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Digital CBT-I for Insomnia Disorder (CrEDIT)

Primary Purpose

Insomnia Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

digital CBT-I

Sleep hygiene education

About this trial

This is an interventional treatment trial for Insomnia Disorder focused on measuring Insomnia, digital CBT, CBT-I

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital CBT-I

Sleep hygiene education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Change in sleep onset latency (SOL)

Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

Change in wake after sleep onset (WASO)

Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

Secondary Outcome Measures

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

Insomnia disorder remission based on the SCID Insomnia Module

structured interview to assess for Insomnia Disorder

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)

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

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

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

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

Change in sleep onset latency (SOL)

Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

Change in wake after sleep onset (WASO)

Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

Full Information

NCT ID

NCT05541055

First Posted

September 7, 2022

Last Updated

August 25, 2023

Sponsor

Big Health Inc.

Collaborators

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT05541055

Brief Title

Digital CBT-I for Insomnia Disorder

Acronym

CrEDIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 8, 2022 (Actual)

Primary Completion Date

May 15, 2023 (Actual)

Study Completion Date

August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Big Health Inc.

Collaborators

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia Disorder

Keywords

Insomnia, digital CBT, CBT-I

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

336 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Digital CBT-I

Arm Type

Experimental

Arm Description

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

Arm Title

Sleep hygiene education

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

digital CBT-I

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sleep hygiene education

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in the Insomnia Severity Index (ISI)

Description

Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity

Time Frame

From baseline to 10 weeks post-randomization

Title

Change in sleep onset latency (SOL)

Description

Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

Time Frame

From baseline to 10 weeks post-randomization

Title

Change in wake after sleep onset (WASO)

Description

Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

Time Frame

From baseline to 10 weeks post-randomization

Secondary Outcome Measure Information:

Title

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

Description

Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity

Time Frame

10, 16, and 24 weeks post-randomization

Title

Insomnia disorder remission based on the SCID Insomnia Module

Description

structured interview to assess for Insomnia Disorder

Time Frame

Week -1 compared to weeks 10, 16, and 24 post-randomization

Title

Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT)

Description

Each measured in minutes by daily sleep diaries (based on the Consensus Sleep Diary)

Time Frame

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

Title

Change in the Sleep Condition Indicator (SCI-8)

Description

Validated questionnaire; an 8-item scale with total scores between 0 and 32 where higher scores indicate better sleep

Time Frame

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

Title

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

Description

Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity

Time Frame

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

Title

Change in the Patient Health Questionnaire (PHQ-8)

Description

Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity

Time Frame

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

Title

Change in the Insomnia Severity Index (ISI)

Description

Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity

Time Frame

From baseline to weeks 16 and 24 post-randomization

Title

Change in sleep onset latency (SOL)

Description

Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

Time Frame

From baseline to weeks 16 and 24 post-randomization

Title

Change in wake after sleep onset (WASO)

Description

Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

Time Frame

From baseline to weeks 16 and 24 post-randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Digital CBT-I for Insomnia Disorder

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