Digital CBT-I for Insomnia Disorder (CrEDIT)

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.

Study Overview

• Status: Completed
• Conditions: Insomnia Disorder
• Intervention / Treatment: Device: digital CBT-I; Other: Sleep hygiene education

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 Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital CBT-I; Digitally-delivered CBT for insomnia accessed via web and/or mobile app	Device: digital CBT-I; A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia.; Other Names: Sleepio
Active Comparator: Sleep hygiene education; This group will receive access to sleep hygiene education delivered via digital written materials	Other: Sleep hygiene education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10, 16, and 24 weeks post-randomization
Insomnia disorder remission based on the SCID Insomnia Module	structured interview to assess for Insomnia Disorder	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)	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	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	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	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	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	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	From baseline to weeks 16 and 24 post-randomization

Collaborators and Investigators

• Sponsor: Big Health Inc.
• Collaborators: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Insomnia; CBT-I; digital CBT
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: BH-S-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes