UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040092 |
|---|---|
| Receipt number | 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 13:10:21 |
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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
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
41310482@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045699
