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Effects of a compassion based intervention for adults with adverse childhood experiences: A Randomized Controlled Trial

Effects of a compassion base intervention on PTSD and complex PTSD symptoms associated with adverse childhood experiences: A Randomized Controlled Trial - A RCT study of CBI for PTSD and CPTSD with ACEs

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058443
Enrollment
72
Registered
2025-07-15
Start date
2025-07-16
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

Post-traumatic stress disorder Complex post-traumatic stress disorder

Interventions

A 12-week loving-kindness meditation program(weekly one and half hour group session, everyday homework) A 12-week wait-list control(receiving the same 12-wwek LKM program after the waiting period)

Sponsors

Kwansei Gakuin University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 ]

Secondary

MeasureTime frame
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]

Countries

Japan

Contacts

Public ContactKohki Arimitsu

Kwansei Gakuin University Department of Psychological Sciences

caslstudies@gmail.com0798546048

Outcome results

None listed

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