Clinical trial NCT05747963: 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
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Disorder
Keywords: Insomnia Disorder
Software-delivered CBT-I
Randomised Clinical Trial
Digital Therapy
Lead sponsor: Peking University Sixth Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen Zeen Health Technology Co., Ltd.
name: Peking University First Hospital
name: Sichuan Provincial People's Hospital
name: The Second Affiliated Hospital of AFMU
name: Shenzhen Kangning Hospital
First posted: 2023-02-28
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, multicenter, parallel, randomized controlled trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Change of Insomnia Severity from Baseline to Follow-up
timeFrame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Secondary outcomes:
measure: Insomnia Remission
timeFrame: Baseline, post-intervention, follow-up (3 months after post-intervention)
measure: Insomnia Treatment Response
timeFrame: Baseline, post-intervention, follow-up (3 months after post-intervention)
measure: Sleep Parameters Assessed by Sleep Diary
timeFrame: Baseline, post-intervention, follow-up (3 months after post-intervention)
measure: Sleep Quality
timeFrame: Baseline, post-intervention, follow-up (3 months after post-intervention)
measure: Depression
timeFrame: Baseline, post-intervention, follow-up (3 months after post-intervention)
measure: Anxiety
timeFrame: Baseline, post-intervention, follow-up (3 months after post-intervention)
measure: Life Quality
timeFrame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Other outcomes:
measure: Adverse Events
timeFrame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Shenzhen
country: China
facility: Shenzhen Kangning Hospital
state: Guangdong
city: Xi'an
country: China
facility: The Second Affiliated Hospital of AFMU
state: Shaanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References: