Software-delivered CBT-I for Insomnia Disorder

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia Disorder
• Intervention / Treatment: Device: software-delivered CBT-I; Other: online PE

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongqiang Sun; Phone Number: +8613911043951; Email: sunhq@bjmu.edu.cn
• Study Contact Backup: Name: Yun Chen; Phone Number: +8619801107132; Email: claudchen@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University first hospital
      • Principal Investigator: Jing Ma
      • Contact: Jing Ma
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Sixth Hospital
      • Contact: Yun Chen; Phone Number: +8619801107132; Email: claudchen@bjmu.edu.cn
      • Principal Investigator: Hongqiang Sun
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Kangning Hospital
      • Contact: Wei Liang
      • Principal Investigator: Wei Liang
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • The Second Affiliated Hospital of AFMU
      • Contact: Changjun Su
      • Principal Investigator: Changjun Su
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Bo Zhou
      • Principal Investigator: Bo Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: software-delivered CBT-I; 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.	Device: software-delivered CBT-I; 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.
Active Comparator: online PE; Subjects in control group will receive information about insomnia and sleep health education content.	Other: online PE; Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, post-intervention, follow-up (3 months after post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Remission	Insomnia remission was evaluated by a masked assessor using a semi-structured interview.	Baseline, post-intervention, follow-up (3 months after post-intervention)
Insomnia Treatment Response	Insomnia treatment response was defined by a decrease in ISI by at least 8 points.	Baseline, post-intervention, follow-up (3 months after post-intervention)
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.	Baseline, post-intervention, follow-up (3 months after post-intervention)
Sleep Quality	Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality.	Baseline, post-intervention, follow-up (3 months after post-intervention)
Depression	Patient Health Questionnaire-9 (PHQ-9) is used to evaluate the severity of depression.	Baseline, post-intervention, follow-up (3 months after post-intervention)
Anxiety	Generalized Anxiety Disorder Scale-7 (GAD-7) is used to evaluate the severity of anxiety.	Baseline, post-intervention, follow-up (3 months after post-intervention)
Life Quality	WHOQOL-BREF is used to evaluate the life quality.	Baseline, post-intervention, follow-up (3 months after post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse events will be recorded throughout this trial for evaluating the safety of software.	Baseline, post-intervention, follow-up (3 months after post-intervention)

Collaborators and Investigators

• Sponsor: Peking University Sixth Hospital
• Collaborators: Peking University First Hospital; Sichuan Provincial People's Hospital; Shenzhen Kangning Hospital; The Second Affiliated Hospital of AFMU; Shenzhen Zeen Health Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: February 11, 2023
• First Submitted That Met QC Criteria: February 26, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Digital Therapy; Insomnia Disorder; Randomised Clinical Trial; Software-delivered CBT-I
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2022-65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No