UMIN-CTR Clinical Trial

Basic information
Public title	A Preliminary Randomized Controlled Trial Examining the Effects of Rumination Focused Cognitive Behavioral Therapy on Autism Spectrum Disorder and their Brain Basis
Acronym	Rumination Focused Cognitive Behavioral Therapy for Autism Spectrum Disorder
Scientific Title	A Preliminary Randomized Controlled Trial Examining the Effects of Rumination Focused Cognitive Behavioral Therapy on Autism Spectrum Disorder and their Brain Basis
Scientific Title:Acronym	A Preliminary Randomized Controlled Trial Examining the Effects of Rumination Focused Cognitive Behavioral Therapy on Autism Spectrum Disorder and their Brain Basis
Region	Japan

Condition
Condition	Autism Spectrum Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The current preliminary randomized controlled trial aimed to test effect of rumination focused cognitive behavioral therapy (RFCBT) in adults with autism spectrum disorder (ASD) and comorbid depressive symptoms, and aimed to explore neural correlates of the comorbid depressive symptoms and the recovery from them in the participants with ASD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Changes in the Hamilton Depression Rating Scale (HDRS) 17-item version between baseline and endpoint.
Key secondary outcomes	1. Resting state functional Magnetic Resonance Image(rs-fMRI) 2. Magnetic Resonance Image structure imag:T1- and T2-weighted images 3. Proton magnetic resonance spectroscopy(1H-MRS) 4. Beck Depression Inventory(BDI) 5. Ruminative Responses Scale(RRS) 6. State-Trait Anxiety Inventory(STAI) 7. Autism Spectrum Quotient-Japan(AQ-J) 8. Repetitive Behavior Scale-Revised(RBS-R)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Rumination Focused Cognitive Behavioral Therapy (RFCBT) including every week 12 one-hour sessions and treatment as usual
Interventions/Control_2	Treatment as usual
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Those who are 18 years old or older and under 50 years old at the time of obtaining consent. 2) Diagnosis of autism spectrum disorder based on Diagnostic and Statistical Manual of Mental Disorders-V(DSM-5)with score exceeding the cut-off value of Autism Diagnostic Observation Schedule Second Edition(ADOS-2)or Autism Diagnostic Interview-Revised(ADI-R). 3) Full Intelligent quotient above 80. 4) Hamilton Depression Rating Scale:(HDRS)score as 8 or more. 5) Applicants who have been given sufficient explanations to participate in this study and who have given their full understanding and consent in writing by themselves or their sponsors.
Key exclusion criteria	1) Those who have a high urgency for treatment, such as an imminent suicide attempt. 2) Patients with intracranial occupational lesions or vascular lesions such as cerebral infarction. 3) Patients with neurological diseases such as epilepsy. 4) MRI contraindicated. 5) Pregnancy or possible pregnancy.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hidenori Middle name Last name Yamasue
Organization	Hamamatsu University School of Medicine
Division name	Department of Psychiatry
Zip code	431-3192
Address	1-20-1, Handayama, Higasi-ku, Hamamatsu city, Shizuoka, 431-3192, Japan.
TEL	053-435-2295
Email	yamasue@hama-med.ac.jp

Public contact
Name of contact person	1st name Shun Middle name Last name Takeichi
Organization	Hamamatsu University School of Medicine
Division name	Department of Psychiatry
Zip code	431-3192
Address	1-20-1, Handayama, Higasi-ku, Hamamatsu city, Shizuoka, 431-3192, Japan.
TEL	053-435-2295
Homepage URL
Email	41310482@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University school of medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel	053-435-2295
Email	rinri@hama-med.ac.jp

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	2020 Year 04 Month 15 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
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	Enrolling by invitation
Date of protocol fixation	2019 Year 12 Month 03 Day
Date of IRB	2020 Year 07 Month 15 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 07 Day
Last modified on	2020 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045699