Remote Cognitive Behavioral Therapy for Insomnia

JRCT ID: jRCT1030210575

Registered date:23/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Insomnia Disorder
• Date of first enrollment: 25/01/2022
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Cognitive Behavioral Therapy for Insomnia (CBT-I) includes 1) sleep hygiene, 2) stimulus control and sleep restriction, 3) titration, 4) daytime activities, and 5) review and relapse prevention. The intervention will be conducted online via the use of video conferencing software (Zoom) , with a total of 4 (+-2) sessions of 30 minutes each.

Outcome(s)

• Primary Outcome: Insomnia Severity Index: ISI

Secondary Outcome

1. Occurrence of adverse events
2. Adverse effect checklist for CBT-I
3. Objective sleep indices obtained from polysomnography
4. Subjective sleep indices obtained from sleep diary
5. Self-rated depressive symptoms (Patient Health Questionnaire-9: PHQ-9)
6. Self-rated anxiety symptoms (Generalized Anxiety Disorder-7: GAD-7)
7. Self-rated daytime functioning (Sheehan Disability Scale: SDISS, Epworth Sleepiness Scale: ESS)
8. Cognitive functioning (Cognition)
9. Self-rated insomnia pathology scale (Anxiety and Preoccupation about Sleep Questionnaire: APSQ, Dysfunctional Beliefs and Attitudes about Sleep scale-16: DBAS, Ford Insomnia Response to Stress Test: FIRST)
10. Attitudes about electronic-Therapy (electronic-Therapy Attitudes and Process questionnaire: eTAP, electronic-Therapy Attitudes and Process questionnaire-Therapist version: eTAP-T)
11. Working alliance (A Revised Short Version of Working Alliance Inventory: WAI)
12. Physiological indicators during remote CBT-I (eye gaze, facial expression, Galvanic Skin Response: GSR, voice)
13. Interviews for implementation of remote CBT-I
14. Free description on Remote CBT I
15. Treatment received after post-evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Meeting DSM-5 diagnosis criteria of chronic insomnia.
2. Has insomnia symptoms of at least mild severity or worse on the Insomnia Severity Index (ISI >= 8)
3. 18 years of age or older

Exclude criteria

1. engaged in shift work with night shifts
2. has other sleep disorders that are considered to have a significant impact on insomnia
3. has received or is currently receiving structured psychotherapy
4. determined inappropriate by the doctor for other reasons

Related Information

• Primary Sponsor: Nakajima Shun
• Source(s) of Monetary Support: Ministry of education,Cabinet Office