UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057595 |
|---|---|
| Receipt number | R000064259 |
| Scientific Title | A non-randomized pilot study to assess the usefulness and feasibility of Cognitive Behavioral Therapy for focal dystonia with anxiety and depression |
| Date of disclosure of the study information | 2025/04/11 |
| Last modified on | 2025/04/11 18:28:04 |
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Basic information
Public title
A non-randomized pilot study to assess the usefulness and feasibility of Cognitive Behavioral Therapy for focal dystonia with anxiety and depression
Acronym
Cognitive Behavioral Therapy for focal dystonia
Scientific Title
A non-randomized pilot study to assess the usefulness and feasibility of Cognitive Behavioral Therapy for focal dystonia with anxiety and depression
Scientific Title:Acronym
Cognitive Behavioral Therapy for focal dystonia
Region
| Japan |
Condition
Condition
focal dystonia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will develop a cognitive behavioral therapy for dystonia patients that utilizes online guided self-help content. The aim is to supplement its limitations and continually improve its usefulness by adding remote therapist sessions and self-help content.
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse events: Adverse events refer to any untoward occurrence during treatment, regardless of whether it is causally related to the treatment. Data are collected by self-report from patients.
Dropout: This refers to a participant withdrawing from treatment or the study midway. The reasons for dropout are investigated by telephone interview.
Hospital Anxiety and Depression Scale: This is a self-report questionnaire to assess the level of anxiety and depression. This scale allows for scores from 0 to 21 for each subscale (anxiety and depression), for a total of 42 points. For each subscale (anxiety and depression), higher scores indicate a higher severity of the symptom. (0-7 points: normal range (no or mild symptoms), 8-10 points: moderate symptoms, 11 points or more: severe symptoms)
Key secondary outcomes
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
| Other |
Interventions/Control_1
Cognitive behavioral therapy
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects diagnosed with focal dystonia by a neurologist
2) Subjects aged 18 to 65 years at the time of obtaining consent
3) Subjects currently visiting our hospital
4) Subjects whose attending physician has determined that they need to reduce anxiety and depression, and whose Hospital Anxiety and Depression Scale score is 8 or higher
5) Subjects whose medication dosage has not changed for more than three months at the neurology dystonia clinic
6) Subjects who understand the explanation regarding participation in the study and are able to consent
Key exclusion criteria
1) Psychotic disorder present at the time of screening (as diagnosed by a doctor)
2) Cognitive impairment MoCA-J score of 20 or less
3) Persons diagnosed with intellectual disability by their doctor
4) Manic episode present at the time of screening (as diagnosed by a doctor)
5) Severe substance use disorder present at the time of screening (as diagnosed by a doctor)
6) Severe suicidal ideation (as diagnosed by a doctor)
7) Persons with other problems that would prevent cognitive behavioral therapy from being implemented
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center of Neurology and Psychiatry Hospital
Division name
Department of Neurology
Zip code
1878551
Address
4-1-1 Ogawa Higashi-machi, Kodaira-shi, Tokyo
TEL
0423412711
ymukai@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center of Neurology and Psychiatry Hospital
Division name
Department of Neurology
Zip code
1878551
Address
4-1-1 Ogawa Higashi-machi, Kodaira-shi, Tokyo
TEL
0423412711
Homepage URL
ymukai@ncnp.go.jp
Sponsor or person
Institute
National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board at National Center Hospital for Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
Tel
042-341-2711
rinri-jimu@ncnp.go.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
| 2025 | Year | 04 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 1995 | Year | 03 | Month | 18 | Day |
Date of IRB
| 1995 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064259
