UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058443 |
|---|---|
| Receipt number | R000066824 |
| Scientific Title | Effects of loving-Kindness Meditation on PTSD and complex PTSD symptoms associated with adverse childhood experiences: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/12 16:57:55 |
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Basic information
Public title
Effects of loving-kindness meditation for adults with adverse childhood experiences: A Randomized Controlled Trial
Acronym
LKM for ACEs
Scientific Title
Effects of loving-Kindness Meditation on PTSD and complex PTSD symptoms associated with adverse childhood experiences: A Randomized Controlled Trial
Scientific Title:Acronym
A RCT study of LKM for PTSD and CPTSD with ACEs
Region
| Japan |
Condition
Condition
Post-traumatic stress disorder
Complex post-traumatic stress disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of an internet-based compassion and mindfulness meditation program on psychological distress (primary outcome measures: PTSD and CPTSD symptoms), emotional regulation (secondary outcome measures: resilience, self-compassion, etc.), and well-being (secondary outcome measures: life satisfaction, positive emotions, depression, anxiety, etc.) in adults with ACEs, compared to a waiting list control group (waiting group).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The total score of the ITQ [ Time Frame: pre, post, 3 month follow-up , and 6 month follow-up ]
The total score of ITI [ Time Frame: pre, post, 3 month follow-up , and 6 month follow-up ]
Key secondary outcomes
1) The severity ratings of PTSD symptoms by the Clinical Global Impressions Scale - Severity. [Time Frame: pre, post, 3 month follow-up , and 6 month follow-up]
2) Improvements of PTSD symptoms measured by the Clinical Global Impressions -Improvement. [Time Frame: pre, post, 3 month follow-up , and 6 month follow-up]
3) The total score of the PCL-5. [Time Frame: pre, post, 3 month follow-up , and 6 month follow-up]
4) Psychological indices: The Connor-Davidson Resilience Scale, Emotion Regulation Skills Questionnaire, Self-compassion Scale, Self-esteem scale, Watts Connectedness Scale, Nondual Awareness Dimensional Assessment, Five Facet Mindfulness Questionnaire, Satisfaction With Life Scale, Dispositional Positive Emotion Scale, and DASS 21. [Time Frame: pre, post, 3 month follow-up , and 6 month follow-up]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A 12-week loving-kindness meditation program(weekly one and half hour group session, everyday homework)
Interventions/Control_2
A 12-week wait-list control(receiving the same 12-wwek LKM program after the waiting period)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Adult between 18 and 75 years
2) Have one or more adverse childhood experience as measured by the ACE.
3) Have one or more self-organization disorders as measured by the ITI.
4) Have online interviews, surveys, and sessions in Japanese.
5) Provide informed consent for participation in 12 week sessions.
Key exclusion criteria
(a) Experienced intervention with meditation or yoga practices
(b) Severe substance use disorders, lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders (assessed by clinical interview)
(c)Actively considering plans of suicide or homicide (assessed by clinical interview)
(d)Severe physical disorders or cognitive disorders (dementia, severe traumatic Brain Injury)
(e) No permission from their physician or psychologist for any psychological problems
(f) Other relevant reason decided by the investigators
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Kohki |
| Middle name | |
| Last name | Arimitsu |
Organization
Kwansei Gakuin University
Division name
Department of Psychological Science
Zip code
663-8501
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo 662-8501, Japan
TEL
080-1361-9039
caslstudies@gmail.com
Public contact
Name of contact person
| 1st name | Kohki |
| Middle name | |
| Last name | Arimitsu |
Organization
Kwansei Gakuin University
Division name
Department of Psychological Sciences
Zip code
662-8501
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo 662-8501, Japan
TEL
0798546048
Homepage URL
https://clinical-affective-science.org/LKM.html
caslstudies@gmail.com
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Kohki Arimitsu
Funding Source
Organization
Grants-in-Aid for Scientific Research-KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University
Address
2-1, Gakuen, Sanda, Hyogo, Japan, 669-1337
Tel
079-565-9052
med-ethic@kwansei.ac.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
関西学院大学文学部総合心理科学科および心理科学実践センター(兵庫県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 15 | 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
| 2025 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 16 | 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
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066824
