Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)
- Conditions
- Insomnia
- Registration Number
- NCT05822999
- Lead Sponsor
- WELT corp
- Brief Summary
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.
- Detailed Description
This was a randomized, double-blinded, sham-controlled trial. Overall, 52 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- DSM-5 insomnia patient
- ISI of 8 or above
- for 7 days before baseline visit (Visit 2), completing sleep diary for more than 4 days in the guidelines
- capable of using mobile device and application
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline (before using) to week 8 (after 6 weeks of using) of Insomnia severity index (ISI) 8 weeks Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
- Secondary Outcome Measures
Name Time Method Change from baseline (before using) to week 8 (after 6 weeks of using) of Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16) 8 weeks Dysfunctional beliefs and attitudes about sleep-16 has sixteen questions. Responses can range from 0 to 10, where higher scores indicate more irrational belief and attitude toward sleep.
Change from baseline (before using) to week 8 (after 6 weeks of using) of Pittsburgh sleep quality index (PSQI) 8 weeks Pittsburgh sleep quality index has ten questions. Total score ranges from 0 to 21, where higher scores indicate lower quality of sleep.
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep efficiency (SE) 8 weeks Sleep efficiency is calculated as percentage of Total sleep time/time in bed.
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep quality (SQ) 8 weeks Sleep quality ranges from 1 to 5, where higher score indicates better quality of sleep.
Change from baseline (before using) to week 14 (after 6 weeks from close out visit) of Insomnia severity index (ISI) for WELT-IP group 14 weeks Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep onset latency (SOL) 8 weeks Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed.
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Wake after sleep onset (WASO) 8 weeks Wake after sleep onset is calculated as the total number of minutes that a person is awake after initially falling asleep.
Change from baseline (before using) to week 8 (after 6 weeks of using) of Patient health questionnaire-9 (PHQ-9) 8 weeks Patient health questionnaire-9 has nine questions. Total score ranges from 0 to 27, where higher scores indicate more acute symptoms of depression.
Change from baseline (before using) to week 8 (after 6 weeks of using) of Epworth sleepiness scale (ESS) 8 weeks Epworth sleepiness scale has eight questions. Total score ranges from 0 to 24. A total score of 10 or less is evaluated as normal. A total score of 11 to 15 is evaluated as significant sleepiness. A total score of 16 or more is evaluated as pathological sleepiness.
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Total sleep time (TST) 8 weeks Total sleep time is calculated as the total number of minutes that a person actually sleep.
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Number of awakening (NOA) 8 weeks Number of awakening is evaluated as the number of times a person wakes up after falling asleep.
Change from baseline (before using) to week 8 (after 6 weeks of using) of Generalized anxiety disorder-7 item scale (GAD-7) 8 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.
Percentage of subjects achieving SE ≥ 85% 8 weeks Compliance (completion rate of lessons, for WELT-IP group only) 8 weeks Compliance is evaluated as completion rate of lessons.
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital🇰🇷Seoul, Korea, Republic of