Primary InsomniaNCT05416346
Digital Cognitive Behavioral Therapy for Insomnia in China
A study testing Digital Cognitive Behavioral Therapy and Sleep Hygiene Education (SHE) in people with Primary Insomnia, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Digital Cognitive Behavioral Therapy and Sleep Hygiene Education (SHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2021to 12 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Primary Insomnia
- Being tested
- Digital Cognitive Behavioral Therapy, Sleep Hygiene Education (SHE)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cognitive Behavioral TherapyBehavioural
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)Behavioural
The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.
| Study group | Role | What they receive |
|---|---|---|
| dCBT-i | Experimental | The dCBT-i group received the whole intervention Receives: 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. Receives: Behavioral: Digital Cognitive Behavioral Therapy; Behavioral: Sleep Hygiene Education (SHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep diary
recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality
Measured: 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.
Measured: week 4
Secondary outcomes (5)
the Insomnia Severity Index 7-item version
It scores between 0 to 28, with higher scores meaning more severe insomnia.
Measured: 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.
Measured: week 4
the Epworth Sleepiness Scale
It scores between 0 to 24, with higher scores meaning greater sleepiness.
Measured: week 4
the Patient Health Questionnaire 9-item version
It scores between 0 to 27, with higher scores meaning higher depressive symptoms.
Measured: week 4
the Generalized Anxiety Disorder 7-item version
It scores between 0 to 21, with higher scores meaning higher anxious symptoms.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start12 Apr 2021
- Primary completion12 Jun 2021
- Study completion12 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416346
- Sponsor's protocol ID
- dCBT-i-Chinese
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in China: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05416346
- Acronym / sponsor ID
- dCBT-i-Chinese
- Conditions
- Primary Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 12 Jun 2021 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dCBT-i | Experimental | Behavioral: Digital Cognitive Behavioral TherapyThe dCBT-i group received the whole intervention |
| Sleep Hygiene Education (SHE) | Active comparator | Behavioral: Digital Cognitive Behavioral Therapy, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Cognitive Behavioral TherapyCognitive 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 | Behavioural | Sleep Hygiene Education (SHE), dCBT-i |
| 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. | Behavioural | Sleep Hygiene Education (SHE) |
Primary outcome
sleep diary
Time frame: week 4
recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality
Sleep Condition Indicator-8
Time frame: 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.
5 secondary outcomes
the Insomnia Severity Index 7-item version
Time frame: week 4
the Dysfunctional Beliefs and Attitudes about Sleep Scale 16-item version
Time frame: week 4
the Epworth Sleepiness Scale
Time frame: week 4
the Patient Health Questionnaire 9-item version
Time frame: week 4
the Generalized Anxiety Disorder 7-item version
Time frame: week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Cognitive Behavioral Therapy and Sleep Hygiene Education (SHE) in people with Primary Insomnia, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep diary (time frame: week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.