UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046786 |
|---|---|
| Receipt number | R000053371 |
| Scientific Title | Verification of the effect of cognitive behavioral therapy randomized controlled trials for patients with chronic dizziness. |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/08/02 12:29:19 |
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Basic information
Public title
Verification of the effect of cognitive behavioral therapy randomized controlled trials for patients with chronic dizziness.
Acronym
Verification of the effect of RCT on CBT for patients with chronic dizziness.
Scientific Title
Verification of the effect of cognitive behavioral therapy randomized controlled trials for patients with chronic dizziness.
Scientific Title:Acronym
Verification of the effect of RCT on CBT for PPPD patients.
Region
| Japan |
Condition
Condition
PPPD Persistent Postural-Perceptual Dizziness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinical effectiveness of cognitive behavioral therapy interventions in addition to regular medical care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DHI Dizziness Handicap Inventory
Key secondary outcomes
NPQ Niigata PPPD Questionnaire
HADS Hospital Anxiety and Depression Scale
STAI State-Trait Anxiety Inventory
Cognitive Bias Scale
VSS-sf Vertigo Symptom Scale-short form
RSES Rosenberg Self Esteem Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive behavioral therapy
Interventions/Control_2
Usual Treatment
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Dizziness patients who are aware of balance disorders such as dizziness and floating feeling that last for 3 months or more, and the therapeutic effect is insufficient with conventional medical treatment etc.
Key exclusion criteria
Persons suspected of having dementia or cognitive decline.
Patients with or suspected of having severe depression, bipolar disorder, schizophrenia, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Tsunoda |
Organization
Mejiro University
Division name
Otologic Research Institute Clinic of Mejiro University
Zip code
339-8501
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama
TEL
048-797-3341
r.tsunoda@mejiro.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Tsunoda |
Organization
Mejiro University
Division name
Otologic Research Institute Clinic of Mejiro University
Zip code
339-8501
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama
TEL
048-797-3341
Homepage URL
r.tsunoda@mejiro.ac.jp
Sponsor or person
Institute
Otologic Research Institute Clinic of Mejiro University
Institute
Department
Personal name
Funding Source
Organization
Otologic Research Institute Clinic of Mejiro University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama
Tel
048-797-2115
univsyomu@mejiro.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
目白大学耳科学研究所クリニック(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | 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
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
Suspended
Date of protocol fixation
| 2021 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053371
