Digital CBT-I for Insomnia Disorder

NCT ID: NCT05541055

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2023-08-24

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Digital CBT-I

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

Group Type: EXPERIMENTAL

digital CBT-I

Intervention Type: DEVICE

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

Sleep hygiene education

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

Group Type: ACTIVE_COMPARATOR

Sleep hygiene education

Intervention Type: 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.

Interventions

digital CBT-I

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Sleepio

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Big Health Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

BH-S-01

Identifier Type: -

Identifier Source: org_study_id