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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040092
Receipt No. R000045699
Scientific Title A Preliminary Randomized Controlled Trial Examining the Effects of Rumination Focused Cognitive Behavioral Therapy on Autism Spectrum Disorder and their Brain Basis
Date of disclosure of the study information 2020/04/15
Last modified on 2020/10/06

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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

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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