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

NCT04779372 | Completed DMC

• 1 other identifier: 2020-773
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Insomnia

Keywords

Insomia, CBTI, Online treatment, Telemedicine, Sleep

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (9)

• Sleep characters recorded by online sleep diary

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

• Sleep characters recorded by smart bracelet

  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)

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

• Fatigue Severity Scale(FSS)

  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)

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

Study Arms (2)

Group of dCBT-I

EXPERIMENTAL

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

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

Behavioral: sleep education

Interventions

smartphone-based dCBT-I from a Wechat applet BEHAVIORAL

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

Group of dCBT-I

sleep education BEHAVIORAL

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

Group of sleep education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Zeen health (Beijing) Technology Co., Ltd: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (1)

• 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.

  PMID: 36972049 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jing Ma, Doctor

  Peking University First Hospital

  STUDY CHAIR

• Cheng Zhang, Doctor

  Peking University First Hospital

  STUDY DIRECTOR

• Yanan Liu, Doctor

  Peking University First Hospital

  STUDY DIRECTOR

• Yane Shen, Postgraduate

  Peking University First Hospital

  STUDY DIRECTOR

• Xiaoming Guo, Doctor

  Peking University First Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

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

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 3, 2021
• Study Start: March 24, 2021
• Primary Completion: January 6, 2022
• Study Completion: July 6, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)