Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059731) titled 'Randomized controlled trial of a smartphone application for suicide prevention (MYPLAN Japanese version)' on Dec. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Sapporo Medical University Hospital
Condition:
Condition - Psychiatic disorders, with suicidal ideation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to conduct a randomized controlled trial using the Japanese version of the MYPLAN application among patients with suicidal ideation, and to evaluate its effectiveness for suicide prevention.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Standard psychiatric treatment with MYPLAN Japanese version smartphone application, used over 15 minutes per day from enrollment.
Interventions/Control_2 - Standard psychiatric treatment; MYPLAN app provided after 8 weeks.
Eligibility:
Age-lower limit - 16
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Sixteen years of age or older
2. Suicidal ideation (PHQ-9 Item 9 score of 1 or higher.)
3. Owns a smartphone and able to install the app
4. Understands Japanese
5. Provides written informed consent
Key exclusion criteria - 1. No smartphone / unable to install app
2. Cannot understand Japanese
3. Current psychotic symptoms
4. Cognitive impairment
5. Considered unsuitable by treating psychiatrist
6. Other investigator-determined reasons
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Date of IRB - 2025 Year 07 Month 10 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2026 Year 01 Month 22 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068310
Disclaimer: Curated by HT Syndication.
