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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016903
Receipt No. R000019619
Scientific Title Pilot Study of Cognitive Behavioral Therapy for Japanese Parkinson's Disease Patients.
Date of disclosure of the study information 2015/03/26
Last modified on 2016/04/11

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Basic information
Public title Pilot Study of Cognitive Behavioral Therapy for Japanese Parkinson's Disease Patients.
Acronym CBT among Japanese Parkinson's Disease Patients.
Scientific Title Pilot Study of Cognitive Behavioral Therapy for Japanese Parkinson's Disease Patients.
Scientific Title:Acronym CBT among Japanese Parkinson's Disease Patients.
Region
Japan

Condition
Condition Parkinson's disease patients with depression
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility and efficacy of cognitive behavioral therapy for Japanese parkinson's disease patients with depression.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes GRID-HAMD
Key secondary outcomes Beck Depression Inventory-II, Hospital Anxiety and Depression Scale, State and Trait Anxiety Inventory, The Overall Anxiety Severity and Impairment Scale, SF-36

Base
Study type

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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 6 session of 50 minutes individual administrated cognitive behavioral theory
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. GRID-HAMD score is more than eight
2. Primary diagnosis was parkinson's disease with UK parkinson's disease society brain bank clinical diagnostic criteria
3. Stable dosage of any medication for six months
Key exclusion criteria 1. Any alcohol or substance abuse in the past six months
2. Psychotic symptoms
3. Diagnosis of dementia
4. Unstable physical condition
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Horikoshi, Ph.D.
Organization National Center of Neurology and Psychiatry
Division name Cognitive Behavioral Therapy Center
Zip code
Address Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL 042-341-2712
Email mhorikoshi@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Issei Shinmei
Organization National Center of Neurology and Psychiatry
Division name Cognitive Behavioral Therapy Center
Zip code
Address Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL 042-341-2712
Homepage URL
Email mhorikoshi@ncnp.go.jp

Sponsor
Institute Cognitive Behavioral Therapy Center PDCBT Study Group
Institute
Department

Funding Source
Organization the Intramural Research Grant (24-5)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 03 Month 26 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
2013 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 08 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
2015 Year 03 Month 24 Day
Last modified on
2016 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019619

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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