Verification of the effects of online counseling on improving sleep

JRCT ID: jRCT1010240070

Registered date:17/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sleep problems faced by workers
• Date of first enrollment: 17/02/2025
• Target sample size: 30
• Study type: Interventional

Intervention(s)

In the online counseling session, an initial counceling will be conducted.
1. Participants identified as having significant issues with sleep hygiene or other concerns will receive a consultation that includes sleep hygiene guidance.
2. Participants deemed likely to have chronic insomnia will receive online counseling based on Cognitive Behavioral Therapy for Insomnia (CBT-I).
The effectiveness of the interventions will be evaluated by comparing pre- and post-intervention outcomes for the combined intervention group (1 and 2). Additionally, the effectiveness of each intervention (1 and 2) will be assessed separately by comparing pre- and post-intervention results.

Outcome(s)

• Primary Outcome: Objective sleep variables derived from EEG measurements

Secondary Outcome

- Subjective sleep assessment items based on the initial survey and the Insomnia Severity Index (ISI).
- Survey items to assess the impact on work productivity and safety.
- Adverse events that occurred during the study (Adverse events are defined as any unfavorable or unintended symptoms newly appearing in the participants. However, those with a clearly negated causal relationship with the study protocol will not be considered adverse events).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both
• Include criteria: Among the up to 100 workers who understand the purpose and content of this study and voluntarily consent to participate, those who are classified into Group C (requiring sleep improvement) based on sleep EEG measurements and subjective sleep evaluations, and who wish to receive psychological intervention, will be included. The target number of cases is set at 30, but the actual number may vary depending on the classification into Group C and the number of participants who opt for psychological intervention.

Exclude criteria

- Those who are classified into Group A (good sleep), Group B (no major problems, but sleep and lifestyle habits require attention), or Group D (recommended to see a specialist as there is a risk of sleep disorders) based on the results of a sleep test
- Those who have been diagnosed with sleep disorders such as insomnia or sleep apnea syndrome, and are taking sleep-inducing drugs or insomnia medications (including over-the-counter drugs as well as prescription drugs), or are receiving treatment using CPAP or mouthpieces, etc.
- Those who work late at night or work shifts
- Others who are judged by the principal investigator and doctor to be unsuitable for participating in this study

Related Information

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