Tokyo, June 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061759) titled 'A prospective cohort study of long-term predictors of PTSD-related symptoms among new recruits of the Japan Maritime Self-Defense Force' on June 10.
Study Type:
Observational
Primary Sponsor:
Institute - National Defense Medical College
Condition:
Condition - PTSD-related symptoms and stress-related mental health outcomes
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - This long-term prospective cohort study will examine new recruits of the Japan Maritime Self-Defense Force. Baseline information on adverse childhood experiences, protective and compensatory experiences, psychological aptitude, self-compassion, and related factors will be integrated with annual mental health check-up and periodic health examination data. The study will explore the effects and interactions of early-life environmental factors, adult-life stress exposure, and genetic factors on the onset and longitudinal course of PTSD-related symptoms and related outcomes, including alcohol use, gambling behavior, and suicide-related events. In selected subsets of participants who consent to saliva collection, salivary DNA-derived genotype and DNA methylation data will also be used.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. New recruits of the Japan Maritime Self-Defense Force who enter training units or equivalent settings approved for the implementation of this study during the study period.
2. Individuals who understand the study explanation and provide written informed consent to participate in the study.
3. Individuals who are able to complete the baseline questionnaire and select either "questionnaire only" or "questionnaire plus saliva sample collection using Oragene" as their mode of participation.
4. Individuals aged 18 years or older at enrollment.
Key exclusion criteria - 1. Individuals who do not provide consent to participate in the study or who withdraw consent.
2. Individuals who are judged to have difficulty completing the baseline questionnaire. Individuals who have difficulty providing a saliva sample will be excluded from saliva collection and salivary DNA-based analyses but may participate in the "questionnaire only" arm.
3. Individuals for whom procedures necessary for assigning a study ID or linking annual data cannot be implemented.
Target Size - 8000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 30 Day
Date of IRB - 2026 Year 05 Month 25 Day
Anticipated trial start date - 2026 Year 07 Month 15 Day
Last follow-up date - 2046 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070669
Disclaimer: Curated by HT Syndication.