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Digital Cognitive Behavioral Therapy for Insomnia in China

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05416346
Enrollment
217
Registered
2022-06-13
Start date
2021-04-12
Completion date
2021-06-12
Last updated
2022-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

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.

Interventions

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

The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.

Sponsors

Peking University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
sleep diaryweek 4recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality
Sleep Condition Indicator-8week 4Sleep 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.

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026