UMIN-CTR Clinical Trial

Public title

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

Acronym

A Pilot Study of an EMDR-Based Positive Imagery Exercise

Scientific Title

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

Scientific Title:Acronym

EMDR-RDI for Disturbances in Self-Organization: Pilot Study

Region

Japan

Condition

Disturbances in Self-Organization Related to Adverse Childhood Experiences

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

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.

Key secondary outcomes

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

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.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

65

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 sample size

15

Name of lead principal investigator

1st name	Chihoko
Middle name
Last name	Unno

Organization

Hyogo University of Teacher Education

Division name

Graduate School of Education

Zip code

673-1494

Address

942-1 Shimokume, Kato-city, Hyogo, 673-1494, Japan

TEL

0795-44-2068

Email

cunnotom@hyogo-u.ac.jp

Name of contact person

1st name	Shunsuke
Middle name
Last name	Sato

Organization

Hyogo University of Teacher Education

Division name

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

Zip code

673-1494

Address

942-1 Shimokume, Kato-city, Hyogo, 673-1494, Japan

TEL

0795-44-2068

Homepage URL

Email

d24202h@hyogo-u.ac.jp

Institute

Hyogo University of Teacher Education

Institute

Department

Personal name

Chihoko Unno

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Counseling Room Seqoia
Arata Clinic of Psychosomatic Medicine

Name of secondary funder(s)

Organization

Research Ethics Committee of Hyogo University of Teacher Education

Address

942-1 Shimokume, Kato-city, Hyogo, 673-1494, Japan

Tel

N/A

Email

office-kenkyu-t@ml.hyogo-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

03

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

03

Month

12

Day

Last modified on

2026

Year

03

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069694