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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822999
• Other study ID #: WCTP-I-B-01
• Status: Completed
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: March 2023
• Source: WELT corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 8, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
WELT corp

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	App Satisfaction Survey (for WELT-IP group only)		8 weeks
Other	Sleep Environment Survey		8 weeks
Other	Activity data from mobile device	Activity data is evaluated as change of number of steps from baseline to week 8.	8 weeks
Other	EuroQol 5 dimensions 5 level (EQ-5D-5L) Survey	EuroQol 5 dimensions 5 level comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	8 weeks
Other	EuroQol-visual analogue scales (EQ-VAS) Survey	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
Primary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	14 weeks
Secondary	Percentage of subjects achieving SE = 85%		8 weeks
Secondary	Compliance (completion rate of lessons, for WELT-IP group only)	Compliance is evaluated as completion rate of lessons.	8 weeks