臨床研究等提出・公開システム

Japanese

Date of registration	April. 24, 2026
Last modified on	April. 24, 2026
Trial ID	jRCT1030260084

Scientific Title	Targeting Stress Reactivity Through Brief Home-Based Yoga Therapy for Caregivers of Patients with Eating Disorders (YOGA-TO-ED)
Public Title	Home-based Yoga Therapy for Caregivers of Patients with Eating Disorders (YOGA-TO-ED)

Contact for Scientific Queries	Name	Inoue Tomoko
	Affiliation	Department of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry
	Address	4-1-1, Ogawa-Higashicho, Kodaira-shi, Tokyo
	Telephone	+81-42-346-1961
	E-mail	inoue-tm@ncnp.go.jp
Contact for Public Queries	Name	Inoue Tomoko
	Affiliation	Department of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry
	Address	4-1-1, Ogawa-Higashicho, Kodaira-shi, Tokyo
	Telephone	+81-8066418107
	E-mail	inoue-tm@ncnp.go.jp

Recruitment status	Pending

Anticipated date of first enrollment		July. 01, 2026
Target sample size		80
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Caregivers Primary caregivers of patients diagnosed with anorexia nervosa (AN), bulimia nervosa (BN), or avoidant/restrictive food intake disorder (ARFID) according to DSM-5 Caregivers of patients aged 12 to 22 years at the time of consent Living with the patient Aged between 20 and 70 years Able to understand the study procedures and complete the required assessments and home-based practice Patients Diagnosed with anorexia nervosa (AN), bulimia nervosa (BN), or avoidant/restrictive food intake disorder (ARFID) according to DSM-5 Aged between 12 and 22 years at the time of consent Currently receiving outpatient treatment Duration of illness of at least 3 months Able to understand the study procedures and complete the required assessments
	Exclusion Criteria	Caregivers History of or current neurological disorders or cardiac disease that may affect heart rate variability (HRV) Currently receiving treatment for psychiatric disorders or serious physical illness Current regular practice of yoga or mindfulness-based interventions Patients History of or current neurological disorders or cardiac disease that may affect heart rate variability (HRV) Currently receiving treatment for severe physical illness or having a physical condition that interferes with daily functioning Presence of comorbid psychiatric disorders that would interfere with study participation Current regular practice of yoga or mindfulness-based interventions
	Age Minimum	12age old over
	Age Maximum	22age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Eating disorders (anorexia nervosa, bulimia nervosa, and avoidant/restrictive food intake disorder)
Intervention(s)		Yoga therapy (home-based program) Participants will receive an 8-week home-based yoga therapy program consisting of: Weekly psychoeducational video sessions (~5 minutes) focusing on stress regulation and mindfulness-based perspectives Daily home practice (~5 minutes per day), including: Isometric exercises Breathing techniques Meditation Participants will be instructed to practice at least 5 days per week. Additional support includes: Daily self-report of practice via a messaging application Weekly follow-up (via phone, online meeting, or messaging) to monitor adherence and address concerns After the intervention period, participants will undergo an additional 8-week follow-up period without active intervention.
Health Condition(s) Keyword		Eating disorders, anorexia nervosa, bulimia nervosa, avoidant restrictive food intake disorder
Intervention(s) Keyword		Yoga therapy, home-based intervention, mindfulness, breathing techniques, meditation
Health Condition(s) Code		F50.0Anorexia nervosa, F50.2Bulimia nervosa F50.8, Other eating disorders
Intervention(s) Code		N/A
Primary Outcome(s)		Change in caregiver burden as measured by the Zarit Burden Interview (ZBI)
Secondary Outcome(s)		Caregivers Psychological distress General Health Questionnaire 28 GHQ 28 Expressed emotion Family Attitude Scale FAS Family Questionnaire FQ Eating disorder related caregiver perception Anorectic Behavior Observation Scale ABOS Caregiver guilt Caregiver Guilt Questionnaire CGQ Japanese version of the Difficulties in Emotion Regulation Scale DERS Mindfulness Five Facet Mindfulness Questionnaire FFMQ Autonomic function assessed by heart rate variability HRV Qualitative changes based on semi structured interviews Patients Eating disorder symptoms Eating Attitudes Test 26 EAT 26 ChEAT 26 Parent child relationship Parental Bonding Instrument PBI Psychological distress GHQ 28 Self esteem Rosenberg Self Esteem Scale RSES Autonomic function assessed by HRV Qualitative outcomes semi structured interviews perceived changes adherence acceptability burden

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Clinical Research Review Board, National Center of Neurology and Psychiatry
Address	4-1-1, Ogawa-Higashicho, Kodaira-shi, Tokyo, Tokyo
Telephone	+81-42-346-1961
E-Mail	ml_rinrijimu@ncnp.go.jp
Approval Status	Approval
Date of approval	Jan. 09, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none