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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044247
Receipt No. 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

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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
Institute Department of Neurology, Juntendo University School of Medicine
Institute
Department

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
URL(English) https://upload.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


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