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Digital Cognitive Behavioral Therapy for Insomnia in China

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Digital Cognitive Behavioral Therapy
Sleep Hygiene Education (SHE)
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dCBT-i

Sleep Hygiene Education (SHE)

Arm Description

The dCBT-i group received the whole intervention

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

Outcomes

Primary Outcome Measures

sleep diary
recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality
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.

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2022
Last Updated
June 13, 2022
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT05416346
Brief Title
Digital Cognitive Behavioral Therapy for Insomnia in China
Official Title
The Feasibility and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in China: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
June 12, 2021 (Actual)
Study Completion Date
June 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dCBT-i
Arm Type
Experimental
Arm Description
The dCBT-i group received the whole intervention
Arm Title
Sleep Hygiene Education (SHE)
Arm Type
Active Comparator
Arm Description
The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Digital Cognitive Behavioral Therapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Education (SHE)
Intervention Description
The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.
Primary Outcome Measure Information:
Title
sleep diary
Description
recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality
Time Frame
week 4
Title
Sleep Condition Indicator-8
Description
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.
Time Frame
week 4
Secondary Outcome Measure Information:
Title
the Insomnia Severity Index 7-item version
Description
It scores between 0 to 28, with higher scores meaning more severe insomnia.
Time Frame
week 4
Title
the Dysfunctional Beliefs and Attitudes about Sleep Scale 16-item version
Description
It scores between 16 to 80, with higher scores meaning more dysfunctional beliefs.
Time Frame
week 4
Title
the Epworth Sleepiness Scale
Description
It scores between 0 to 24, with higher scores meaning greater sleepiness.
Time Frame
week 4
Title
the Patient Health Questionnaire 9-item version
Description
It scores between 0 to 27, with higher scores meaning higher depressive symptoms.
Time Frame
week 4
Title
the Generalized Anxiety Disorder 7-item version
Description
It scores between 0 to 21, with higher scores meaning higher anxious symptoms.
Time Frame
week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking University
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Digital Cognitive Behavioral Therapy for Insomnia in China

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