Insomnia DisorderCrEDITNCT05541055
Digital CBT-I for Insomnia Disorder
A study testing digital CBT-I and Sleep hygiene education in people with Insomnia Disorder, run by Big Health Inc. at 1 site in United States.
Trial summary
This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- digital CBT-I and Sleep hygiene education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 24 Aug 2023
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥22 years old
- Insomnia Disorder diagnosis
- Score ≤16 on the 8-item Sleep Condition Indicator
- > 30 minutes sleep onset latency (SOL); and/or > 30 minutes wake after sleep onset (WASO)
- Current resident of the USA
- Oral and written fluency in English
- Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form
Who cannot join
- Must not be currently receiving or be expecting to start CBT for insomnia during study participation, or have previously received CBT for insomnia in the past 12-months (self-report)
- If on psychoactive medication, including sleep medication, this must be stable for at least 5 half lives
- Past or present psychosis, schizophrenia, bipolar disorder, assessed by self-report and/or seizure disorder
- Occupation that requires alertness / caution to avoid accidents, for example long-haul driving, long distance bus driver, heavy machinery operator, air traffic controller
- Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT-I or SHE in the opinion of the investigator
- Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
- Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial
This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.
Read the detailed description
This study aims to examine the effectiveness of a fully-automated web and app-based digital CBT-I for insomnia compared to sleep hygiene education (SHE) in individuals with a diagnosis of insomnia disorder. Primary outcomes of interest include changes in insomnia severity, sleep onset latency, and wake after sleep onset throughout the course of the study.
- Conditions
- Insomnia Disorder
- Being tested
- digital CBT-I, Sleep hygiene education
- Keywords
- Insomnia, digital CBT, CBT-I
- 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.
digital CBT-IDevice
Also called Sleepio
A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia.
Sleep hygiene educationOther
Participants will be provided with sleep hygiene advice which will be delivered digitally all at once upon allocation to the SHE arm. Participants will be able to revisit content during the trial as they wish.
| Study group | Role | What they receive |
|---|---|---|
| Digital CBT-I | Experimental | Digitally-delivered CBT for insomnia accessed via web and/or mobile app Receives: Device: digital CBT-I |
| Sleep hygiene education | Active comparator | This group will receive access to sleep hygiene education delivered via digital written materials Receives: Other: Sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Insomnia Severity Index (ISI)
Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
Measured: From baseline to 10 weeks post-randomization
Change in sleep onset latency (SOL)
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Measured: From baseline to 10 weeks post-randomization
Change in wake after sleep onset (WASO)
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Measured: From baseline to 10 weeks post-randomization
Secondary outcomes (9)
Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI
Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
Measured: 10, 16, and 24 weeks post-randomization
Insomnia disorder remission based on the SCID Insomnia Module
structured interview to assess for Insomnia Disorder
Measured: Week -1 compared to weeks 10, 16, and 24 post-randomization
Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT)
Each measured in minutes by daily sleep diaries (based on the Consensus Sleep Diary)
Measured: From lead-in period to 10, 16, and 24 weeks post-randomization
Change in the Sleep Condition Indicator (SCI-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 32 where higher scores indicate better sleep
Measured: From baseline to weeks 10, 16, and 24 post-randomization
Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)
Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity
Measured: From baseline to weeks 10, 16, and 24 post-randomization
Change in the Patient Health Questionnaire (PHQ-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Measured: From baseline to weeks 10, 16 and 24 post-randomization
Change in the Insomnia Severity Index (ISI)
Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
Measured: From baseline to weeks 16 and 24 post-randomization
Change in sleep onset latency (SOL)
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Measured: From baseline to weeks 16 and 24 post-randomization
Change in wake after sleep onset (WASO)
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Measured: From baseline to weeks 16 and 24 post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start8 Nov 2022
- Primary completion15 May 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Big Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541055
- Sponsor's protocol ID
- BH-S-01
- Acronym
- CrEDIT
- Status last verified
- Apr 2024
- First submitted
- 7 Sep 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Prather AA, Krystal AD, Emsley R, Carl J, Ball T, Tarnai K, Aguilera A, Espie CA, Henry AL. The Effectiveness of Digital Cognitive Behavioral Therapy to Treat Insomnia Disorder in US Adults: Nationwide Decentralized Randomized Controlled Trial. JMIR Ment Health. 2025 Dec 4;12:e84323. doi: 10.2196/84323.
PubMed 41343796
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05541055
- Acronym / sponsor ID
- CrEDIT / BH-S-01
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia, digital CBT, CBT-I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Big Health Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 15 Sep 2022 (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.
This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.
Detailed description
This study aims to examine the effectiveness of a fully-automated web and app-based digital CBT-I for insomnia compared to sleep hygiene education (SHE) in individuals with a diagnosis of insomnia disorder. Primary outcomes of interest include changes in insomnia severity, sleep onset latency, and wake after sleep onset throughout the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital CBT-I | Experimental | Device: digital CBT-IDigitally-delivered CBT for insomnia accessed via web and/or mobile app |
| Sleep hygiene education | Active comparator | Other: Sleep hygiene educationThis group will receive access to sleep hygiene education delivered via digital written materials |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥22 years old
- Insomnia Disorder diagnosis
- Score ≤16 on the 8-item Sleep Condition Indicator
- > 30 minutes sleep onset latency (SOL); and/or > 30 minutes wake after sleep onset (WASO)
- Current resident of the USA
Key exclusion criteria (7 listed)
- Must not be currently receiving or be expecting to start CBT for insomnia during study participation, or have previously received CBT for insomnia in the past 12-months (self-report)
- If on psychoactive medication, including sleep medication, this must be stable for at least 5 half lives
- Past or present psychosis, schizophrenia, bipolar disorder, assessed by self-report and/or seizure disorder
- Occupation that requires alertness / caution to avoid accidents, for example long-haul driving, long distance bus driver, heavy machinery operator, air traffic controller
- Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT-I or SHE in the opinion of the investigator
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 |
|---|---|---|
| digital CBT-IAlso: SleepioA fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia. | Device | Digital CBT-I |
| Sleep hygiene educationParticipants will be provided with sleep hygiene advice which will be delivered digitally all at once upon allocation to the SHE arm. Participants will be able to revisit content during the trial as they wish. | Other | Sleep hygiene education |
Primary outcome
Change in the Insomnia Severity Index (ISI)
Time frame: From baseline to 10 weeks post-randomization
Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
Change in sleep onset latency (SOL)
Time frame: From baseline to 10 weeks post-randomization
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Change in wake after sleep onset (WASO)
Time frame: From baseline to 10 weeks post-randomization
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
9 secondary outcomes
Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI
Time frame: 10, 16, and 24 weeks post-randomization
Insomnia disorder remission based on the SCID Insomnia Module
Time frame: Week -1 compared to weeks 10, 16, and 24 post-randomization
Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT)
Time frame: From lead-in period to 10, 16, and 24 weeks post-randomization
Change in the Sleep Condition Indicator (SCI-8)
Time frame: From baseline to weeks 10, 16, and 24 post-randomization
Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: From baseline to weeks 10, 16, and 24 post-randomization
Change in the Patient Health Questionnaire (PHQ-8)
Time frame: From baseline to weeks 10, 16 and 24 post-randomization
Change in the Insomnia Severity Index (ISI)
Time frame: From baseline to weeks 16 and 24 post-randomization
Change in sleep onset latency (SOL)
Time frame: From baseline to weeks 16 and 24 post-randomization
Change in wake after sleep onset (WASO)
Time frame: From baseline to weeks 16 and 24 post-randomization
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 15 Apr 2024.
- Derived from this study: PubMed 41343796Prather AA, Krystal AD, Emsley R, Carl J, Ball T, Tarnai K, Aguilera A, Espie CA, Henry AL. The Effectiveness of Digital Cognitive Behavioral Therapy to Treat Insomnia Disorder in US Adults: Nationwide Decentralized Randomized Controlled Trial. JMIR Ment Health. 2025 Dec 4;12:e84323. doi: 10.2196/84323.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital CBT-I and Sleep hygiene education in people with Insomnia Disorder, run by Big Health Inc. at 1 site in United States.
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 7 inclusion and 7 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Change in the Insomnia Severity Index (ISI) (time frame: From baseline to 10 weeks post-randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05541055, which also lists 1 linked publication.
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 15 Apr 2024; AzTrials last refreshed its copy on 31 Oct 2026.