UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021747 |
|---|---|
| Receipt number | R000025075 |
| Scientific Title | A Randomized Controlled Trial of Cognitive Behavioral Therapy for Japanese Parkinson's disease Patient with depression. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2018/04/11 17:36:27 |
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Basic information
Public title
A Randomized Controlled Trial of Cognitive Behavioral Therapy for Japanese Parkinson's disease Patient with depression.
Acronym
A RCT of CBT for Japanese Parkinson's disease patients.
Scientific Title
A Randomized Controlled Trial of Cognitive Behavioral Therapy for Japanese Parkinson's disease Patient with depression.
Scientific Title:Acronym
A RCT of CBT for Japanese Parkinson's disease patients.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to evaluate efficacy of cognitive behavioral therapy for Parkinson's disease patients with depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GRID-Hamilton Rating Scale for Depression (pre-treatment, 4 week, 8 week)
Key secondary outcomes
Hospital Anxiety and Depression Scale (pre-treatment, 1-8 week), MDS-Unified Parkinson's Disease Rating Scale (pre-treatment, 8 week), Visual Analogue Scale (8 week), Clinical Global Impression (1-8 week), EQ5D-QOL (pre-treatment, 1-8 week)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
8 sessions of cognitive behavioral therapy
Interventions/Control_2
Treatment as usual
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) outpatient receiving regular treatment in neurology at the NCNP
(2) primary diagnosis of Parkinson's disease
(3) GRID-HAMD score is 13 or more
(4) HDS-R is 20 or more
(5) Stable dosage of anti Parkinson medication over the past 3 month
Key exclusion criteria
(1) Any alcohol or substance abuse in the past six months
(2) Psychotic symptoms
(3 )Diagnosis of dementia
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maseru Horikoshi |
Organization
National Center for Neurology and Psychiatry
Division name
Center for Cognitive behavioral therapy and research
Zip code
Address
Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL
042-341-2711
mhorikoshi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Issei Shinmei |
Organization
National Center for Neurology and Psychiatry
Division name
Center for Cognitive behavioral therapy and research
Zip code
Address
Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL
042-341-2711
Homepage URL
issei@ncnp.go.jp
Sponsor or person
Institute
National Center for Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center for Neurology and Psychiatry
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
Address
Tel
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
国立精神・神経医療研究センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 01 | Day |
Last modified on
| 2018 | 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=R000025075
