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

NCT ID: NCT04779372

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2022-07-06

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).

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group of dCBT-I

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

Group Type: EXPERIMENTAL

smartphone-based dCBT-I from a Wechat applet

Intervention Type: BEHAVIORAL

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

Group of sleep education

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

Group Type: SHAM_COMPARATOR

sleep education

Intervention Type: BEHAVIORAL

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

Interventions

smartphone-based dCBT-I from a Wechat applet

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

Intervention Type: BEHAVIORAL

sleep education

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeen health (Beijing) Technology Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing MA

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Ma, Doctor

Role: STUDY_CHAIR

Peking University First Hospital

Cheng Zhang, Doctor

Role: STUDY_DIRECTOR

Peking University First Hospital

Yanan Liu, Doctor

Role: STUDY_DIRECTOR

Peking University First Hospital

Yane Shen, Postgraduate

Role: STUDY_DIRECTOR

Peking University First Hospital

Xiaoming Guo, Doctor

Role: STUDY_DIRECTOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36972049 (View on PubMed)

Other Identifiers

2020-773

Identifier Type: -

Identifier Source: org_study_id