Digital Cognitive Behavioral Therapy for Insomnia in China

Not Applicable

Completed

• Conditions: Primary Insomnia
• Interventions: Behavioral: Digital Cognitive Behavioral Therapy; Behavioral: Sleep Hygiene Education (SHE)

• 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

Study Timeline

• Study Start: 2021-04-12
• Primary Completion: 2021-06-12
• Study Completion: 2021-06-12
• Status Verified: 2022-06
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-16

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

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene Education (SHE)	Digital Cognitive Behavioral Therapy	The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.
Sleep Hygiene Education (SHE)	Sleep Hygiene Education (SHE)	The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.
dCBT-i	Digital Cognitive Behavioral Therapy	The dCBT-i group received the whole intervention

Primary Outcome Measures

Name	Time	Method
Sleep Condition Indicator-8	week 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 diary	week 4	recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University; 🇨🇳 Beijing, Beijing, China