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

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.

Study Overview

• Status: Completed
• Conditions: Primary Insomnia
• Intervention / Treatment: Behavioral: Digital Cognitive Behavioral Therapy; Behavioral: Sleep Hygiene Education (SHE)

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dCBT-i; The dCBT-i group received the whole 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
Active Comparator: 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.	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; Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): June 12, 2021
• Study Completion (Actual): June 12, 2021

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: dCBT-i-Chinese

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No