UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021150 |
|---|---|
| Receipt number | R000024398 |
| Scientific Title | Long-term effectiveness and predictors of cognitive behavioral therapy for chronic dizziness |
| Date of disclosure of the study information | 2016/02/23 |
| Last modified on | 2023/03/02 14:51:39 |
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Basic information
Public title
Long-term effectiveness and predictors of cognitive behavioral therapy for chronic dizziness
Acronym
Long-term effectiveness and predictors of cognitive behavioral therapy for chronic dizziness
Scientific Title
Long-term effectiveness and predictors of cognitive behavioral therapy for chronic dizziness
Scientific Title:Acronym
Long-term effectiveness and predictors of cognitive behavioral therapy for chronic dizziness
Region
| Japan |
Condition
Condition
chronic dizziness (persistent postural-perceptual dizziness)
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the feasibility, long-term effectiveness, and predictors of cognitive behavioral therapy for chronic dizziness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Handicap due to dizziness (Dizziness Handicap Inventory) at 6 months after the treatment
Key secondary outcomes
Frequency of dizziness-related symptoms (Vertigo Symptom Scale-short form)
Anxiety and depressive symptoms (Hospital Anxiety and Depression Scale)
Somatic symptom (Somatic Symptom Scale-8)
Health anxiety (Short Health Anxiety Inventory)
Recovery process (Recovery Assessment Scale)
Valued action (Valuing Questionnaire)
Cognitive fusion (Cognitive Fusion Questionnaire)
Quality of life (EQ-5D-5L)
Alexithymia (Tronto Alexithymia Scale-20)
Mindfulness (Mindfulness Attention Awareness Scale)
Psychological flexibility (Acceptance and Action Questionnaire 2)
Insomnia (Insomnia Severity Index)
Clinical global impression
Patient global impression
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group program composed of vestibular rehabilitation and acceptance and commitment therapy: six weekly 2-hour sessions
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Outpatients with the chief complaint of chronic non-spinning vertigo, dizziness, or unsteadiness over three months, who has been consulting a neuro-otologist.
2) Fulfilling the diagnostic criteria for persistent postural-perceptual dizziness, with one or more of three exacerbation factors.
3) Sixteen or more of the total score of Dizziness Handicap Inventory.
Key exclusion criteria
1) Vertigo or dizziness caused by central nervous or organic factors, assessed by a neuro-otologist.
2) Physical states disturbing cognitive behavioral therapy or vestibular rehabilitation.
3) need for hospitalization.
4) Obvious suicidal ideation or self-harm.
5) Previous history of schizophrenia or bipolar disorder.
6) Comorbid psychiatric disorders excluding anxiety disorders and somatic symptom and related disorders.
7) Receiving other structured psychotherapies (except supportive counseling).
8) Difficult of a routine visit.
9) During pregnancy or planning for pregnancy during the treatment period.
10) Other reasons inadequate for study participation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kondo |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive Behavioral Medicine
Zip code
467-8601
Address
Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
TEL
052-853-8271
kondo-masaki@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kondo |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive Behavioral Medicine
Zip code
467-8601
Address
Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
TEL
052-853-8271
Homepage URL
kondo-masaki@umin.ac.jp
Sponsor or person
Institute
Department of Psychiatry and Cognitive Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address
Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 23 | 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
53
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2024 | 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
| 2016 | Year | 02 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024398
