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Efficacy of digital brief behavioral treatment for insomnia using a smartphone application, with or without adjunctive light therapy, in individuals with insomnia symptoms and late chronotypes: a three-arm randomized controlled trial

Efficacy of digital brief behavioral treatment for insomnia using a smartphone application, with or without adjunctive light therapy, in individuals with insomnia symptoms and late chronotypes: a three-arm randomized controlled trial - SKUSH-3way trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061344
Enrollment
90
Registered
2026-04-21
Start date
2026-03-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sleep disturbance

Interventions

1. Digital brief behavioral treatment for insomnia Intervention using the sleep improvement app Sleep Healthy. (i) Sleep schedule for phase advance After the second week, the sleep phase was adva

Sponsors

Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Individuals who fall under "definite evening type" or "moderate evening type," defined as having a Morningness-Eveningness Questionnaire (MEQ) score between 16 and 41 2. Individuals with an Insomnia Severity Index (ISI) score of 8 or higher 3. Individuals aged 18 years or older but younger than 40 years at the time of consent 4. Individuals who own a smartphone with a version and model compatible with the application 5. Individuals whose first language is Japanese

Exclusion criteria

Exclusion criteria: 1. Individuals whose difference between current average wake-up time and target wake-up time exceeds 5 hours 2. Individuals who may experience significant time zone changes during the study period such as overseas travel Rationale: improvement through intervention is not expected 3. Individuals engaged in shift work or night work 4. Individuals with the following comorbid conditions: A. Those with photosensitivity B. Those with severe past medical history C. Those currently receiving treatment for insomnia or other sleep disorders D. Those undergoing outpatient treatment in psychosomatic medicine or psychiatry E. Individuals whose response frequency to Question 9 of the Patient Health Questionnaire-9 (PHQ-9)"Better off dead or thoughts of hurting yourself in some way" is "more than half the days" in the past two weeks

Design outcomes

Primary

MeasureTime frame
Changes in the Insomnia Severity Index (ISI) in the digital brief behavioral treatment for insomnia using a smartphone application alone group during the four-week intervention

Secondary

MeasureTime frame
Changes in the Insomnia Severity Index (ISI) were assessed in the digital BBT-I conjunction with light therapy group at pretest, weeks 1-4, and posttest. For both the digital BBT-I alone group and the digital BBT-I conjunction with light therapy group, changes from baseline to posttest and from baseline to follow-up were examined in the following outcomes: sleep onset time, wake-up time, time in bed, total sleep time, sleep onset latency, wake after sleep onset, time to get out of bed, sleep efficiency, bedtime, rise time, mid-sleep time, degree of sleep insufficiency, Morningness-Eveningness Questionnaire (MEQ) score, RU-SATED score, Epworth Sleepiness Scale (ESS) score, Patient Health Questionnaire-9 (PHQ-9) score, composite measures of sleep health score, social jetlag, and knowledge of sleep.

Countries

Japan

Contacts

Public ContactSatoe Okabayashi

Kyoto university Agency for Health, Safety and Environment

skush.threeway@gmail.com075-753-2407

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026