Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Device: WELT-IP
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, double-blinded design, with seven points of measurement. The subjects will receive either the WELT-IP app or sham app.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WELT-IP<br>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. | Device: WELT-IP<br>* 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.<br>|
| Sham Comparator: Sham<br>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. | Device: Sham<br>* Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital therapeutics