Digital Cognitive Behavioral Therapy for Insomnia in China

Study Overview
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Brief Summary
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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.

Official Title
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The Feasibility and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in China: A Pilot Randomized Controlled Trial

Conditions
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Primary Insomnia

Intervention / Treatment
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* Behavioral: Digital Cognitive Behavioral Therapy
* Behavioral: Sleep Hygiene Education (SHE)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dCBT-i<br>The dCBT-i group received the whole intervention | Behavioral: Digital Cognitive Behavioral Therapy<br>* Cognitive behavioral therapy for insomnia (CBT-i) has been showed to be effective in reducing insomnia symptoms and insomnia-related symptoms, including sleepiness, dysfunctional beliefs and attitudes about sleep, anxiety and depressive symptoms<br>|
| Active Comparator: Sleep Hygiene Education (SHE)<br>The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks. | Behavioral: Digital Cognitive Behavioral Therapy<br>* Cognitive behavioral therapy for insomnia (CBT-i) has been showed to be effective in reducing insomnia symptoms and insomnia-related symptoms, including sleepiness, dysfunctional beliefs and attitudes about sleep, anxiety and depressive symptoms<br>Behavioral: Sleep Hygiene Education (SHE)<br>* The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep diary | recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality | week 4 | 
| Sleep Condition Indicator-8 | 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. | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Insomnia Severity Index 7-item version | It scores between 0 to 28, with higher scores meaning more severe insomnia. | week 4 | 
| the Dysfunctional Beliefs and Attitudes about Sleep Scale 16-item version | It scores between 16 to 80, with higher scores meaning more dysfunctional beliefs. | week 4 | 
| the Epworth Sleepiness Scale | It scores between 0 to 24, with higher scores meaning greater sleepiness. | week 4 | 
| the Patient Health Questionnaire 9-item version | It scores between 0 to 27, with higher scores meaning higher depressive symptoms. | week 4 | 
| the Generalized Anxiety Disorder 7-item version | It scores between 0 to 21, with higher scores meaning higher anxious symptoms. | week 4 |