Clinical trial NCT05809544: Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-02)
Official title: A 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: 2023-04-12
Enrollment: 68
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 three 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, 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.

Eligibility criteria: Inclusion Criteria:

* DSM-5 insomnia patient
* SE (sleep efficiency) \<80%
* completing screening sleep diary of 7 consecutive days
* ISI of 8 or above
* 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 to week 7 (post-treatment) of Sleep efficiency(SE)
timeFrame: 7 weeks
Secondary outcomes:
measure: Change from baseline to week 7 (post-treatment) of Sleep quality (SQ)
timeFrame: 7 weeks
measure: Change from baseline to week 7 (post-treatment) of Sleep onset latency (SOL)
timeFrame: 7 weeks
measure: Change from baseline to week 7 (post-treatment) of Wake after sleep onset (WASO)
timeFrame: 7 weeks
measure: Change from baseline to week 7 (post-treatment) of Total sleep time (TST)
timeFrame: 7 weeks
measure: Change from baseline to week 7 (post-treatment) of Number of awakening (NOA)
timeFrame: 7 weeks
measure: Change from baseline to week 7 (post-treatment) of Insomnia severity index (ISI)
timeFrame: 7 weeks
measure: Change from baseline to week 7 (post-treatment) of Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16)
timeFrame: 7 weeks
measure: Change from baseline to week 7 (post-treatment) of Patient health questionnaire-9 (PHQ-9)
timeFrame: 7 weeks
measure: Change from baseline to week 7 (post-treatment) of Generalized anxiety disorder-7 item scale (GAD-7)
timeFrame: 7 weeks
measure: Percentage of subjects achieving SE ≥ 85%
timeFrame: 7 weeks
measure: Compliance (completion rate of lessons, for WELT-IP group only)
timeFrame: 7 weeks
Other outcomes:
measure: App Satisfaction Survey
timeFrame: 7 weeks
measure: Sleep Environment Survey
timeFrame: 7 weeks
measure: Activity data from mobile device
timeFrame: 7 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: