臨床研究等提出・公開システム

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

Tele-Cognitive behavior therapy for Night Owl (TeCNO study)

Oi Hitomi

University of human environments

9-12 Dogo-Himata, Matsuyama, Ehime 790-0825, Japan

h-oi@uhe.ac.jp

Oi Hitomi

University of human environments

9-12 Dogo-Himata, Matsuyama, Ehime 790-0825, Japan

+81-89-926-7008

hitomi.oi@ncnp.go.jp

Recruiting

May. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Circadian Rhythm Sleep-Wake Disorders

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 intervention (weeks 0-3). Session 1 consists of sharing a video clip on sleep-wake rhythms followed by an interview to establish target behaviors. Session 2 involves adjusting the sleep schedule and sharing video clip of daytime activities followed by adjusting the sleep schedule. Session 3 includes video sharing of daytime activities followed by adjustments to sleep schedule. In Session 4, video clip about maintenance and relapse prevention is shared, and interviews are conducted in addition to the review of the previous sessions. The study subjects and their parents or other family members may be present if they wish to participate in the session.

D020178

D015928

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

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

+81-42-341-2711

Jan. 13, 2023

Yes

If other research institutions or companies wish to make secondary use of the data from this clinical trials, they must obtain the approval of the principal investigator, prepare a new protocol, etc., and have it reviewed and approved by the Ethics Review Committee. For the secondary use of the data, written informed consent has been obtained from the subjects in this clinical trials.

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