Clinical trial NCT05822999: Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)
Official title: A Multicenter, Randomized, Double-blinded, Sham-controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: digital therapeutics
Lead sponsor: WELT corp
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline (before using) to week 8 (after 6 weeks of using) of Insomnia severity index (ISI)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep efficiency (SE)
timeFrame: 8 weeks
measure: Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep quality (SQ)
timeFrame: 8 weeks
measure: Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep onset latency (SOL)
timeFrame: 8 weeks
measure: Change from week 1 (before using) to week 8 (after 6 weeks of using) of Wake after sleep onset (WASO)
timeFrame: 8 weeks
measure: Change from week 1 (before using) to week 8 (after 6 weeks of using) of Total sleep time (TST)
timeFrame: 8 weeks
measure: Change from week 1 (before using) to week 8 (after 6 weeks of using) of Number of awakening (NOA)
timeFrame: 8 weeks
measure: Change from baseline (before using) to week 8 (after 6 weeks of using) of Pittsburgh sleep quality index (PSQI)
timeFrame: 8 weeks
measure: Change from baseline (before using) to week 8 (after 6 weeks of using) of Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16)
timeFrame: 8 weeks
measure: Change from baseline (before using) to week 8 (after 6 weeks of using) of Patient health questionnaire-9 (PHQ-9)
timeFrame: 8 weeks
measure: Change from baseline (before using) to week 8 (after 6 weeks of using) of Generalized anxiety disorder-7 item scale (GAD-7)
timeFrame: 8 weeks
measure: Change from baseline (before using) to week 8 (after 6 weeks of using) of Epworth sleepiness scale (ESS)
timeFrame: 8 weeks
measure: Change from baseline (before using) to week 14 (after 6 weeks from close out visit) of Insomnia severity index (ISI) for WELT-IP group
timeFrame: 14 weeks
measure: Percentage of subjects achieving SE ≥ 85%
timeFrame: 8 weeks
measure: Compliance (completion rate of lessons, for WELT-IP group only)
timeFrame: 8 weeks
Other outcomes:
measure: App Satisfaction Survey (for WELT-IP group only)
timeFrame: 8 weeks
measure: Sleep Environment Survey
timeFrame: 8 weeks
measure: Activity data from mobile device
timeFrame: 8 weeks
measure: EuroQol 5 dimensions 5 level (EQ-5D-5L) Survey
timeFrame: 8 weeks
measure: EuroQol-visual analogue scales (EQ-VAS) Survey
timeFrame: 8 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: