Tokyo, March 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060911) titled 'A Pilot Study of an EMDR-Based Positive Imagery Exercise for People with Psychological Difficulties Related to Childhood Adversity' on March 19.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Hyogo University of Teacher Education
Condition:
Condition - Disturbances in Self-Organization Related to Adverse Childhood Experiences
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the feasibility, acceptability, and safety of EMDR Resource Development and Installation (RDI) for individuals with Disturbances in Self-Organization (DSO) related to Adverse Childhood Experiences (ACEs).
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Resource Development and Installation (RDI) in Eye Movement Desensitization and Reprocessing (EMDR)
RDI is a stabilization technique in EMDR for complex PTSD, based on the protocol by Korn and Leeds (2002). The intervention consists of three weekly sessions, each lasting 60 minutes.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Aged 18 to 65 years at the time of informed consent
2) Native Japanese speakers
3) Experienced Adverse Childhood Experiences (ACEs) before the age of 18, as assessed using the ACE scale for the Japanese context (ACE-J)
4) Meet the Disturbances in Self-Organization (DSO) criteria for complex PTSD, as assessed using the Japanese version of the International Trauma Questionnaire (ITQ-J)
Key exclusion criteria - 1) Current substance abuse
2) Current alcohol-related problems
3) Diagnosis of schizophrenia
4) Diagnosis of bipolar disorder
5) Cognitive impairment that significantly interferes with daily functioning
6) Acute suicidality within the past year, requiring hospitalization or referral to an emergency department
7) Specific preparation or planning for suicide within the past year
8) Received EMDR therapy within the past 6 months
9) Currently receiving trauma-focused psychotherapy
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 26 Day
Date of IRB - 2026 Year 03 Month 11 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069694
Disclaimer: Curated by HT Syndication.
