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

A study testing WELT-IP in people with Insomnia, run by WELT corp at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Insomnia
What is being tested?: WELT-IP
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteSouth Korea
Study dates: 15 Dec 2021to 8 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Severance Hospital
Seoul, 03722

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions: Insomnia
Being tested: WELT-IP, Sham
Keywords: digital therapeutics
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WELT-IPDevice
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.
ShamDevice
Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.

Study groups in NCT05822999
Study group	Role	What they receive
WELT-IP	Experimental	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. Receives: Device: WELT-IP
Sham	Sham comparator	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. Receives: Device: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline (before using) to week 8 (after 6 weeks of using) 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.
Measured: 8 weeks

Secondary outcomes (14)

Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep efficiency (SE)
Sleep efficiency is calculated as percentage of Total sleep time/time in bed.
Measured: 8 weeks
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep quality (SQ)
Sleep quality ranges from 1 to 5, where higher score indicates better quality of sleep.
Measured: 8 weeks
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep onset latency (SOL)
Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed.
Measured: 8 weeks
Change from week 1 (before using) to week 8 (after 6 weeks of using) 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.
Measured: 8 weeks
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Total sleep time (TST)
Total sleep time is calculated as the total number of minutes that a person actually sleep.
Measured: 8 weeks
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Number of awakening (NOA)
Number of awakening is evaluated as the number of times a person wakes up after falling asleep.
Measured: 8 weeks
Change from baseline (before using) to week 8 (after 6 weeks of using) of Pittsburgh sleep quality index (PSQI)
Pittsburgh sleep quality index has ten questions. Total score ranges from 0 to 21, where higher scores indicate lower quality of sleep.
Measured: 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)
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.
Measured: 8 weeks
Change from baseline (before using) to week 8 (after 6 weeks of using) 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.
Measured: 8 weeks
Change from baseline (before using) to week 8 (after 6 weeks of using) 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.
Measured: 8 weeks
Change from baseline (before using) to week 8 (after 6 weeks of using) of Epworth sleepiness scale (ESS)
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.
Measured: 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
Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Measured: 14 weeks
Percentage of subjects achieving SE ≥ 85%
Measured: 8 weeks
Compliance (completion rate of lessons, for WELT-IP group only)
Compliance is evaluated as completion rate of lessons.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 20218 Jun 2022

First posted21 Apr 2023
Study start15 Dec 2021
Primary completion26 Apr 2022
Study completion8 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05822999
Sponsor's protocol ID: WCTP-I-B-01
Status last verified: Mar 2023
First submitted: 14 Mar 2023
Last updated: 21 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kabbani A, Passler M, Park K, Lee E, Lee Y, Jansen M, Moon DU. Culturally adapted digital cognitive behavioral therapy for insomnia in South Korea - a double-blind randomized controlled trial. Internet Interv. 2026 Mar 13;44:100933. doi: 10.1016/j.invent.2026.100933. eCollection 2026 Jun.
PubMed 41883996
Lee S, Park KM, Lee DH, Choi EC, Lee Y, Lee E. Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness. Yonsei Med J. 2025 Oct;66(10):657-665. doi: 10.3349/ymj.2024.0398.
PubMed 40992766

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blinded, Sham-controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Insomnia
ClinicalTrials.gov ID: NCT05822999
Acronym / sponsor ID: WCTP-I-B-01
Conditions: Insomnia
Keywords: digital therapeutics
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: WELT corpIndustry (pharma, biotech, devices)
Study start: 15 Dec 2021 (actual)
Primary completion: 26 Apr 2022 (actual)
Study completion: 8 Jun 2022 (actual)
First posted: 21 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
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.

Arm	Type	Receives
WELT-IP	Experimental	Device: WELT-IPEligible subjects were able to access WELT-IP (an investigational digital therapeutic) on a mobile device (iOS and Android) as scheduled to receive CBT-I.
Sham	Sham comparator	Device: ShamEligible 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.

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WELT-IPWELT-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.	Device	WELT-IP
ShamSham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.	Device	Sham

Primary outcome

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.

14 secondary outcomes

Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep efficiency (SE)
Time frame: 8 weeks
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep quality (SQ)
Time frame: 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
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Wake after sleep onset (WASO)
Time frame: 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
Change from week 1 (before using) to week 8 (after 6 weeks of using) of Number of awakening (NOA)
Time frame: 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
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
Change from baseline (before using) to week 8 (after 6 weeks of using) of Patient health questionnaire-9 (PHQ-9)
Time frame: 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
Change from baseline (before using) to week 8 (after 6 weeks of using) of Epworth sleepiness scale (ESS)
Time frame: 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
Percentage of subjects achieving SE ≥ 85%
Time frame: 8 weeks
Compliance (completion rate of lessons, for WELT-IP group only)
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
Derived from this study: PubMed 41883996Kabbani A, Passler M, Park K, Lee E, Lee Y, Jansen M, Moon DU. Culturally adapted digital cognitive behavioral therapy for insomnia in South Korea - a double-blind randomized controlled trial. Internet Interv. 2026 Mar 13;44:100933. doi: 10.1016/j.invent.2026.100933. eCollection 2026 Jun.
Derived from this study: PubMed 40992766Lee S, Park KM, Lee DH, Choi EC, Lee Y, Lee E. Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness. Yonsei Med J. 2025 Oct;66(10):657-665. doi: 10.3349/ymj.2024.0398.
Individual participant dataSharing planned: No

Related trials for Insomnia

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
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Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing WELT-IP in people with Insomnia, run by WELT corp at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline (before using) to week 8 (after 6 weeks of using) of Insomnia severity index (ISI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822999, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.