Digital Cognitive Behavioral Therapy for Insomnia in China

Primary Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05416346
• Other study ID #: dCBT-i-Chinese
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: June 12, 2021

Study information

• Verified date: June 2022
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: June 12, 2021
• Est. primary completion date: June 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Digital Cognitive Behavioral Therapy
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
• 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.

Locations

Country	Name	City	State
China	Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep diary	recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality	week 4
Primary	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	the Insomnia Severity Index 7-item version	It scores between 0 to 28, with higher scores meaning more severe insomnia.	week 4
Secondary	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
Secondary	the Epworth Sleepiness Scale	It scores between 0 to 24, with higher scores meaning greater sleepiness.	week 4
Secondary	the Patient Health Questionnaire 9-item version	It scores between 0 to 27, with higher scores meaning higher depressive symptoms.	week 4
Secondary	the Generalized Anxiety Disorder 7-item version	It scores between 0 to 21, with higher scores meaning higher anxious symptoms.	week 4