UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024758 |
|---|---|
| Receipt number | 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 01:33:26 |
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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
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
a-tsuchiyagaito@umin.ac.jp
Sponsor or person
Institute
Research Center for Child Mental Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028479
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
