Digital CBT-I for Insomnia Disorder

Insomnia Disorder Clinical Trial

— CrEDIT  

Official title:

Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05541055
• Other study ID #: BH-S-01
• Status: Completed
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: August 24, 2023

Study information

• Verified date: April 2024
• Source: Big Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: August 24, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• digital CBT-I
A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia.

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Big Health Inc.	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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