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Completed

NCT Number: NCT06339853

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

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Severance Hospital

Seoul, 120-752, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 19 to 65 years old
  • DSM-5 insomnia disorder patient
  • ISI ≥11
  • Capable of using mobile device and application

Exclusion criteria

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

Treatment and study plan

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

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.

Primary outcomes

  1. Change from baseline to week 9 (post-treatment) of ISI

    Time frame: 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 outcomes

  1. Secondary Outcome - Changes from baseline to week 9 of SE

    Time frame: 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.

  2. Changes from baseline to week 9 of SOL.

    Time frame: 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.

  3. Changes from baseline to week 9 of WASO.

    Time frame: 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.

  4. Changes from baseline to week 9 of PHQ-9.

    Time frame: 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.

  5. Changes from baseline to week 9 of GAD-7.

    Time frame: 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.

  6. Changes from baseline to week 9 of compliance.

    Time frame: 9 weeks

    Compliance (completion rate or lessons) Compliance is evaluated as completion rate of lessons.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2024
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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