A Pilot Study of an EMDR-Based Positive Imagery Exercise for People with Psychological Difficulties Related to Childhood Adversity

EMDR Resource Development and Installation for Individuals with Disturbances in Self-Organization Related to Adverse Childhood Experiences: A Pilot Single-arm Trial - EMDR-RDI for Disturbances in Self-Organization: Pilot Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060911

Enrollment

Registered

2026-03-19

Start date

2026-03-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disturbances in Self-Organization Related to Adverse Childhood Experiences

Interventions

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 Leed

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To assess feasibility, the following indicators will be used: - Recruitment rate (number of participants enrolled / target sample size) - Dropout rate (number of dropouts / number of participants), including reasons for dropout - Protocol adherence rate - Average duration per session (minutes) Recruitment rate, dropout rate, and protocol adherence rate will be calculated and reported as proportions. Reasons for dropout will be categorized, with specific details provided if necessary. The average duration per session will be reported as mean and standard deviation.	—

Measure

Time frame

To assess feasibility, the following indicators will be used: - Recruitment rate (number of participants enrolled / target sample size) - Dropout rate (number of dropouts / number of participants), including reasons for dropout - Protocol adherence rate - Average duration per session (minutes) Recruitment rate, dropout rate, and protocol adherence rate will be calculated and reported as proportions. Reasons for dropout will be categorized, with specific details provided if necessary. The average duration per session will be reported as mean and standard deviation.

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Secondary

Measure	Time frame
1. Acceptability The following measures will be used to assess acceptability: - Client Satisfaction Questionnaire (CSQ-8-J, Japanese version): assessed once after completion of all intervention sessions - Open-ended questionnaire on seven concepts of acceptability: assessed once on a later day following the completion of all intervention sessions using Microsoft Forms The results of the CSQ-8-J will be reported using descriptive statistics, including the mean, standard deviation, median, and range. Responses to the open-ended questionnaire will be analyzed qualitatively using thematic analysis based on Braun & Clarke (2006). 2. Safety The following measures will be used to assess safety: - Brief questionnaires monitoring suicidal thoughts, self-harm behaviors, and symptom worsening: assessed at the beginning of each intervention session The trial will be discontinued for affected participants, and, if necessary, emergency measures will be taken to ensure their safety. The number of participants who discontinue and the reasons for discontinuation will be reported. 3. Exploratory symptom changes The following measures will be used to assess changes in symptoms: - International Trauma Questionnaire (ITQ-J, Japanese version) - Posttraumatic Diagnostic Scale for DSM-IV (PDS-IV-J, Japanese version) These measures will be assessed at baseline and 1 month after completion of the final intervention session. For statistical analyses, a paired t-test will be used when the assumption of normality is met, and the Wilcoxon signed-rank test will be used when the assumption is not met. The significance level will be set at 5%. In addition, effect sizes and the Reliable Change Index will be calculated and reported. Statistical analyses will be conducted using R version 4.5.2 (R Core Team, 2026). This analysis is not intended to evaluate efficacy, but rather to explore the magnitude and direction of symptom changes to inform the design of future studies.	—

Measure

Time frame

1. Acceptability The following measures will be used to assess acceptability: - Client Satisfaction Questionnaire (CSQ-8-J, Japanese version): assessed once after completion of all intervention sessions - Open-ended questionnaire on seven concepts of acceptability: assessed once on a later day following the completion of all intervention sessions using Microsoft Forms The results of the CSQ-8-J will be reported using descriptive statistics, including the mean, standard deviation, median, and range. Responses to the open-ended questionnaire will be analyzed qualitatively using thematic analysis based on Braun & Clarke (2006). 2. Safety The following measures will be used to assess safety: - Brief questionnaires monitoring suicidal thoughts, self-harm behaviors, and symptom worsening: assessed at the beginning of each intervention session The trial will be discontinued for affected participants, and, if necessary, emergency measures will be taken to ensure their safety. The number of participants who discontinue and the reasons for discontinuation will be reported. 3. Exploratory symptom changes The following measures will be used to assess changes in symptoms: - International Trauma Questionnaire (ITQ-J, Japanese version) - Posttraumatic Diagnostic Scale for DSM-IV (PDS-IV-J, Japanese version) These measures will be assessed at baseline and 1 month after completion of the final intervention session. For statistical analyses, a paired t-test will be used when the assumption of normality is met, and the Wilcoxon signed-rank test will be used when the assumption is not met. The significance level will be set at 5%. In addition, effect sizes and the Reliable Change Index will be calculated and reported. Statistical analyses will be conducted using R version 4.5.2 (R Core Team, 2026). This analysis is not intended to evaluate efficacy, but rather to explore the magnitude and direction of symptom changes to inform the design of future studies.

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Countries

Japan

Contacts

Public ContactShunsuke Sato

Hyogo University of Teacher Education Joint Graduate School (Ph.D. Program) in Science of School Education

d24202h@hyogo-u.ac.jp0795-44-2068

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026