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COMPLETEDNA

Digital CBT-I for Insomnia Disorder

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

NCT05541055•Big Health Inc.

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.

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

November 8, 2022

Primary Completion Date

May 15, 2023

Completion Date

August 24, 2023

Last Updated

April 15, 2024

Enrollment

336

ACTUAL participants

Conditions

Insomnia Disorder

Interventions

digital CBT-I

DEVICE

Sleep hygiene education

OTHER

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Posttraumatic Stress DisorderInsomnia Disorder

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RECRUITINGNA

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COMPLETEDPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Digital CBT-I for Insomnia Disorder

Inclusion Criteria

Exclusion Criteria

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

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Changed Serum Levels of Sirtuin1 and Sirtuin3 and Their Correlations With Sleep Quality and Cognitive Function in the Patients With Chronic Insomnia Disorder

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