Digital CBT-I for Insomnia Disorder

NCT05541055 | Completed DMC FDA Device

• 1 other identifier: BH-S-01
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia Disorder

Keywords

Insomnia; digital CBT; CBT-I

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  From baseline to 10 weeks post-randomization

Secondary Outcomes (9)

• Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI

  10, 16, and 24 weeks post-randomization

• Insomnia disorder remission based on the SCID Insomnia Module

  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)

  From lead-in period to 10, 16, and 24 weeks post-randomization

• Change in the Sleep Condition Indicator (SCI-8)

  From baseline to weeks 10, 16, and 24 post-randomization

• Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)

  From baseline to weeks 10, 16, and 24 post-randomization

Study Arms (2)

Digital CBT-I

EXPERIMENTAL

Digitally-delivered CBT for insomnia accessed via web and/or mobile app

Device: digital CBT-I

Sleep hygiene education

ACTIVE COMPARATOR

This group will receive access to sleep hygiene education delivered via digital written materials

Other: Sleep hygiene education

Interventions

digital CBT-I DEVICE

A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia.

Also known as: Sleepio

Digital CBT-I

Sleep hygiene education OTHER

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.

Sleep hygiene education

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Big Health Inc.: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 41343796 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 15, 2022
• Study Start: November 8, 2022
• Primary Completion: May 15, 2023
• Study Completion: August 24, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)