NIPH Clinical Trials Search

Examining the Feasibility of CBT using a Smartphone Application for PPPD

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	Persistent postural-perceptual dizziness
Date of first enrollment	27/08/2024
Target sample size	70
Countries of recruitment
Study type	Observational
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.

Outcome(s)

Primary Outcome	DHI(Dizziness Handicap Inventory)
Secondary Outcome	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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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