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Completed

NCT Number: NCT05809544

Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-02)

The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital therapeutics.

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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

Severance Hospital

Seoul, 03722, South Korea

About this study

This was a randomized, double-blinded, sham-controlled trial. Overall, 68 subjects were randomized into the following groups:

  • WELT-IP group: WELT-IP (insomnia digital therapeutics) use
  • Control group: sham app use Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for insomnia, if applicable, including pharmacotherapy. After screening of sleep diary, subjects were randomized and in WELT-IP group used WELT-IP and subjects in control group used a sham for a period of 6 weeks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • DSM-5 insomnia patient
  • SE (sleep efficiency) <80%
  • completing screening sleep diary of 7 consecutive days
  • ISI of 8 or above
  • 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

Treatment and study plan

WELT-IP

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.

SHAM

Device

Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.

Primary outcomes

  1. Change from baseline to week 7 (post-treatment) of Sleep efficiency(SE)

    Time frame: 7 weeks

    Sleep efficiency is calculated as percentage of Total sleep time/Time in bed.

Secondary outcomes

  1. Change from baseline to week 7 (post-treatment) of Sleep quality (SQ)

    Time frame: 7 weeks

    Sleep quality ranges from 1 to 5, where higher score indicates better quality of sleep.

  2. Change from baseline to week 7 (post-treatment) of Sleep onset latency (SOL)

    Time frame: 7 weeks

    Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed.

  3. Change from baseline to week 7 (post-treatment) of Wake after sleep onset (WASO)

    Time frame: 7 weeks

    Wake after sleep onset is calculated as the total number of minutes that a person is awake after initially falling asleep.

  4. Change from baseline to week 7 (post-treatment) of Total sleep time (TST)

    Time frame: 7 weeks

    Total sleep time is calculated as the total number of minutes that a person actually sleep.

  5. Change from baseline to week 7 (post-treatment) of Number of awakening (NOA)

    Time frame: 7 weeks

    Number of awakening is evaluated as the number of times a person wakes up after falling asleep.

  6. Change from baseline to week 7 (post-treatment) of Insomnia severity index (ISI)

    Time frame: 7 weeks

    Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.

  7. Change from baseline to week 7 (post-treatment) of Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16)

    Time frame: 7 weeks

    Dysfunctional beliefs and attitudes about sleep-16 has sixteen questions. Responses can range from 0 to 10, where higher scores indicate more irrational beliefs and attitudes toward sleep.

  8. Change from baseline to week 7 (post-treatment) of Patient health questionnaire-9 (PHQ-9)

    Time frame: 7 weeks

    Patient health questionnaire-9 has nine questions. Total score ranges from 0 to 27, where higher scores indicate more acute symptoms of depression.

  9. Change from baseline to week 7 (post-treatment) of Generalized anxiety disorder-7 item scale (GAD-7)

    Time frame: 7 weeks

    Generalized anxiety disorder-7 item scale has seven questions. Total score ranges from 0 to 21, where higher scores indicate more acute symptoms of anxiety.

  10. Percentage of subjects achieving SE ≥ 85%

    Time frame: 7 weeks

  11. Compliance (completion rate of lessons, for WELT-IP group only)

    Time frame: 7 weeks

    Compliance is evaluated as completion rate of lessons.

Other outcomes

  1. App Satisfaction Survey

    Time frame: 7 weeks

  2. Sleep Environment Survey

    Time frame: 7 weeks

  3. Activity data from mobile device

    Time frame: 7 weeks

    Activity data is evaluated as change of number of steps from baseline to week 7.

Sponsors and collaborators

Lead sponsor

WELT corp

Industry

Registry information

Official study title

A Randomized, Double-blinded, Sham-controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Insomnia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

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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