UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized Controlled Trial of Cognitive Behavioral Therapy for Japanese Parkinson's disease Patient with depression.
Title of the study (Brief title)	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	Maseru Horikoshi
Organization	National Center for Neurology and Psychiatry
Division name	Center for Cognitive behavioral therapy and research
Address	Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL	042-341-2711
Email	mhorikoshi@ncnp.go.jp

Public contact
Name of contact person	Issei Shinmei
Organization	National Center for Neurology and Psychiatry
Division name	Center for Cognitive behavioral therapy and research
Address	Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL	042-341-2711
Homepage URL
Email	issei@ncnp.go.jp

Sponsor
Institute	National Center for Neurology and Psychiatry
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025075