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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.
This was a randomized, double-blinded, sham-controlled trial. Overall, 52 subjects were randomized into the following groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WELT-IP | Experimental | Eligible subjects were able to access WELT-IP (an investigational digital therapeutic) on a mobile device (iOS and Android) as scheduled to receive CBT-I. |
|
| Sham | Sham Comparator | Eligible subjects were able to access a sham app downloaded on a mobile device (iOS and Android) which included sleep diary and general content regarding sleep. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (before using) to week 8 (after 6 weeks of using) of Insomnia severity index (ISI) | Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep efficiency (SE) | Sleep efficiency is calculated as percentage of Total sleep time/time in bed. | 8 weeks |
| Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep quality (SQ) |
| Measure | Description | Time Frame |
|---|---|---|
| App Satisfaction Survey (for WELT-IP group only) | 8 weeks | |
| Sleep Environment Survey | 8 weeks | |
| Activity data from mobile device |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41883996 | Derived | Kabbani A, Passler M, Park K, Lee E, Lee Y, Jansen M, Moon DU. Culturally adapted digital cognitive behavioral therapy for insomnia in South Korea - a double-blind randomized controlled trial. Internet Interv. 2026 Mar 13;44:100933. doi: 10.1016/j.invent.2026.100933. eCollection 2026 Jun. | |
| 40992766 | Derived |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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This is a randomized, double-blinded design, with seven points of measurement. The subjects will receive either the WELT-IP app or sham app.
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double-blinded
|
| 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. |
|
Sleep quality ranges from 1 to 5, where higher score indicates better quality of sleep. |
| 8 weeks |
| Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep onset latency (SOL) | Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed. | 8 weeks |
| Change from week 1 (before using) to week 8 (after 6 weeks of using) of Wake after sleep onset (WASO) | Wake after sleep onset is calculated as the total number of minutes that a person is awake after initially falling asleep. | 8 weeks |
| Change from week 1 (before using) to week 8 (after 6 weeks of using) of Total sleep time (TST) | Total sleep time is calculated as the total number of minutes that a person actually sleep. | 8 weeks |
| Change from week 1 (before using) to week 8 (after 6 weeks of using) of Number of awakening (NOA) | Number of awakening is evaluated as the number of times a person wakes up after falling asleep. | 8 weeks |
| Change from baseline (before using) to week 8 (after 6 weeks of using) of Pittsburgh sleep quality index (PSQI) | Pittsburgh sleep quality index has ten questions. Total score ranges from 0 to 21, where higher scores indicate lower quality of sleep. | 8 weeks |
| Change from baseline (before using) to week 8 (after 6 weeks of using) of Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16) | 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. | 8 weeks |
| Change from baseline (before using) to week 8 (after 6 weeks of using) of Patient health questionnaire-9 (PHQ-9) | Patient health questionnaire-9 has nine questions. Total score ranges from 0 to 27, where higher scores indicate more acute symptoms of depression. | 8 weeks |
| Change from baseline (before using) to week 8 (after 6 weeks of using) of Generalized anxiety disorder-7 item scale (GAD-7) | 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. | 8 weeks |
| Change from baseline (before using) to week 8 (after 6 weeks of using) of Epworth sleepiness scale (ESS) | 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. | 8 weeks |
| Change from baseline (before using) to week 14 (after 6 weeks from close out visit) of Insomnia severity index (ISI) for WELT-IP group | Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia. | 14 weeks |
| Percentage of subjects achieving SE ≥ 85% | 8 weeks |
| Compliance (completion rate of lessons, for WELT-IP group only) | Compliance is evaluated as completion rate of lessons. | 8 weeks |
Activity data is evaluated as change of number of steps from baseline to week 8. |
| 8 weeks |
| EuroQol 5 dimensions 5 level (EQ-5D-5L) Survey | EuroQol 5 dimensions 5 level comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | 8 weeks |
| EuroQol-visual analogue scales (EQ-VAS) Survey | EuroQol-visual analogue scales records the self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | 8 weeks |
| Lee S, Park KM, Lee DH, Choi EC, Lee Y, Lee E. Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness. Yonsei Med J. 2025 Oct;66(10):657-665. doi: 10.3349/ymj.2024.0398. |
| D001523 |
| Mental Disorders |