Chronic InsomniaNCT04779372
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia ：A Randomized Controlled Trial
A study testing smartphone-based dCBT-I from a Wechat applet and sleep education in people with Chronic Insomnia, run by Peking University First Hospital at 1 site in China.
Trial summary
This randomized, open, parallel controlled study aims to explore the clinical effectiveness of smartphone-based digital Cognitive behavioural therapy for insomnia（dCBT-I）. Patients who diagnosed chronic insomnia disorder and proficient in using mobile phone intended to receive CBT-I. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- smartphone-based dCBT-I from a Wechat applet and sleep education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2021to 6 Jul 2022
- 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
- Age≥18y;
- Participants who meet proposed ICSD-3 and DSM-5 criterias for persistent Insomnia Disorder. (a) a current complaint of poor sleep (diffculty initiating and/or maintaining sleep, early morning wakening, or non-restorative sleep); with (b) signifcant daytime effects in 1 of 6 domains (fatigue, daytime sleepiness, cognitive impairment [e.g., concentration problems], mood disturbance, impaired occupational or academic functioning [e.g., poor productivity], impaired interpersonal/ social functioning); and (c) affecting them 3 nights per week for 3 months.
- Insomnia Severity Index (ISI) ≥14;
- If a comorbid sleep or psychiatric disorder is present, treatment of this condition should be stable at the time of entry in the study. There is no requirement of insomnia medications.
- Can use APP/ Wechat applet skillfully, can freely communicate, read and fill the electronic questionnaire, well understanding.
- Sign informed consent
Who cannot join
- The presence of shift work, head injury, acute suicidality, current mania, schizophrenia or elevated substance use.
- With documented severe physical diseases impairing sleep: such as craniocerebral disease, cancer pain, unstable angina or uncontrolled heart failure, etc.
- Current or past CBT-I
- Epworth Sleepiness Scale (ESS) ≥12
- Without informed consent or not signed
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
This randomized, open, parallel controlled study aims to explore the clinical effectiveness of smartphone-based digital Cognitive behavioural therapy for insomnia（dCBT-I）. Patients who diagnosed chronic insomnia disorder and proficient in using mobile phone intended to receive CBT-I. Participants will be random allocation into Group dCBT-I and Group Sleep Education. Primary outcome is the insomnia severity as measured using the Insomnia Severity Index (ISI).
Read the detailed description
This is a single-center, randomized, open, parallel controlled study. Patients who had no CBTI treatment before for chronic insomnia will be recruited and followed for 6 weeks. Participants will be random allocation into Group dCBT-I and Group Sleep Education, and then explore the clinical effectiveness of smartphone-based digital CBT-I therapy. We will collect the baseline information: population characteristics, including age, sex, education, employment, living and residential status, demographic data, smoking and alcohol consumption, body mass index (BMI); medical history and medication status and adverse reactions during treatment. Primary outcome is the Insomnia Severity Index (ISI). Secondary outcomes include an online sleep diary measured information regarding: time in bed(TIB), total sleep time (TST), sleep efficiency (SE), total wake time(TWT); bracelet measured information regarding: total sleep time (TST), sleep latency(SL), sleep efficiency (SE), the times of wake from sleep(TWS), sleep quality score setting by bracelet; the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16); Fatigue Severity Scale(FSS); Health-related Quality of Life (SF-12); Generalized Anxiety Disorder Scale-7 (GAD-7); Patient Health Questionnaire-9 (PHQ-9).
- Conditions
- Chronic Insomnia
- Being tested
- smartphone-based dCBT-I from a Wechat applet, sleep education
- Keywords
- Insomia, CBTI, Online treatment, Telemedicine, Sleep
- 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.
smartphone-based dCBT-I from a Wechat appletBehavioural
Participants will receive 6-week smartphone-based dCBT-I from a Wechat applet.
sleep educationBehavioural
Participants will receive sleep education like the advices getting from common sleep clinic.
| Study group | Role | What they receive |
|---|---|---|
| Group of dCBT-I | Experimental | participants will receive 6-week smartphone-based dCBT-I from a Wechat applet Receives: Behavioral: smartphone-based dCBT-I from a Wechat applet |
| Group of sleep education | Sham comparator | Patients will receive sleep health education like the advices getting from common sleep clinic by the same applet as the group of CBT-I in smartphone Receives: Behavioral: sleep education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The ISI is a 6-item self-report measure of impairment in daytime functioning due to inadequate sleep. The ISI shows adequate internal consistency, appropriate test-retest reliability, and sensitivity to change with treatment. Scores can range from 0 to 28, with higher scores indicating more impairment. Scores higher than 14 are thought to be indicative of the presence of clinical insomnia and change in scores of 8.4 have been found to reflect moderate improvement in clinical samples.
Measured: V2 and V4 visit ( 6, 18 weeks after recruitment).
Secondary outcomes (9)
Sleep characters recorded by online sleep diary
Participants will be encouraged to record sleep diaries each day duration the 6-week of intervention. Participants will complete 7-day online sleep diaries at baseline before recruitment, and 1month, 3month and 6month after intervention. The following parameters extracted from the diary will be used for analysis: time in bed(TIB), total sleep time (TST), sleep latency(SL), sleep efficiency (SE), the times of wake from sleep(TWS), self-scored sleep quality. Data suggest that tracking sleep parameters through these diaries can provide a more comprehensive understanding of sleep status.
Measured: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Sleep characters recorded by smart bracelet
The participants will wear the bracelet everyday at each evaluating time point for at least week before each evaluation/visit. The following parameters recorded by the bracelet will be used for analysis: total sleep time (TST), sleep latency(SL), sleep efficiency (SE), the times of wake from sleep(TWS), sleep quality score setting by bracelet.
Measured: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Dysfunctional Beliefs and Attitudes about sleep scale (DBAS-16)
All items in DBAS-16 will be answered on a 10-point Likert scale ranging from 0 (strongly disagree) to 10 (strongly agree). As emphasized by Morin et al, there is no absolute right or wrong answer for a single item. Rather, the degree to which a particular item is endorsed by a participant is a reflection of the nature of the dysfunction. The mean scores are summed to generate a DBAS-16 overall index and four subscales (consequences, worry/helplessness, expectations, medication), with higher scores reflecting stronger dysfunctional beliefs and attitudes about sleep.
Measured: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Fatigue Severity Scale(FSS)
The scale employs nine items to measure the self-reported impact of fatigue. Responses to individual items are rated on a 7-point Likert scale, ranging from 1 = strongly disagree to 7 = strongly agree. The FSS score is calculated as the mean of all item scores, with a score of C4 indicating abnormal fatigue and a score of C5 indicating severe fatigue.
Measured: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Health-related Quality of Life (SF-12)
The SF-12 derived from the SF-36 and measured Quality of Life with 12 items. It generates a profile of respondents HRQoL across eight domains: physical function (PH), role physical (RP), bodily pain (BP), general health (GH), vitality (V), social function (SF), role emotion (RE), and mental health (MH). Finally, the SF-12 generates a summary of physical functional scores (PCS) and mental functional scores (MCS). The PCS is calculated based on a combination of physical functioning, role physical, bodily pain and general health scores. The MCS is calculated based on a combination of vitality, social functioning, role emotional, and mental health scores.
Measured: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Generalized Anxiety Disorder Scale-7 (GAD-7)
The GAD-7 is designed for use in primary care patients. The GAD-7 consists of a self-report questionnaire that allows for the rapid detection of GAD. Subjects will be asked if they are bothered by anxiety related problems over the past two weeks by answering seven items on a 4-point scale. The total scores range from 0 to 21. At a cutoff score of 9, the GAD-7 has a sensitivity of 89 % and a specificity of 82 % for detecting GAD compared with a structured psychiatric interview.
Measured: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Insomnia Severity Index (ISI) at V3 and V5 visit
The comparisons of ISI between CBT-I and control group at V3 and V5 visit
Measured: V3 and V5 visit ( 10, 30 weeks after recruitment).
Insomnia Severity Index (ISI) improvement
Comparisons of ISI improvement values, improvement rate, treatment response rate and insomnia remission rate between dCBT-I group and control group
Measured: 6, 10,18, 30 weeks after recruitment.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a self-report measure of depression used widely in research and as a screening measure in primary care and hospital settings.
Measured: baseline, and 6, 10,18, 30 weeks after recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start24 Mar 2021
- Primary completion6 Jan 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be random allocation into two groups named Group dCBT-I and Group Sleep Education.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zeen health (Beijing) Technology Co., Ltd
- Responsible party
- Principal investigator, Jing MA, Peking University First Hospital
- Investigators
- Jing Ma, Doctor, Study chair, Peking University First HospitalCheng Zhang, Doctor, Study director, Peking University First HospitalYanan Liu, Doctor, Study director, Peking University First HospitalYane Shen, Postgraduate, Study director, Peking University First HospitalXiaoming Guo, Doctor, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779372
- Sponsor's protocol ID
- 2020-773
- Status last verified
- Dec 2022
- First submitted
- 28 Feb 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang C, Liu Y, Guo X, Liu Y, Shen Y, Ma J. Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e234866. doi: 10.1001/jamanetworkopen.2023.4866.
PubMed 36972049
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia ：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04779372
- Acronym / sponsor ID
- 2020-773
- Conditions
- Chronic Insomnia
- Keywords
- Insomia, CBTI, Online treatment, Telemedicine, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Zeen health (Beijing) Technology Co., Ltd
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 3 Mar 2021 (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.
This randomized, open, parallel controlled study aims to explore the clinical effectiveness of smartphone-based digital Cognitive behavioural therapy for insomnia（dCBT-I）. Patients who diagnosed chronic insomnia disorder and proficient in using mobile phone intended to receive CBT-I. Participants will be random allocation into Group dCBT-I and Group Sleep Education. Primary outcome is the insomnia severity as measured using the Insomnia Severity Index (ISI).
Detailed description
This is a single-center, randomized, open, parallel controlled study. Patients who had no CBTI treatment before for chronic insomnia will be recruited and followed for 6 weeks. Participants will be random allocation into Group dCBT-I and Group Sleep Education, and then explore the clinical effectiveness of smartphone-based digital CBT-I therapy. We will collect the baseline information: population characteristics, including age, sex, education, employment, living and residential status, demographic data, smoking and alcohol consumption, body mass index (BMI); medical history and medication status and adverse reactions during treatment. Primary outcome is the Insomnia Severity Index (ISI). Secondary outcomes include an online sleep diary measured information regarding: time in bed(TIB), total sleep time (TST), sleep efficiency (SE), total wake time(TWT); bracelet measured information regarding: total sleep time (TST), sleep latency(SL), sleep efficiency (SE), the times of wake from sleep(TWS), sleep quality score setting by bracelet; the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16); Fatigue Severity Scale(FSS); Health-related Quality of Life (SF-12); Generalized Anxiety Disorder Scale-7 (GAD-7); Patient Health Questionnaire-9 (PHQ-9).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be random allocation into two groups named Group dCBT-I and Group Sleep Education.
| Arm | Type | Receives |
|---|---|---|
| Group of dCBT-I | Experimental | Behavioral: smartphone-based dCBT-I from a Wechat appletparticipants will receive 6-week smartphone-based dCBT-I from a Wechat applet |
| Group of sleep education | Sham comparator | Behavioral: sleep educationPatients will receive sleep health education like the advices getting from common sleep clinic by the same applet as the group of CBT-I in smartphone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥18y;
- Participants who meet proposed ICSD-3 and DSM-5 criterias for persistent Insomnia Disorder. (a) a current complaint of poor sleep (diffculty initiating and/or maintaining sleep, early morning wakening, or non-restorative sleep); with (b) signifcant daytime effects in 1 of 6 domains (fatigue, daytime sleepiness, cognitive impairment [e.g., concentration problems], mood disturbance, impaired occupational or academic functioning [e.g., poor productivity], impaired interpersonal/ social functioning); and (c) affecting them 3 nights per week for 3 months.
- Insomnia Severity Index (ISI) ≥14;
- If a comorbid sleep or psychiatric disorder is present, treatment of this condition should be stable at the time of entry in the study. There is no requirement of insomnia medications.
- Can use APP/ Wechat applet skillfully, can freely communicate, read and fill the electronic questionnaire, well understanding.
Key exclusion criteria (5 listed)
- The presence of shift work, head injury, acute suicidality, current mania, schizophrenia or elevated substance use.
- With documented severe physical diseases impairing sleep: such as craniocerebral disease, cancer pain, unstable angina or uncontrolled heart failure, etc.
- Current or past CBT-I
- Epworth Sleepiness Scale (ESS) ≥12
- Without informed consent or not signed
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 |
|---|---|---|
| smartphone-based dCBT-I from a Wechat appletParticipants will receive 6-week smartphone-based dCBT-I from a Wechat applet. | Behavioural | Group of dCBT-I |
| sleep educationParticipants will receive sleep education like the advices getting from common sleep clinic. | Behavioural | Group of sleep education |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: V2 and V4 visit ( 6, 18 weeks after recruitment).
The ISI is a 6-item self-report measure of impairment in daytime functioning due to inadequate sleep. The ISI shows adequate internal consistency, appropriate test-retest reliability, and sensitivity to change with treatment. Scores can range from 0 to 28, with higher scores indicating more impairment. Scores higher than 14 are thought to be indicative of the presence of clinical insomnia and change in scores of 8.4 have been found to reflect moderate improvement in clinical samples.
9 secondary outcomes
Sleep characters recorded by online sleep diary
Time frame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Sleep characters recorded by smart bracelet
Time frame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Dysfunctional Beliefs and Attitudes about sleep scale (DBAS-16)
Time frame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Fatigue Severity Scale(FSS)
Time frame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Health-related Quality of Life (SF-12)
Time frame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Generalized Anxiety Disorder Scale-7 (GAD-7)
Time frame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
Insomnia Severity Index (ISI) at V3 and V5 visit
Time frame: V3 and V5 visit ( 10, 30 weeks after recruitment).
Insomnia Severity Index (ISI) improvement
Time frame: 6, 10,18, 30 weeks after recruitment.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline, and 6, 10,18, 30 weeks after recruitment.
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 7 Dec 2022.
- Derived from this study: PubMed 36972049Zhang C, Liu Y, Guo X, Liu Y, Shen Y, Ma J. Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e234866. doi: 10.1001/jamanetworkopen.2023.4866.
- Individual participant dataSharing planned: No
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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.
Jing Ma, Doctor study chair
Peking University First Hospital
Cheng Zhang, Doctor study director
Peking University First Hospital
Yanan Liu, Doctor study director
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smartphone-based dCBT-I from a Wechat applet and sleep education in people with Chronic Insomnia, run by Peking University First Hospital 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 6 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 7 Dec 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. Some participants in this study may receive a placebo. 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?
Insomnia Severity Index (ISI) (time frame: V2 and V4 visit ( 6, 18 weeks after recruitment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779372, which also lists 1 linked publication.
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 7 Dec 2022.