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

NCT ID: NCT06339853

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-07
• Study Completion Date: 2024-02-29

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).

Conditions

Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WELT-IP

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.

Group Type: EXPERIMENTAL

WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)

Intervention Type: DEVICE

WELT-IP (an investigational digital therapeutic) is an CBT-I based intervention designed to treat insomnia, conducted in 6 sessions. It is a comprehensive program delivering sleep restriction, stimulation control, muscle relaxation, cognitive treatment, and sleep hygiene education. Main features are sleep diary, sleep reports, daily lessons of CBT-I, muscle relaxation techniques, and cognitive intervention through chatbot. By using WELT-IP simultaneously with wearing an Apple Watch/Galaxy Watch and Oura Ring, sleep and environmental data can be collected.

Interventions

WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)

WELT-IP (an investigational digital therapeutic) is an CBT-I based intervention designed to treat insomnia, conducted in 6 sessions. It is a comprehensive program delivering sleep restriction, stimulation control, muscle relaxation, cognitive treatment, and sleep hygiene education. Main features are sleep diary, sleep reports, daily lessons of CBT-I, muscle relaxation techniques, and cognitive intervention through chatbot. By using WELT-IP simultaneously with wearing an Apple Watch/Galaxy Watch and Oura Ring, sleep and environmental data can be collected.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Psychiatry, Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1-2023-0023

Identifier Type: -

Identifier Source: org_study_id