Software-delivered CBT-I for Insomnia Disorder
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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.
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| Active Comparator: online PE Subjects in control group will receive information about insomnia and sleep health education content. |
Other: Online PE
Subjects in control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account.
|
Outcome Measures
Primary Outcome Measures
- The Change of Insomnia Severity from Baseline to Follow-up [Baseline, post-intervention, follow-up (3 months after post-intervention)]
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.
Secondary Outcome Measures
- Insomnia Remission [Baseline, post-intervention, follow-up (3 months after post-intervention)]
Insomnia remission was evaluated by a masked assessor using a semi-structured interview.
- Insomnia Treatment Response [Baseline, post-intervention, follow-up (3 months after post-intervention)]
Insomnia treatment response was defined by a decrease in ISI by at least 8 points.
- Sleep Parameters Assessed by Sleep Diary [Baseline, post-intervention, follow-up (3 months after post-intervention)]
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.
- Sleep Quality [Baseline, post-intervention, follow-up (3 months after post-intervention)]
Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality.
- Depression [Baseline, post-intervention, follow-up (3 months after post-intervention)]
Patient Health Questionnaire-9 (PHQ-9) is used to evaluate the severity of depression.
- Anxiety [Baseline, post-intervention, follow-up (3 months after post-intervention)]
Generalized Anxiety Disorder Scale-7 (GAD-7) is used to evaluate the severity of anxiety.
- Life Quality [Baseline, post-intervention, follow-up (3 months after post-intervention)]
WHOQOL-BREF is used to evaluate the life quality.
Other Outcome Measures
- Adverse Events [Baseline, post-intervention, follow-up (3 months after post-intervention)]
Adverse events will be recorded throughout this trial for evaluating the safety of software.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged ≥18 years old, no gender limitation;
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Own a mobile-phone, access the Internet, and be skilled in using software;
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Meet the diagnostic criteria of insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);
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Insomnia symptoms appear at least 3 nights per week and last for at least 3 months;
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ISI scores ≥ 12 ;
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Volunteer to participate in this experiment and sign a written informed consent.
Exclusion Criteria:
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Generalized Anxiety Disorder Scale-7 (GAD-7) scores ≥ 15;
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Patients Health Questionnaire-9 (PHQ-9) scores ≥ 20;
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Current thoughts of suicide or self-injury (defined as PHQ-9 9th item score ≥ 1);
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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.
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Current diagnosed neurological or mental illness (major depressive disorder, bipolar disorder, epilepsy, schizophrenia, etc.) that may affect sleep;
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Diagnoses of other untreated sleep disorders, such as obstructive sleep apnea, restless leg syndrome (RLS);
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Usual bedtime (when the subject attempts to fall asleep) is earlier than 8 p.m. or later than 2 a.m., or usual waking time is earlier than 4 a.m. or later than 10 a.m.
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Alcohol or drug abusers (other than nicotine dependence) in the past year;
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Pregnant or lactating women;
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Undergoing systematic psychotherapy within the past 3 months;
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Undergoing other cognitive behavioral therapy for sleep disorders;
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Unstable usage of medication regimens that affect sleep (changes in type, dosage and method of use within the past 1 month);
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Night shift workers, travelers across time zones;
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Subjects who have not responded to previous CBT-I;
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Other conditions deemed unsuitable for clinical trials by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Sixth Hospital | Beijing | Beijing | China | 100191 |
| 2 | Peking University First Hospital | Beijing | Beijing | China | |
| 3 | Shenzhen Kangning Hospital | Shenzhen | Guangdong | China | |
| 4 | The Second Affiliated Hospital of AFMU | Xi'an | Shaanxi | China | |
| 5 | Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
Sponsors and Collaborators
- Peking University Sixth Hospital
- Shenzhen Zeen Health Technology Co., Ltd.
- Peking University First Hospital
- Sichuan Provincial People's Hospital
- The Second Affiliated Hospital of AFMU
- Shenzhen Kangning Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-65