Software-delivered CBT-I for Insomnia Disorder

NCT05747963 | Completed DMC

• 1 other identifier: 2022-65
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 5

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.

Conditions

Insomnia Disorder

Keywords

Insomnia Disorder; Software-delivered CBT-I; Randomised Clinical Trial; Digital Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Insomnia Remission

  Baseline, post-intervention, follow-up (3 months after post-intervention)

• Insomnia Treatment Response

  Baseline, post-intervention, follow-up (3 months after post-intervention)

• Sleep Parameters Assessed by Sleep Diary

  Baseline, post-intervention, follow-up (3 months after post-intervention)

• Sleep Quality

  Baseline, post-intervention, follow-up (3 months after post-intervention)

• Depression

  Baseline, post-intervention, follow-up (3 months after post-intervention)

Other Outcomes (1)

• Adverse Events

  Baseline, post-intervention, follow-up (3 months after post-intervention)

Study Arms (2)

software-delivered CBT-I

EXPERIMENTAL

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

online PE

ACTIVE COMPARATOR

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

Other: online PE

Interventions

software-delivered CBT-I DEVICE

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.

software-delivered CBT-I

online PE OTHER

Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account.

online PE

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (5)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Shenzhen Kangning Hospital

Shenzhen, Guangdong, China

Location

The Second Affiliated Hospital of AFMU

Xi'an, Shaanxi, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, multicenter, parallel, randomized controlled trial

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: February 28, 2023
• Study Start: March 21, 2023
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)