UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046606 |
|---|---|
| Receipt number | R000053164 |
| Scientific Title | Changes of resting-state brain function after acceptance and commitment therapy for persistent postural-perceptual dizziness |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2023/01/13 09:08:31 |
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Basic information
Public title
Changes of resting-state brain function after acceptance and commitment therapy for persistent postural-perceptual dizziness
Acronym
Changes of brain function after ACT for PPPD
Scientific Title
Changes of resting-state brain function after acceptance and commitment therapy for persistent postural-perceptual dizziness
Scientific Title:Acronym
Changes of brain function after ACT for PPPD
Region
| Japan |
Condition
Condition
persistent postural-perceptual dizziness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in resting-state brain function and brain structure before and after acceptance and commitment therapy for persistent postural-perceptual dizziness.
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between resting brain function/brain structure and clinical symptoms/process measures before and after Acceptance and Commitment Therapy for persistent postural-perceptual dizziness.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
MRI image
Handicap due to dizziness (Dizziness Handicap Inventory)
Frequency of vestibular symptoms (Vertigo Symptom Scale-short form)
Key secondary outcomes
Anxiety and Depressive symptoms (Hospital Anxiety and Depression Scale)
Insomnia (Insomnia Severity Index)
QOL (EuroQol-5 Dimensions-5 Level)
Burden by somatic symptoms (Somatic Symptom Scale-8)
Exacerbation factors of PPPD (Niigata PPPD Questionnaire)
Health anxiety (Short Health Anxiety Inventory)
Alexithymia (Tronto Alexithymia Scale-20)
Mindfulness (Mindfulness Attention Awareness Scale)
Interoceptive awareness (Multidimensional Assessment of Interoceptive Awareness)
Recovery process (Recovery Assessment Scale)
Psychological flexibility (Acceptance and Action Questionnaire-2)
Valued action (Valuing Questionnaire)
Cognitive fusion (Cognitive Fusion Questionnaire)
Patient's global Impression of Change
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
Acceptance and commitment therapy combined with vestibular rehabilitation (6 weekly group therapy sessions of 120 minutes each)
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) Visiting a neuro-otologist with a chief complaint of dizziness, unsteadiness, or non-spinning vertigo.
2) Meets the diagnostic criteria for persistent postural-perceptual dizziness.
3) Total score of 16 or more on the Dizziness Handicap Inventory.
4) From 20 years old to 64 years old.
5) Written consent.
Key exclusion criteria
1) Physical conditions that make it difficult to conduct psychotherapy or vestibular rehabilitation.
2) Psychiatric disorders other than DSM-5 anxiety disorders, somatic symptom disorder, or illness anxiety disorder diagnosed by a psychiatrist.
3) A history of DSM-5 schizophrenia or bipolar disorder diagnosed by a psychiatrist.
4) Suicidal ideation or self-injury determined by a psychiatrist.
5) SSRI or SNRI initiation or dose increase in the last month.
6) Receiving another cognitive behavioral therapy during the study period.
7) Receiving any otolaryngological treatment other than pharmacotherapy for vestibular diseases during the study period.
8) Difficulty in coming to our clinic during the study period.
9) Pregnant or planning to become pregnant.
10) Inadequate understanding of Japanese language.
11) Family members living with the researchers.
12) Contraindicated or unsuitable for MRI.
13) Abnormalities that are not suitable for analysis of MRI.
Target sample size
30
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
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
TEL
052-853-8271
Homepage URL
kondo-masaki@umin.ac.jp
Sponsor or person
Institute
Nagoya City Unversity
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
Tel
052-853-8348
irb_jimu@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
| 2022 | Year | 01 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 12 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053164
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