UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of combination of cognitive behavior therapy and schema therapy for obsessive compulsive disorders with high-functional autism spectrum disorders.
Title of the study (Brief title)	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	Akiko Nakagawa
Organization	Chiba University
Division name	Research Center for Child Mental Development
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	Fumiyo Oshia
Organization	Chiba University
Division name	Research Center for Child Mental Development
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 08 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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