Insomnia DisorderNCT05747963
Software-delivered CBT-I for Insomnia Disorder
A study testing software-delivered CBT-I and online PE in people with Insomnia Disorder, run by Peking University Sixth Hospital at 5 sites in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- software-delivered CBT-I and online PE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 5 sitesChina
- Study dates
- 21 Mar 2023to 21 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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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 (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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
Peking University First Hospital
Beijing, Beijing Municipality
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Shenzhen Kangning Hospital
Shenzhen, Guangdong
The Second Affiliated Hospital of AFMU
Xi'an, Shaanxi
About this study
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.
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
- Being tested
- software-delivered CBT-I, online PE
- Keywords
- Insomnia Disorder, Software-delivered CBT-I, Randomised Clinical Trial, Digital Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
software-delivered CBT-IDevice
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 PEOther
Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: software-delivered CBT-I |
| online PE | Active comparator | Subjects in control group will receive information about insomnia and sleep health education content. Receives: Other: online PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-intervention, follow-up (3 months after post-intervention)
Secondary outcomes (7)
Insomnia Remission
Insomnia remission was evaluated by a masked assessor using a semi-structured interview.
Measured: Baseline, post-intervention, follow-up (3 months after post-intervention)
Insomnia Treatment Response
Insomnia treatment response was defined by a decrease in ISI by at least 8 points.
Measured: Baseline, post-intervention, follow-up (3 months after post-intervention)
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.
Measured: Baseline, post-intervention, follow-up (3 months after post-intervention)
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality.
Measured: Baseline, post-intervention, follow-up (3 months after post-intervention)
Depression
Patient Health Questionnaire-9 (PHQ-9) is used to evaluate the severity of depression.
Measured: Baseline, post-intervention, follow-up (3 months after post-intervention)
Anxiety
Generalized Anxiety Disorder Scale-7 (GAD-7) is used to evaluate the severity of anxiety.
Measured: Baseline, post-intervention, follow-up (3 months after post-intervention)
Life Quality
WHOQOL-BREF is used to evaluate the life quality.
Measured: Baseline, post-intervention, follow-up (3 months after post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start21 Mar 2023
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multicenter, parallel, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Zeen Health Technology Co., Ltd., Peking University First Hospital, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of AFMU, Shenzhen Kangning Hospital
- Responsible party
- Principal investigator, Hongqiang Sun, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747963
- Sponsor's protocol ID
- 2022-65
- Status last verified
- Aug 2024
- First submitted
- 11 Feb 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05747963
- Acronym / sponsor ID
- 2022-65
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia Disorder, Software-delivered CBT-I, Randomised Clinical Trial, Digital Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Zeen Health Technology Co., Ltd., Peking University First Hospital, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of AFMU, Shenzhen Kangning Hospital
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, multicenter, parallel, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| software-delivered CBT-I | Experimental | Device: software-delivered CBT-ISubjects 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. |
| online PE | Active comparator | Other: online PESubjects in control group will receive information about insomnia and sleep health education content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 ;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| software-delivered CBT-IThe 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. | Device | software-delivered CBT-I |
| online PESubjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account. | Other | online PE |
Primary outcome
The Change of Insomnia Severity from Baseline to Follow-up
Time frame: 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.
7 secondary outcomes
Insomnia Remission
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Insomnia Treatment Response
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Sleep Parameters Assessed by Sleep Diary
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Sleep Quality
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Depression
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Anxiety
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Life Quality
Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing software-delivered CBT-I and online PE in people with Insomnia Disorder, run by Peking University Sixth Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change of Insomnia Severity from Baseline to Follow-up (time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.