UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044247
Receipt number R000047217
Scientific Title Randomized, waiting-list controlled trial on the feasibility and effectiveness of small-group online cognitive-behavioral therapy for anxiety of Parkinson's disease
Date of disclosure of the study information 2021/05/18
Last modified on 2021/11/25 14:07:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A comparative study on the effectiveness of small group online cognitive behavioral therapy for anxiety of Parkinson's disease

Acronym

Small Group Online Cognitive Behavioral Therapy for anxiety of Parkinson's disease

Scientific Title

Randomized, waiting-list controlled trial on the feasibility and effectiveness of small-group online cognitive-behavioral therapy for anxiety of Parkinson's disease

Scientific Title:Acronym

A randomized, waiting-list controlled trial on the effectiveness of small-group online cognitive behavioral therapy for anxiety of Parkinson's disease

Region

Japan


Condition

Condition

Parkinson's disease

Classification by specialty

Neurology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effectiveness of cognitive behavioral therapy for anxiety of Parkinson's disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

To compare the Hamilton Rating Scale for Anxiety (HAM-A) between the cognitive behavioral therapy intervention group and the intervention waiting group

Key secondary outcomes

Hamilton Rating Scale for depression (HAM-D)
Generalized Anxiety Disorder-7 (GAD-7)
Physical Health Questionaire-9 (PHQ-9)
Toronto Alexithymia Scale 20 (TAS-20)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

cognitive behavioral therapy

Interventions/Control_2

Cognitive behavioral therapy after waiting period

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1)At the time of obtaining consent, the age is 20 to 90 years old
2)Parkinson's disease: A clinically reliable PD or a clinically reliable PD in the 2015 Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's disease (PD).
3) GAD-7 with 5 or more anxiety symptoms
4) Those who have received a sufficient explanation before participating in this research, and have obtained a sufficient understanding and obtained the informed consent of the research subject.

Key exclusion criteria

1) MoCA-J score 20 points or less
2) Have severe mental illness
3) Online conversation is impossible
4)In addition, those who the research director judges to be inappropriate as a research target person

Target sample size

32


Research contact person

Name of lead principal investigator

1st name Nishikawa
Middle name
Last name Noriko

Organization

Juntendo University School of Medicine

Division name

Department of Neurology

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo, Tokyo, JAPAN

TEL

03-3813-3111

Email

n.nishikawa.ts@juntendo.ac.jp


Public contact

Name of contact person

1st name Nishikawa
Middle name
Last name Noriko

Organization

Juntendo University School of Medicine

Division name

Department of Neurology

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo, Tokyo, JAPAN

TEL

03-3813-3111

Homepage URL


Email

n.nishikawa.ts@juntendo.ac.jp


Sponsor or person

Institute

Department of Neurology, Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science(JSPS)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo Clinical Research and Trial Center

Address

2-1-1,Hongo,Bunkyo-ku,Tokyo 113-8431,Japan

Tel

03-5802-1584

Email

kenkyu5858@juntendo.ac.jp


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

順天堂大学医学部附属順天堂医院(東京都)


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 18 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

No longer recruiting

Date of protocol fixation

2020 Year 06 Month 22 Day

Date of IRB

2020 Year 07 Month 30 Day

Anticipated trial start date

2020 Year 08 Month 18 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 07 Month 31 Day

Date trial data considered complete

2022 Year 07 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 18 Day

Last modified on

2021 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047217


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name