Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Device: WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)

• Registration Number: NCT06339853
• Lead Sponsor: Yonsei University

Brief Summary

The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients

Detailed Description

The investigators intend to conduct a single-arm clinical trial. Following voluntary consent during the screening visit, participants will undergo screening procedures. The screening process will proceed step by step, evaluating selection/exclusion criteria through assessments such as the Mini International Neuropsychiatric Interview (MINI), Columbia Suicide Severity Rating Scale (C-SSRS), etc. Participants who meet the selection criteria and do not meet the exclusion criteria will use the DTx app for 8 weeks. Surveys conducted after app installation (Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), and a sleep environment questionnaire) will serve as the baseline.

During the clinical trial period, sleep diaries and compliance (lesson completion rate) (applicable only to the experimental group) will be collected through the app. Sleep diaries will be used to evaluate sleep metrics such as sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), etc.

For the experimental group, assessments as per the protocol will be conducted at baseline (Visit 1), and safety (adverse events) evaluation and termination of app usage will occur at 9 weeks (Visit 2).

Study Timeline

• Study Start: 2023-09-07
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-24
• Last Update Submitted: 2024-03-24
• Study First Posted: 2024-04-01
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Individuals aged 19 to 65 years old
2. DSM-5 insomnia disorder patient
3. ISI ≥11
4. Capable of using mobile device and application

Exclusion Criteria

1. currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)
2. sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)
3. progressive and active medical conditions
4. received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months
5. major psychiatric illness as assessed through MINI
6. suicide risk as assessed through C-SSRS
7. having occupational risk due to sleep restriction
8. shift workers
9. PHQ-9 of 20 or above
10. Individuals who have actually slept less than an average of 5 hours per night over the past month
11. Pregnant women or individuals planning pregnancy during the clinical trial period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WELT-IP	WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)	Eligible subjects were able to access WELT-IP (an investigational digital therapeutic) on a mobile device (iOS and Android) as scheduled to receive cognitive behavioral therapy for insomnia (CBT-I). To collect sleep and environmental data, participants will wear the wearable devices, either (1) Apple Watch (Apple Watch Series 8 41mm (GPS)) or Galaxy Watch 5 40mm (Model: SM-R900NZAAKOO), and (2) Oura Ring (Model: Heritage), during the WELT-IP treatment period.

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 9 (post-treatment) of ISI	9 weeks	Change from baseline to week 9 (post-treatment) of ISI. ISI has 7 questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome - Changes from baseline to week 9 of SE	9 weeks	Change from baseline to week 9 (post-treatment) of SE. Sleep efficiency is calculated as percentage of total sleep time/time in bed.
Changes from baseline to week 9 of SOL.	9 weeks	Change from baseline to week 9 (post-treatment) of SOL. Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed.
Changes from baseline to week 9 of WASO.	9 weeks	Change from baseline to week 9 (post-treatment) of WASO. WASO is calculated as the total number of minutes that a person is awake after initially falling asleep.
Changes from baseline to week 9 of PHQ-9.	9 weeks	Change from baseline to week 9 (post-treatment) of PHQ-9. PHQ-9 has nine questions. Total score ranges from 0 to 27, where higher scores indicate more acute symptoms of depression.
Changes from baseline to week 9 of GAD-7.	9 weeks	Change from baseline to week 9 (post-treatment) of GAD-7. GAD-7 has seven questions. Total score ranges from 0 to 21, where higher scores indicate more acute symptoms of anxiety.
Changes from baseline to week 9 of compliance.	9 weeks	Compliance (completion rate or lessons) Compliance is evaluated as completion rate of lessons.

Trial Locations

Locations (1)

Department of Psychiatry, Severance Hospital; 🇰🇷 Seoul,, Korea, Republic of