Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058443) titled 'Effects of loving-kindness meditation for adults with adverse childhood experiences: A Randomized Controlled Trial' on July 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Kwansei Gakuin University

Condition: Condition - Post-traumatic stress disorder Complex post-traumatic stress disorder Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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)

Eligibility: Age-lower limit - 18 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 Size - 72

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066824

Disclaimer: Curated by HT Syndication.