal functioning. It scores between 0 to 32, with higher scores meaning better sleep.

sleep diaryweek 4

recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality

Secondary Outcome Measures
NameTimeMethod
the Insomnia Severity Index 7-item versionweek 4

It scores between 0 to 28, with higher scores meaning more severe insomnia.

the Generalized Anxiety Disorder 7-item versionweek 4

It scores between 0 to 21, with higher scores meaning higher anxious symptoms.

the Patient Health Questionnaire 9-item versionweek 4

It scores between 0 to 27, with higher scores meaning higher depressive symptoms.

the Dysfunctional Beliefs and Attitudes about Sleep Scale 16-item versionweek 4

It scores between 16 to 80, with higher scores meaning more dysfunctional beliefs.

the Epworth Sleepiness Scaleweek 4

It scores between 0 to 24, with higher scores meaning greater sleepiness.

Trial Locations

Locations (1)

Peking University

🇨🇳

Beijing, Beijing, China

Peking University
🇨🇳Beijing, Beijing, China

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