UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot Study of Cognitive Behavioral Therapy for Japanese Parkinson's Disease Patients.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masaru Horikoshi, Ph.D.
Organization	National Center of Neurology and Psychiatry
Division name	Cognitive Behavioral Therapy Center
Address	Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL	042-341-2712
Email	mhorikoshi@ncnp.go.jp

Public contact
Name of contact person	Issei Shinmei
Organization	National Center of Neurology and Psychiatry
Division name	Cognitive Behavioral Therapy Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000019619