Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061669) titled 'Evaluating the effects of compassion and mindfulness meditation on family caregivers of people with dementia (single-arm pilot study)' on June 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kwansei Gakuin University
Condition:
Condition - Family caregivers of patients with dementia
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 for adult family caregivers of people with dementia, specifically examining improvements in well-being (primary outcome: QoL), emotional regulation (primary outcomes: Four Immeasurables, self-compassion, and mindfulness), and reductions in psychological distress (secondary outcomes: caregiver burden and depression).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A 12-week loving-kindness meditation and mindfulness program (weekly 90-minute group sessions and daily homework)
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1). Adults aged 18 to 75 years at the time of informed consent
2). Native Japanese speaker
3). Have a family member (including in-laws and aunts and uncles) who has been diagnosed with dementia, and spend more time than anyone else in the family caring for that person
4). The care recipient has been assessed as requiring support or long-term care
5). The care recipient has a DASC-21 score of 31 or higher as measured by the DASC-21
6). Able to use the internet, participate continuously in the 12-week sessions, and complete homework
Key exclusion criteria - A) Experienced instruction in meditation from an expert
B) Suicidal ideation is present (assessed by clinical interview)
C) Symptoms of schizophrenia, bipolar disorder, or alcohol/drug dependence are present
D) Severe physical disorders or cognitive disorders
E) Receiving medication or other psychotherapy for a mental illness
F) The care recipient resides in a specialized facility, such as a special nursing home for the elderly (excluding day care services)
Target Size - 27
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 24 Day
Date of IRB - 2026 Year 04 Month 24 Day
Anticipated trial start date - 2026 Year 06 Month 01 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=R000070562
Disclaimer: Curated by HT Syndication.