Software-delivered CBT-I for Insomnia Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2024-03-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Insomnia Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, multicenter, parallel, randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

software-delivered CBT-I

Intervention Type 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.

online PE

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

Group Type ACTIVE_COMPARATOR

online PE

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

online PE

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No