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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023652
Receipt No. R000027222
Scientific Title The effectiveness of combination of cognitive behavior therapy and schema therapy for obsessive compulsive disorders with high-functional autism spectrum disorders.
Date of disclosure of the study information 2016/08/20
Last modified on 2016/08/17

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Basic information
Public title The effectiveness of combination of cognitive behavior therapy and schema therapy for obsessive compulsive disorders with high-functional autism spectrum disorders.
Acronym The effectiveness of schema therapy for obsessive compulsive disorders with high-functional autism spectrum disorders
Scientific Title The effectiveness of combination of cognitive behavior therapy and schema therapy for obsessive compulsive disorders with high-functional autism spectrum disorders.
Scientific Title:Acronym The effectiveness of schema therapy for obsessive compulsive disorders with high-functional autism spectrum disorders
Region
Japan

Condition
Condition Autism spectrum disorders with obsessive compulsive disorders
Classification by specialty
Neurology Psychosomatic Internal Medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is an exploratory investigation of the Feasibility of the combination of cognitive behavior therapy and schema therapy for patients diagnosed with obsessive compulsive disorders and autism spectrum disorders.
Basic objectives2 Others
Basic objectives -Others the secound aim will reveal the defferences between ASD with OCD or without OCD.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Y-BOCS
Vineland-2

Key secondary outcomes OCI
YSQ
SMI
PHQ9
GAD7
EQ5D

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 35 times of the combination of Schema therapy and Cognitive behavior 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
39 years-old >=
Gender Male and Female
Key inclusion criteria Primary diagnosis in autism spectrum disorders
Secoundary diagnosis is obsessive compulsive disorders
Key exclusion criteria Individual with who have histories of substance abuse, active sucidality, severe mental and physical condition, intelligence quotient < 80.
Target sample size 15

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 f_oshima@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumiyo Oshia
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
Homepage URL
Email f_oshima@chiba-u.jp

Sponsor
Institute Research Center for Child Mental Development, Chiba University
Institute
Department

Funding Source
Organization Department of grants-in-aid for scientific research
Organization
Division
Category of Funding Organization Non profit foundation
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 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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
Date of protocol fixation
2016 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 20 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 08 Month 17 Day
Last modified on
2016 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027222

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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