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

April 9, 2023 updated by: WELT corp

A Multicenter, 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

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 (before using) to week 8 (after 6 weeks of using) of Insomnia severity index (ISI)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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
Time Frame: 14 weeks
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%
Time Frame: 8 weeks
8 weeks
Compliance (completion rate of lessons, for WELT-IP group only)
Time Frame: 8 weeks
Compliance is evaluated as completion rate of lessons.
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
App Satisfaction Survey (for WELT-IP group only)
Time Frame: 8 weeks
8 weeks
Sleep Environment Survey
Time Frame: 8 weeks
8 weeks
Activity data from mobile device
Time Frame: 8 weeks
Activity data is evaluated as change of number of steps from baseline to week 8.
8 weeks
EuroQol 5 dimensions 5 level (EQ-5D-5L) Survey
Time Frame: 8 weeks
EuroQol 5 dimensions 5 level comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
8 weeks
EuroQol-visual analogue scales (EQ-VAS) Survey
Time Frame: 8 weeks
EuroQol-visual analogue scales records the self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WELT corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

April 26, 2022

Study Completion (Actual)

June 8, 2022

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

April 9, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCTP-I-B-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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