Effects of on-line stress management

JRCT ID: jRCT1030230667

Registered date:29/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy population without visiting psychiatric or psychosomatic clinics
• Date of first enrollment: 29/02/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): The stress management group will complete a psychological questionnaire and undergo a health check by a doctor 6 and 12 weeks after the start of the study. The waiting list group will complete a psychological questionnaire and health check by a doctor again six weeks after the start of the study (week 7) before proceeding with the six-week program. At the end of the program, 12 weeks after the start of the study, participants will complete a psychological questionnaire and undergo a health check by a doctor.

Outcome(s)

• Primary Outcome: Japanese version of WHO-Five well-being index
• Secondary Outcome: Medical Symptom Checklist, Self-rated Stress Checklist, Profile of Mood States Ver.2, Tokyo University Egogram, Tronto Alexithymia Scale 20 items, Somatosensory Amplification Scale

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: < 75age old

Include criteria

Target participants are healthy people aged 15 to under 75 who can conduct remote interviews via computer or smartphone, and those who are "pre-symptomatic" (feeling physically and mentally unwell, but are admitted to a medical institution such as a psychiatry or psychosomatic clinic). Select those who are in the stage of not having received medical treatment.
Regarding the definition of "non-byou", refer to previous research (Kitashima, Maeno, Nakao. Journal of Psychosomatic Medicine 25:81-95, 2021), and use the Japanese version of the "WHO-5 Mental Health Status Table". Selection will be made based on scores on the ``K6 Depression and Anxiety'' questionnaire and confirmation of medical institution visits by a specialist doctor. The program is aimed at people who are generally healthy and have not visited a medical institution due to mental health issues, but who are aware of some kind of physical or mental illness. For those who wish to participate using the clinical trial information on the website, we will provide an explanation to the subjects of this study based on the explanatory document online, and if they consent, they will be registered as research participants.

• Exclude criteria: *Currently undergoing treatment at a psychiatric or psychosomatic medicine clinic due to mental illness.

Related Information

• Primary Sponsor: Nakao Mutsuhiro