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Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia ：A Randomized Controlled Trial

Primary Purpose

Chronic Insomnia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

smartphone-based dCBT-I from a Wechat applet

sleep education

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomia, CBTI, Online treatment, Telemedicine, Sleep

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group of dCBT-I

Group of sleep education

Arm Description

participants will receive 6-week smartphone-based dCBT-I from a Wechat applet

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Insomnia Severity Index (ISI) at V3 and V5 visit

The comparisons of ISI between CBT-I and control group at V3 and V5 visit

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

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.

Full Information

NCT ID

NCT04779372

First Posted

February 28, 2021

Last Updated

December 4, 2022

Sponsor

Peking University First Hospital

Collaborators

Zeen health (Beijing) Technology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04779372

Brief Title

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia ：A Randomized Controlled Trial

Official Title

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia ：A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

March 24, 2021 (Actual)

Primary Completion Date

January 6, 2022 (Actual)

Study Completion Date

July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University First Hospital

Collaborators

Zeen health (Beijing) Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

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

Chronic Insomnia

Keywords

Insomia, CBTI, Online treatment, Telemedicine, Sleep

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants will be random allocation into two groups named Group dCBT-I and Group Sleep Education.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group of dCBT-I

Arm Type

Experimental

Arm Description

participants will receive 6-week smartphone-based dCBT-I from a Wechat applet

Arm Title

Group of sleep education

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

smartphone-based dCBT-I from a Wechat applet

Intervention Description

Participants will receive 6-week smartphone-based dCBT-I from a Wechat applet.

Intervention Type

Behavioral

Intervention Name(s)

sleep education

Intervention Description

Participants will receive sleep education like the advices getting from common sleep clinic.

Primary Outcome Measure Information:

Title

Insomnia Severity Index (ISI)

Description

Time Frame

V2 and V4 visit ( 6, 18 weeks after recruitment).

Secondary Outcome Measure Information:

Title

Sleep characters recorded by online sleep diary

Description

Time Frame

baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.

Title

Sleep characters recorded by smart bracelet

Description

Time Frame

baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.

Title

Dysfunctional Beliefs and Attitudes about sleep scale (DBAS-16)

Description

Time Frame

baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.

Title

Fatigue Severity Scale(FSS)

Description

Time Frame

baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.

Title

Health-related Quality of Life (SF-12)

Description

Time Frame

baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.

Title

Generalized Anxiety Disorder Scale-7 (GAD-7)

Description

Time Frame

baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.

Title

Insomnia Severity Index (ISI) at V3 and V5 visit

Description

The comparisons of ISI between CBT-I and control group at V3 and V5 visit

Time Frame

V3 and V5 visit ( 10, 30 weeks after recruitment).

Title

Insomnia Severity Index (ISI) improvement

Description

Comparisons of ISI improvement values, improvement rate, treatment response rate and insomnia remission rate between dCBT-I group and control group

Time Frame

6, 10,18, 30 weeks after recruitment.

Title

Patient Health Questionnaire-9 (PHQ-9)

Description

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.

Time Frame

baseline, and 6, 10,18, 30 weeks after recruitment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Ma, Doctor

Organizational Affiliation

Peking University First Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Cheng Zhang, Doctor

Organizational Affiliation

Peking University First Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yanan Liu, Doctor

Organizational Affiliation

Peking University First Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yane Shen, Postgraduate

Organizational Affiliation

Peking University First Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xiaoming Guo, Doctor

Organizational Affiliation

Peking University First Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Peking University First Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia ：A Randomized Controlled Trial

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