Tele-Cognitive behavior therapy for Night Owl

JRCT ID: jRCT1030230038

Registered date:17/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Circadian Rhythm Sleep-Wake Disorders
• Date of first enrollment: 01/05/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Sleep midpoint calculated from sleep indices obtained by the wearable device Fitbit

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable

Include 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

Exclude 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

Related Information

• Primary Sponsor: Oi Hitomi
• Source(s) of Monetary Support: Ministry of education,National Center of Neurology and Psychiatry