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: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
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 was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.
Severance Hospital
Seoul, South Korea
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.
Time frame: 7 weeks
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.
Time frame: 7 weeks
Change from baseline to week 7 (post-treatment) of Sleep onset latency (SOL)
Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 weeks
Percentage of subjects achieving SE ≥ 85%
Time frame: 7 weeks
Compliance (completion rate of lessons, for WELT-IP group only)
Compliance is evaluated as completion rate of lessons.
Time frame: 7 weeks