UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056363 |
|---|---|
| Receipt number | R000064396 |
| Scientific Title | Developing web-based psychoeducation program for chronic pain with autistic and attention deficit hyperactivity traits: three arms randomized controlled trial |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2024/12/05 00:40:17 |
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Basic information
Public title
Developing a psychoeducation program for chronic pain with autistic and attention deficit hyperactivity traits
Acronym
psychoeducation program for chronic pain with neurodevelopmental disorder
Scientific Title
Developing web-based psychoeducation program for chronic pain with autistic and attention deficit hyperactivity traits: three arms randomized controlled trial
Scientific Title:Acronym
web-based psychoeducation program for chronic pain with autistic and attention deficit hyperactivity traits
Region
| Japan |
Condition
Condition
somatic symptoms disorder, Autism spectrum disorder, Attention deficit hyperactivity disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a psychoeducation program for chronic pain with autism spectrum disorder and attention deficit hyperactivity disorder, in addition to verifying the effectiveness and feasibility of the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain catastrophizing scale(PCS)
Key secondary outcomes
Japanese Brief Pain Inventory(BPI-J)
WHO-5
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
To watch ten short psychoeducation videos for chronic pain with NDD trait and to receive two online counseling.
Interventions/Control_2
To watch ten short psychoeducation videos for chronic pain with NDD trait.
Interventions/Control_3
To input the date and weather (sham control)
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Over 18 years of age at the time of consent
2) Meet diagnosis criteria of SSD, mainly pain
3) Meet diagnosis criteria of ASD and, or ADHD, or comorbidity NDD traits by over-cut-off of the questionnaire
4) To be able to accept a web-based program
Key exclusion criteria
1) Meet the diagnosis criteria of neurocognitive disorders, psychotic disorders, bipolar disorders, substance-related disorders, etc., severe psychiatric complications
2) Cancer pain
3) Having severe and proceeded somatic symptoms
4) Lawsuits and compensation about pain symptoms are involved
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Research centre for child mental development
Zip code
260-8670
Address
1-8-1 inohana cyuo-ku Chiba city
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University
Division name
Research centre for child mental development
Zip code
260-8670
Address
1-8-1 inohana chuo-ku Chiba city
TEL
043-226-2027
Homepage URL
k.taguchi@chiba-u.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba university clinical research center
Address
1-8-1 inohana chuo-ku Chiba city
Tel
043-222-7171
prc-jim@chiba-u.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
| 2024 | Year | 12 | Month | 05 | 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
42
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064396
