UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054701 |
|---|---|
| Receipt number | R000062510 |
| Scientific Title | Cognitive Behavioral Therapy for Persistent Persistent Postural Perceptual Dizziness in Japan: a Pre Post Comparative Study |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2024/12/18 10:42:00 |
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Basic information
Public title
Cognitive Behavioral Therapy for Persistent Postural Perceptual Dizziness in Japan: a Pre Post Comparative Study
Acronym
Cognitive Behavioral Therapy for Persistent Postural Perceptual Dizziness in Japan
Scientific Title
Cognitive Behavioral Therapy for Persistent Persistent Postural Perceptual Dizziness in Japan: a Pre Post Comparative Study
Scientific Title:Acronym
Cognitive Behavioral Therapy for Persistent Postural Perceptual Dizziness in Japan
Region
| Japan |
Condition
Condition
Persistent Postural Perceptual Dizziness
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prevalence of dizziness in the general population is estimated to be 20-30%, and among people of working age, 74% have persistent dizziness for more than 6 months and 30% for more than 5 years, resulting in significant social losses due to chronic dizziness. However, treatment is inadequate, in part because much of the chronic vertigo is organically unexplained. The most common form of chronic vertigo is persistent perceptual postural vertigo (PPPD), which has been described as a vicious circle of interaction between psychiatric symptoms such as anxiety and neurophysiological processes, with neurotic tendencies thought to be the underlying cause. Recently, it has been suggested that cognitive behavioural therapy may be effective in the treatment of chronic vertigo, but there are few reports of such therapy in Japan. The aim of this study was to carry out cognitive-behavioural therapy for patients with PPPD, to test its effectiveness, and to develop a programme of cognitive-behavioural therapy for patients with PPPD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Dizziness Handicap Inventory(DHI)
(Assessments are made at three time points: pre-intervention assessment, post-intervention assessment and follow-up assessment three months after the end of the intervention, using a patient-reported questionnaire).
Key secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
The Niigata PPPD questionnaire (NPQ)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
CBT for PPPD combined with usual care: The CBT for PPPD used in this study is a structured and manualised six-session programme consisting of psychoeducation, goal setting, internal sensory exposure, body scan, behavioural experimentation, behavioural activation, cognitive restructuring and relapse prevention components. It has the following components. A special text and worksheets are provided. During the treatment period, treatment continues as usual; CBT for PPPD is essentially face-to-face.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants were Japanese patients with PPPD aged 20 or older, diagnosed by a physician at Niigata University Hospital Otorhinolaryngology Department after 2020. Consecutive patients who had not received serotonergic antidepressant therapy after PPPD diagnosis, had no dose increase of serotonergic antidepressants prescribed by other departments within the past 3 months prior to PPPD diagnosis, Consecutive patients who were willing to participate in the study, proficient in reading and writing Japanese, and capable of attending regular CBT sessions were included in the study.
Key exclusion criteria
Those who have difficulty in understanding the questions in the self-administered questionnaire.
Other cases deemed inappropriate by the doctor in charge.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Arata |
| Middle name | |
| Last name | Horii |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Otolaryngology, Head and Neck Surgery,
Zip code
951-8510
Address
1-757 Asahimachidori, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-227-2306
ahorii@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsunehiko |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata University
Division name
Faculty of Education Specialized courses educational psychology
Zip code
950-2181
Address
8050, Ikarashi2-no-cho, Nishi-ku, Niigata City 950-2181, Japan
TEL
025-262-5460
Homepage URL
tanakat@ed.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology (MEXT). Japan Society for the Promotion of Science (JSPS).
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-757 Asahimachidori, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-227-2625
ethics@adm.niigata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062510
