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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, 68 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 to week 7 (post-treatment) of Sleep efficiency(SE) | Sleep efficiency is calculated as percentage of Total sleep time/Time in bed. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 7 (post-treatment) of Sleep quality (SQ) | Sleep quality ranges from 1 to 5, where higher score indicates better quality of sleep. | 7 weeks |
| Change from baseline to week 7 (post-treatment) of Sleep onset latency (SOL) |
| Measure | Description | Time Frame |
|---|---|---|
| App Satisfaction Survey | 7 weeks | |
| Sleep Environment Survey | 7 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 |
|---|---|---|---|
| 40992766 | Derived | 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. |
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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 three 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 onset latency is evaluated as the time it takes a person to fall asleep after going to bed.
| 7 weeks |
| Change from baseline to week 7 (post-treatment) 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. | 7 weeks |
| Change from baseline to week 7 (post-treatment) of Total sleep time (TST) | Total sleep time is calculated as the total number of minutes that a person actually sleep. | 7 weeks |
| Change from baseline to week 7 (post-treatment) of Number of awakening (NOA) | Number of awakening is evaluated as the number of times a person wakes up after falling asleep. | 7 weeks |
| Change from baseline to week 7 (post-treatment) 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. | 7 weeks |
| Change from baseline to week 7 (post-treatment) 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 beliefs and attitudes toward sleep. | 7 weeks |
| Change from baseline to week 7 (post-treatment) 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. | 7 weeks |
| Change from baseline to week 7 (post-treatment) 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. | 7 weeks |
| Percentage of subjects achieving SE ≥ 85% | 7 weeks |
| Compliance (completion rate of lessons, for WELT-IP group only) | Compliance is evaluated as completion rate of lessons. | 7 weeks |
Activity data is evaluated as change of number of steps from baseline to week 7.
| 7 weeks |
| D001523 |
| Mental Disorders |