Software-delivered CBT-I for Insomnia Disorder

Insomnia Disorder Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747963
• Other study ID #: 2022-65
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2023
• Source: Peking University Sixth Hospital
• Contact: Hongqiang Sun
• Phone: +8613911043951
• Email: sunhq[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

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.

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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Shenzhen Kangning Hospital	Shenzhen	Guangdong
China	The Second Affiliated Hospital of AFMU	Xi'an	Shaanxi

Sponsors (6)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality.	Baseline, post-intervention, follow-up (3 months after post-intervention)
Secondary	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)
Secondary	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)
Secondary	Life Quality	WHOQOL-BREF is used to evaluate the life quality.	Baseline, post-intervention, follow-up (3 months after post-intervention)