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A Preliminary Randomized Controlled Trial Examining the Effects of Rumination Focused Cognitive Behavioral Therapy on Autism Spectrum Disorder and their Brain Basis

A Preliminary Randomized Controlled Trial Examining the Effects of Rumination Focused Cognitive Behavioral Therapy on Autism Spectrum Disorder and their Brain Basis - A Preliminary Randomized Controlled Trial Examining the Effects of Rumination Focused Cognitive Behavioral Therapy on Autism Spectrum Disorder and their Brain Basis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040092
Enrollment
30
Registered
2020-04-15
Start date
2020-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Interventions

Rumination Focused Cognitive Behavioral Therapy (RFCBT) including every week 12 one-hour sessions and treatment as usual Treatment as usual

Sponsors

Hamamatsu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Changes in the Hamilton Depression Rating Scale (HDRS) 17-item version between baseline and endpoint.

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactShun Takeichi

Hamamatsu University School of Medicine Department of Psychiatry

41310482@hama-med.ac.jp053-435-2295

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026