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Software-delivered CBT-I for Insomnia Disorder

Primary Purpose

Insomnia Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
software-delivered CBT-I
online PE
Sponsored by
Peking University Sixth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Disorder focused on measuring Insomnia Disorder, Software-delivered CBT-I, Randomised Clinical Trial, Digital Therapy

Eligibility Criteria

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

Inclusion Criteria: Aged ≥18 years old, no gender limitation; Own a mobile-phone, access the Internet, and be skilled in using software; Meet the diagnostic criteria of insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5); Insomnia symptoms appear at least 3 nights per week and last for at least 3 months; ISI scores ≥ 12 ; Volunteer to participate in this experiment and sign a written informed consent. Exclusion Criteria: Generalized Anxiety Disorder Scale-7 (GAD-7) scores ≥ 15; Patients Health Questionnaire-9 (PHQ-9) scores ≥ 20; Current thoughts of suicide or self-injury (defined as PHQ-9 9th item score ≥ 1); Confirmed physical diseases that may affect sleep, such as congestive heart failure, chronic obstructive pulmonary disease acute phase, cardiovascular and cerebrovascular disease acute phase, etc. Current diagnosed neurological or mental illness (major depressive disorder, bipolar disorder, epilepsy, schizophrenia, etc.) that may affect sleep; Diagnoses of other untreated sleep disorders, such as obstructive sleep apnea, restless leg syndrome (RLS); Usual bedtime (when the subject attempts to fall asleep) is earlier than 8 p.m. or later than 2 a.m., or usual waking (arising) time is earlier than 4 a.m. or later than 10 a.m. Alcohol or drug abusers (other than nicotine dependence) in the past year; Pregnant or lactating women; Undergoing systematic psychotherapy within the past 3 months; Undergoing other cognitive behavioral therapy for sleep disorders; Unstable usage of medication regimens that affect sleep (changes in type, dosage and method of use within the past 1 month); Night shift workers, travelers across time zones; Subjects who have not responded to previous CBT-I; Other conditions deemed unsuitable for clinical trials by the investigator.

Sites / Locations

  • Peking University Sixth HospitalRecruiting
  • Peking University First HospitalRecruiting
  • Shenzhen Kangning HospitalRecruiting
  • The Second Affiliated Hospital of AFMURecruiting
  • Sichuan Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

software-delivered CBT-I

online PE

Arm Description

Subjects in intervention group will receive a digital CBT-I for 6 weeks. The automated software incorporates all core elements of CBT-I, tailoring content based on each participant's reported baseline sleep function and sleep progress.

Subjects in control group will receive information about insomnia and sleep health education content.

Outcomes

Primary Outcome Measures

The Change of Insomnia Severity from Baseline to Follow-up
The insomnia severity is assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire well validated in insomnia research in multiple patient populations. The change of ISI scores from baseline to follow-up is the primary outcome.

Secondary Outcome Measures

Insomnia Remission
Insomnia remission was evaluated by a masked assessor using a semi-structured interview.
Insomnia Treatment Response
Insomnia treatment response was defined by a decrease in ISI by at least 8 points.
Sleep Parameters Assessed by Sleep Diary
Sleep diaries related parameters include time taken to fall asleep (sleep onset latency), wake after sleep onset, total sleep, total time in bed, and sleep efficiency.
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality.
Depression
Patient Health Questionnaire-9 (PHQ-9) is used to evaluate the severity of depression.
Anxiety
Generalized Anxiety Disorder Scale-7 (GAD-7) is used to evaluate the severity of anxiety.
Life Quality
WHOQOL-BREF is used to evaluate the life quality.

Full Information

First Posted
February 11, 2023
Last Updated
May 8, 2023
Sponsor
Peking University Sixth Hospital
Collaborators
Shenzhen Zeen Health Technology Co., Ltd., Peking University First Hospital, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of AFMU, Shenzhen Kangning Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05747963
Brief Title
Software-delivered CBT-I for Insomnia Disorder
Official Title
A Prospective, Multicenter, Randomized Clinical Trial for Evaluating the Safety and Efficacy of Software-delivered Cognitive Behavioral Therapy for Insomnia in Patients With Insomnia Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Sixth Hospital
Collaborators
Shenzhen Zeen Health Technology Co., Ltd., Peking University First Hospital, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of AFMU, Shenzhen Kangning Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this prospective multicenter clinical trial is to evaluate the efficacy and safety of software-delivered cognitive behavioral therapy for insomnia (CBT-I) in Chinese patients with insomnia disorder (ID). The main questions it aims to answer are: (1) whether the software-delivered CBT-I is more effective than an online patient education (online-PE) at improving insomnia. (2) whether the software-delivered CBT-I is safe for treatment of insomnia symptoms. Participants will be randomized to receive (1) a software-delivered CBT-I using automated software called 'resleep' (one kind of digital device expected to treat insomnia targeted for Chinese patients); (2) online patient education (online-PE) about sleep. Researchers will compare the efficacy of a software-delivered CBT-I program and an online sleep education control at improving insomnia symptoms and other psychological outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder
Keywords
Insomnia Disorder, Software-delivered CBT-I, Randomised Clinical Trial, Digital Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, multicenter, parallel, randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
software-delivered CBT-I
Arm Type
Experimental
Arm Description
Subjects in intervention group will receive a digital CBT-I for 6 weeks. The automated software incorporates all core elements of CBT-I, tailoring content based on each participant's reported baseline sleep function and sleep progress.
Arm Title
online PE
Arm Type
Active Comparator
Arm Description
Subjects in control group will receive information about insomnia and sleep health education content.
Intervention Type
Device
Intervention Name(s)
software-delivered CBT-I
Intervention Description
The automated software called 'resleep' incorporates all core elements of CBT-I: sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene and education, tailoring content based on each participant's reported baseline sleep function and sleep progress. The 6-week treatment includes 42 times of intervention.
Intervention Type
Other
Intervention Name(s)
online PE
Intervention Description
Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account.
Primary Outcome Measure Information:
Title
The Change of Insomnia Severity from Baseline to Follow-up
Description
The insomnia severity is assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire well validated in insomnia research in multiple patient populations. The change of ISI scores from baseline to follow-up is the primary outcome.
Time Frame
Baseline, post-intervention, follow-up (3 months after post-intervention)
Secondary Outcome Measure Information:
Title
Insomnia Remission
Description
Insomnia remission was evaluated by a masked assessor using a semi-structured interview.
Time Frame
Baseline, post-intervention, follow-up (3 months after post-intervention)
Title
Insomnia Treatment Response
Description
Insomnia treatment response was defined by a decrease in ISI by at least 8 points.
Time Frame
Baseline, post-intervention, follow-up (3 months after post-intervention)
Title
Sleep Parameters Assessed by Sleep Diary
Description
Sleep diaries related parameters include time taken to fall asleep (sleep onset latency), wake after sleep onset, total sleep, total time in bed, and sleep efficiency.
Time Frame
Baseline, post-intervention, follow-up (3 months after post-intervention)
Title
Sleep Quality
Description
Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality.
Time Frame
Baseline, post-intervention, follow-up (3 months after post-intervention)
Title
Depression
Description
Patient Health Questionnaire-9 (PHQ-9) is used to evaluate the severity of depression.
Time Frame
Baseline, post-intervention, follow-up (3 months after post-intervention)
Title
Anxiety
Description
Generalized Anxiety Disorder Scale-7 (GAD-7) is used to evaluate the severity of anxiety.
Time Frame
Baseline, post-intervention, follow-up (3 months after post-intervention)
Title
Life Quality
Description
WHOQOL-BREF is used to evaluate the life quality.
Time Frame
Baseline, post-intervention, follow-up (3 months after post-intervention)
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Adverse events will be recorded throughout this trial for evaluating the safety of software.
Time Frame
Baseline, post-intervention, follow-up (3 months after post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥18 years old, no gender limitation; Own a mobile-phone, access the Internet, and be skilled in using software; Meet the diagnostic criteria of insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5); Insomnia symptoms appear at least 3 nights per week and last for at least 3 months; ISI scores ≥ 12 ; Volunteer to participate in this experiment and sign a written informed consent. Exclusion Criteria: Generalized Anxiety Disorder Scale-7 (GAD-7) scores ≥ 15; Patients Health Questionnaire-9 (PHQ-9) scores ≥ 20; Current thoughts of suicide or self-injury (defined as PHQ-9 9th item score ≥ 1); Confirmed physical diseases that may affect sleep, such as congestive heart failure, chronic obstructive pulmonary disease acute phase, cardiovascular and cerebrovascular disease acute phase, etc. Current diagnosed neurological or mental illness (major depressive disorder, bipolar disorder, epilepsy, schizophrenia, etc.) that may affect sleep; Diagnoses of other untreated sleep disorders, such as obstructive sleep apnea, restless leg syndrome (RLS); Usual bedtime (when the subject attempts to fall asleep) is earlier than 8 p.m. or later than 2 a.m., or usual waking (arising) time is earlier than 4 a.m. or later than 10 a.m. Alcohol or drug abusers (other than nicotine dependence) in the past year; Pregnant or lactating women; Undergoing systematic psychotherapy within the past 3 months; Undergoing other cognitive behavioral therapy for sleep disorders; Unstable usage of medication regimens that affect sleep (changes in type, dosage and method of use within the past 1 month); Night shift workers, travelers across time zones; Subjects who have not responded to previous CBT-I; Other conditions deemed unsuitable for clinical trials by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongqiang Sun
Phone
+8613911043951
Email
sunhq@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Chen
Phone
+8619801107132
Email
claudchen@bjmu.edu.cn
Facility Information:
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Chen
Phone
+8619801107132
Email
claudchen@bjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Hongqiang Sun
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Ma
First Name & Middle Initial & Last Name & Degree
Jing Ma
Facility Name
Shenzhen Kangning Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Liang
First Name & Middle Initial & Last Name & Degree
Wei Liang
Facility Name
The Second Affiliated Hospital of AFMU
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changjun Su
First Name & Middle Initial & Last Name & Degree
Changjun Su
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Zhou
First Name & Middle Initial & Last Name & Degree
Bo Zhou

12. IPD Sharing Statement

Plan to Share IPD
No

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Software-delivered CBT-I for Insomnia Disorder

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