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Tele-Cognitive behavior therapy for Night Owl

Tele-Cognitive behavior therapy for Night Owl: Pilot study - TeCNO study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030230038
Enrollment
12
Registered
2023-04-17
Start date
2023-05-01
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Circadian Rhythm Sleep-Wake Disorders

Interventions

Cognitive Behavioral Therapy for circadian Rhythm sleep-wake disorders involves video/booklet self-study and 4 sessions within the intervention period, each approximately 30 minutes of remote CBT-R in

Sponsors

Oi Hitomi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Meeting DSM-5 diagnosis criteria of circadian rhythm sleep-wake disorder sleep-phase regressive type 2. Unable to participate in social activities because they are unable to wake up at the desired time at least 3 days per week. 3. Twelve years of age or older 4. Able to wear a wristwatch wearable device during sleep

Exclusion criteria

Exclusion criteria: 1. Engaged in shift work with night shifts 2. Sleep-wake schedule is significantly affected by other sleep disorders or psychiatric disorders 3. Determined inappropriate by the doctor for other reasons

Design outcomes

Primary

MeasureTime frame
Sleep midpoint calculated from sleep indices obtained by the wearable device Fitbit

Secondary

MeasureTime frame
1. Occurrence of adverse events 2. Adverse effect checklist for CBT-R 3. Subjective sleep obtained by sleep diary 4. Objective sleep and activity level obtained by Fitbit 5. Sleep-wake schedule based on self-rating (Japanese version of the Biological Rhythms Interview of Assessment in Neuropsychiatry Self-Report: J-BRIAN-SR) 6. Self-rated depressive symptoms (Patient Health Questionnaire-9: PHQ-9) 7. Self-rated anxiety symptoms (Generalized Anxiety Disorder-7: GAD-7) 8. Self-rated Daytime function (EuroQol 5 dimentions: EQ-5D, Japanese version of Epworth Sleepiness Scale:JESS) 9. Cognitive function by PC program rating (Cognition) 10. Self-rated sleep-wake condition scale (Insomnia Severity Index: ISI, Morningness-Eveningness Questionnaire: MEQ, Japanese version of the Sleep Hygiene Practices Scale: SHPS-J) 11. Screen time 12. Attitudes about electronic-Therapy (electronic-Therapy Attitudes and Process questionnaire: eTAP, electronic-Therapy Attitudes and Process questionnaire-Therapist version: eTAP-T) 13. Treatment relationship ( Japanese version of the Working Alliance Inventory-Short Revised: J-WAI-SR) 14. Physiological indicators during remote CBT-R (eye gaze, facial expression, skin potentials, voice) 15. Interviews for implementation of remote CBT-R

Contacts

Public ContactHitomi Oi

University of human environments

hitomi.oi@ncnp.go.jp+81-89-926-7008

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026