臨床研究等提出・公開システム

Japanese

Date of registration	July. 14, 2026
Last modified on	July. 14, 2026
Trial ID	jRCT1032260311

Scientific Title	An Exploratory Interventional Study on the Effects of Acupuncture on Mental Health
Public Title	Evaluating the Effects of Acupuncture on Mental Health


Contact for Scientific Queries	Name	Yano Yuichiro
	Address	1-5-29 Yushima, Bunkyo-ku, Tokyo
	Telephone	+81-3-3813-3111
	E-mail	y.yano@juntendo.ac.jp
Contact for Public Queries	Name	Yano Yuichiro
	Affiliation	Juntendo University
	Address	1-5-29 Yushima, Bunkyo-ku, Tokyo
	Telephone	+81-3-3813-3111
	E-mail	y.yano@juntendo.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		July. 14, 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	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Aged 18 to 64 years at the time of obtaining informed consent. 2. Individuals who received a full explanation regarding participation in this study, demonstrated sufficient understanding, and provided written informed consent of their own free will.
	Exclusion Criteria	1 Individuals currently attending hospitals or receiving treatment for mental disorders. 2 Individuals currently undergoing acupuncture, moxibustion, or massage therapy (defined as having a history of visits within the past 1 month). 3 Pregnant women. 4 Individuals currently using anticoagulants. 5 Individuals with local infection or inflammation at the candidate acupuncture sites. 6 Students of participating institutions (due to their enrollment in practical training of acupuncture). 7 Individuals otherwise judged by the principal investigator to be inappropriate as study participants.
	Age Minimum	18age old exceed
	Age Maximum	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Depression
Intervention(s)		Acupuncture therapy will be administered once a week for 4 weeks (approximately 1 month), with each session lasting approximately 40 minutes per participant.
Health Condition(s) Keyword		Depression
Intervention(s) Keyword		Acupuncture
Health Condition(s) Code		Depression
Intervention(s) Code		Acupuncture
Primary Outcome(s)		PHQ-9: Patient Health Questionnaire-9
Secondary Outcome(s)		Resilience (14-item Resilience Scale: RS-14) Presenteeism Quality of sleep (Athens Insomnia Scale: AIS) Well-being (The World Health Organization-Five Well-Being Index: WHO-5) Physical discomfort: Visual Analog Scale (VAS) scores for shoulder stiffness and low back pain Blood pressure and heart rate on treatment days Daily heart rate (measured via the ANBAI app) Daily heart rate variability (measured via the ANBAI app) Completion rate of the intervention

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Juntendo University School of Medicine
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
Telephone	+81-3-3813-3111
E-Mail	hongo-rinri@juntendo.ac.jp
Approval Status	Approval
Date of approval	July. 14, 2026

Plan to share IPD	Yes

Countries of Recruitment（Except Japan）	none