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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name