Clinical trial NCT04779372: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: Insomia, CBTI, Online treatment, Telemedicine, Sleep
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Zeen health (Beijing) Technology Co., Ltd
First posted: 2021-03-03
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be random allocation into two groups named Group dCBT-I and Group Sleep Education.
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Age≥18y;
2. 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.
3. Insomnia Severity Index (ISI) ≥14;
4. 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.
5. Can use APP/ Wechat applet skillfully, can freely communicate, read and fill the electronic questionnaire, well understanding.
6. Sign informed consent

Exclusion Criteria:

1. The presence of shift work, head injury, acute suicidality, current mania, schizophrenia or elevated substance use.
2. With documented severe physical diseases impairing sleep: such as craniocerebral disease, cancer pain, unstable angina or uncontrolled heart failure, etc.
3. Current or past CBT-I
4. Epworth Sleepiness Scale (ESS) ≥12
5. Without informed consent or not signed

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: V2 and V4 visit ( 6, 18 weeks after recruitment).
Secondary outcomes:
measure: Sleep characters recorded by online sleep diary
timeFrame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
measure: Sleep characters recorded by smart bracelet
timeFrame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
measure: Dysfunctional Beliefs and Attitudes about sleep scale (DBAS-16)
timeFrame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
measure: Fatigue Severity Scale(FSS)
timeFrame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
measure: Health-related Quality of Life (SF-12)
timeFrame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
measure: Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.
measure: Insomnia Severity Index (ISI) at V3 and V5 visit
timeFrame: V3 and V5 visit ( 10, 30 weeks after recruitment).
measure: Insomnia Severity Index (ISI) improvement
timeFrame: 6, 10,18, 30 weeks after recruitment.
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, and 6, 10,18, 30 weeks after recruitment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Jing Ma, Doctor
role: STUDY_CHAIR
affiliation: Peking University First Hospital
name: Cheng Zhang, Doctor
role: STUDY_DIRECTOR
affiliation: Peking University First Hospital
name: Yanan Liu, Doctor
role: STUDY_DIRECTOR
affiliation: Peking University First Hospital
name: Yane Shen, Postgraduate
role: STUDY_DIRECTOR
affiliation: Peking University First Hospital
name: Xiaoming Guo, Doctor
role: STUDY_DIRECTOR
References: