Digital Cognitive Behavioral Therapy for Insomnia in China

NCT05416346 | Completed

• 1 other identifier: dCBT-i-Chinese
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Insomnia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• the Insomnia Severity Index 7-item version

  week 4

• the Dysfunctional Beliefs and Attitudes about Sleep Scale 16-item version

  week 4

• the Epworth Sleepiness Scale

  week 4

• the Patient Health Questionnaire 9-item version

  week 4

• the Generalized Anxiety Disorder 7-item version

  week 4

Study Arms (2)

dCBT-i

EXPERIMENTAL

The dCBT-i group received the whole intervention

Behavioral: Digital Cognitive Behavioral Therapy

Sleep Hygiene Education (SHE)

ACTIVE COMPARATOR

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; Behavioral: Sleep Hygiene Education (SHE)

Interventions

Digital Cognitive Behavioral Therapy BEHAVIORAL

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); dCBT-i

Sleep Hygiene Education (SHE) BEHAVIORAL

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: April 12, 2021
• Primary Completion: June 12, 2021
• Study Completion: June 12, 2021
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

CN (1)