UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023652 |
|---|---|
| Receipt number | 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 14:32:58 |
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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
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
f_oshima@chiba-u.jp
Sponsor or person
Institute
Research Center for Child Mental Development, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027222
