Clinical Trial: Efficacy of Online Imagery Rescripting Drawing Therapy (IRDT) in Reducing Subjective Distress in Healthy Adults with Distressing Memories: A Wait-List Controlled Randomized Trial (Japan)

Tokyo, July 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062283) titled 'Efficacy of Online Imagery Rescripting Drawing Therapy (IRDT) in Reducing Subjective Distress in Healthy Adults with Distressing Memories: A Wait-List Controlled Randomized Trial' on July 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Chiba University

Condition: Condition - Subjective distress from adverse memories (Healthy volunteers) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy of Imagery Rescripting Drawing Therapy (IRDT), a novel approach integrating drawing and digital tools into imagery rescripting, delivered in an online setting, in reducing subjective distress in healthy adults with distressing memories, compared to a wait-list control group through a randomized controlled trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Imagery Rescripting Drawing Therapy (IRDT). All participants will be provided with an iPad and a designated pen free of charge, and will receive "Imagery Rescripting Drawing Therapy (IRDT)" online via a web conferencing system. The intervention will be conducted once a week (60 minutes each) for a total of 3 sessions. Interventions/Control_2 - Waitlist control (WLC). A 6-week waiting period will be established, during which only regular assessments will be conducted. After the final assessment at week 6, IRDT equivalent to the intervention group will be provided to those who request it.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1.Aged between 18 and 65 years. 2.Not currently undergoing treatment for any mental or physical illness. 3.Having experienced an adverse event in the past, with a Visual Analogue Scale (VAS) subjective distress score (out of 100) of 30 or higher, and wishing for alleviation through online drawing therapy. 4.Having an internet environment (computer, tablet, or smartphone). 5.Capable of understanding the explanation in Japanese and providing free and voluntary consent via a web conferencing system. Key exclusion criteria - 1.History of diagnosis of any mental disorder, such as schizophrenia, bipolar disorder, depression, or alcohol dependence. 2.Currently taking medication (including herbal medicines and supplements) for mental health issues. 3.Having experiences strongly suspected of being PTSD or acute stress disorder. 4.Having suicidal ideation (score of 2 or higher on question 9 of the PHQ-9). 5.Judged by the principal investigator or co-investigators as inappropriate to safely conduct this study. Target Size - 24

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 01 Day Date of IRB - 2026 Year 06 Month 09 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2027 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071159

Disclaimer: Curated by HT Syndication.