臨床研究等提出・公開システム

Japanese

Date of registration	April. 30, 2026
Last modified on	July. 13, 2026
Trial ID	jRCT1032260097

Scientific Title	Examining the Feasibility of Cognitive Behavioral Therapy Using Information and Communication Technology for Persistent Postural-Perceptual Dizziness: A Pilot Study
Public Title	Examining the Feasibility of CBT using a Smartphone Application for PPPD

Contact for Scientific Queries	Name	Horii Arata
	Affiliation	Niigata University Medical & Dental Hospital
	Address	Asahimachi-dori 1-754, Chuo-ku, Niigata City, Niigata
	Telephone	+81-25-227-6161
	E-mail	ahorii@med.niigata-u.ac.jp
Contact for Public Queries	Name	Horii Arata
	Affiliation	Niigata University Medical & Dental Hospital
	Address	Asahimachi-dori 1-754, Chuo-ku, Niigata City, Niigata
	Telephone	+81-25-227-2306
	E-mail	ahorii@med.niigata-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 30, 2026
Actual date of first enrollment		Aug. 27, 2024
Target sample size		70
Study Type		Observational
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Persistent postural-perceptual dizziness 2. Aged 18 years or older 3. Patients who own an Android or iOS device, can install the application independently, and can use it throughout the study period
	Exclusion Criteria	1. Prior CBTfor PPPD or dizziness 2. DHI score below 36 at screening 3. Unable to read or write in Japanese 4. Currently undergoing vestibular rehabilitation 5. Preference for in-person CBT for PPPD at the time of explanation 6. Psychiatric conditions deemed inappropriate for participation by the principal investigator or sub-investigators, including dementia, cognitive impairment, severe depression, severe anxiety, or poorly controlled schizophrenia or schizoaffective disorder 7. Serious physical illness making psychotherapy difficult, including severe respiratory, cardiovascular, neurological, or musculoskeletal disorders 8. Other patients who are judged to inappropriate as subjects
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Persistent postural-perceptual dizziness
Intervention(s)		The smartphone app group will use a digital therapeutic application designed for CBT targeting PPPD The sham group will use a digital therapeutic application with the same appearance and operability as the smartphone app group, but with therapeutic components removed.
Health Condition(s) Keyword		PPPD
Intervention(s) Keyword		Cognitive Behavioral Therapy
Health Condition(s) Code		D000099102
Intervention(s) Code		D015928
Primary Outcome(s)		DHI(Dizziness Handicap Inventory)
Secondary Outcome(s)		NPQ(Niigata PPPD Questionnaire) HADS(Hospital Anxiety and Depression Scale) EQ-5D-5L(EuroQol 5 dimensions 5-level) CGI-I(Clinical Global Impression-Improvement Scale) Adverse events Adherence

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics Committee of Niigata University
Address	1-754 Asahimachidori, Chuo-ku Niigata, Niigata, Niigata
Telephone	+81-25-227-2625
E-Mail	ethics@adm.niigata-u.ac.jp
Approval Status	Approval
Date of approval	July. 16, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	July. 13, 2026	(this page)	Changes
1	April. 30, 2026	Detail

List of change history