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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024758
Receipt No. R000028479
Scientific Title Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder with Hoarding Symptoms
Date of disclosure of the study information 2016/11/08
Last modified on 2019/03/02

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Basic information
Public title Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder with Hoarding Symptoms
Acronym CBT for OCD with Hoarding
Scientific Title Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder with Hoarding Symptoms
Scientific Title:Acronym CBT for OCD with Hoarding
Region
Japan

Condition
Condition Obsessive-Compulsive Disorder
Hoarding Diorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of cognitive behavioral therapy for Obsessive-Compulsive Disorder (OCD) with hoarding symptoms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Saving Inventory- Revised (SI-R)
Key secondary outcomes Hoarding Rating Scale(HRS)
Structured Interview for Hoarding Disorder(SIHD)
Clutter Image Rating(CIR)
Saving Cognitions Inventory(SCI)
Obsessive Compulsive Inventory (OCI)
Dimensional Yale-Brown Obssessive-Compulsive Scale(DY-BOCS)
Yale-Brown Obssessive-Compulsive Scale(Y-BOCS)
Patient Health Questionnaire 9(PHQ-9)
Generalized Anxiety Disorder 7-item(GAD-7)
Sheehan Disability Scale(SDS)
Clinical Global Impression(CGI)
EuroQol 5 Dimension(EQ-5D)
Autism Spectrum Quotient(AQ)
Wechsler Adult Intelligence Scale-Third Edition (WAIS)

Base
Study type Interventional

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Cognitive Behavioral Therapy
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

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Primary diagnosis of obsessive-compulsive disorder or hoarding disorder
Key exclusion criteria Individuals who have histories of substance abuse, active sucidality, severe mental and physical condition, and intelligence quotient < 80.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko Nakagawa
Organization Chiba University
Division name Research Center for Child Mental Development
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2975
Email akikon@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aki Tsuchiyagaito
Organization Osaka University
Division name United Graduate School of Child Development
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2975
Homepage URL
Email a-tsuchiyagaito@umin.ac.jp

Sponsor
Institute Research Center for Child Mental Development
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 08 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
Two patients with hoarding disorder were enrolled in this study. We could not recruit expected number of subjects, and this study was closed.  
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
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2019 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028479

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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