UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062283 |
|---|---|
| Receipt number | R000071159 |
| Scientific Title | Efficacy of Online Imagery Rescripting Drawing Therapy (IRDT) in Reducing Subjective Distress in Healthy Adults with Distressing Memories: A Wait-List Controlled Randomized Trial |
| Date of disclosure of the study information | 2026/07/20 |
| Last modified on | 2026/07/20 23:00:45 |
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Basic information
Public title
Efficacy of Online Imagery Rescripting Drawing Therapy (IRDT) in Reducing Subjective Distress in Healthy Adults with Distressing Memories: A Wait-List Controlled Randomized Trial
Acronym
Efficacy of Online Imagery Rescripting Drawing Therapy (IRDT) in Reducing Subjective Distress in Healthy Adults with Distressing Memories: A Wait-List Controlled Randomized Trial
Scientific Title
Efficacy of Online Imagery Rescripting Drawing Therapy (IRDT) in Reducing Subjective Distress in Healthy Adults with Distressing Memories: A Wait-List Controlled Randomized Trial
Scientific Title:Acronym
Efficacy of Online Imagery Rescripting Drawing Therapy (IRDT) in Reducing Subjective Distress in Healthy Adults with Distressing Memories: A Wait-List Controlled Randomized Trial
Region
| Japan |
Condition
Condition
Subjective distress from adverse memories (Healthy volunteers)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Change in subjective distress associated with the most distressing adverse memory, measured by Visual Analogue Scale (VAS, 0-100), from baseline to week 3 (post-intervention).
Key secondary outcomes
Changes from baseline to week 3 (post-intervention) and week 6 (follow-up) in the following scales: Impact of Event Scale-Revised (IES-R), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Emotion VAS (fear/panic, anger, shame, guilt, disgust), Self-Compassion Scale Short Form (SCS-SF), Brief Resilience Scale-Japanese version (BRS-J), WHO-Five Well-Being Index (WHO-5), General Self-Efficacy Scale (GSES), Rosenberg Self-Esteem Scale-Japanese version (RSES-J), Plymouth Sensory Imagery Questionnaire short form (Psi-Q), Trait VAS (vividness of imagery, difficulty in verbalizing imagery), and Five Facet Mindfulness Questionnaire verbalization subscale (FFMQ). Also, the presence and severity of adverse events during the intervention period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Department of Cognitive Behavioral Physiology
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-0856
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Uratani |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-0856
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2027
Homepage URL
25fd0231@student.gs.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine, Chiba
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-222-7171
inohana-rinri@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学（千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 20 | Day |
Last modified on
| 2026 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071159
