Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-02)

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Device: WELT-IP; Device: Sham

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
App Satisfaction Survey		7 weeks
Sleep Environment Survey		7 weeks
Activity data from mobile device	Activity data is evaluated as change of number of steps from baseline to week 7.	7 weeks

Collaborators and Investigators

• Sponsor: WELT corp

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2022
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: April 9, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: digital therapeutics
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: WCTP-I-B-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No