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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046606
Receipt No. 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 2022/01/19

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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
Email 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
Email kondo-masaki@umin.ac.jp

Sponsor
Institute Nagoya City Unversity
Institute
Department

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
Email 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 Open public recruiting
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
2022 Year 01 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053164

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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