UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033075 |
|---|---|
| Receipt number | R000037715 |
| Scientific Title | A pilot study of of group cognitive behavioral therapy for adult with Attention-Deficit / hyperactivity Disorder. |
| Date of disclosure of the study information | 2018/06/21 |
| Last modified on | 2020/12/17 09:18:51 |
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Basic information
Public title
A pilot study of of group cognitive behavioral therapy for adult with Attention-Deficit / hyperactivity Disorder.
Acronym
A pilot study of group CBT for adult with ADHD.
Scientific Title
A pilot study of of group cognitive behavioral therapy for adult with Attention-Deficit / hyperactivity Disorder.
Scientific Title:Acronym
A pilot study of group CBT for adult with ADHD.
Region
| Japan |
Condition
Condition
Attention-Deficit / hyperactivity Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of a 8-week manualized cognitive behavior therapy group designed to enhance time-management and organization in adults with AD/HD in comparison with that of before treatment whether the reduction of the ADHD symptom and improvement of functional disorder (just after that two months later) are superior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Conners-Self Report is : Long Version (CAARS-S) is going to be completed by the participant at post intervention, 2 months follow up.
The Conners-Observer Report: Long Version (CAARS-O) is going to be also completed by a family member or close friend of the participant at post intervention, 2 months follow up.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A 90-minute group session is carried out eight times once a week. A participant of the groups is up to eight people. Two staff having the qualification of a clinical psychologist or a social worker or the nurse moves a group. The intervention contents are time management and rearranging order. Homework is imposed on a participant every session.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants are required to be between the ages of 20 and 65 with a DSM-4 diagnosis of ADHD (based on the CAADID).
Key exclusion criteria
Exclusion criteria included: schizophrenia; bipolar disorder;dementia; active substance abuse or dependence
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misuzu Nakashima |
Organization
Narional Hospital Organization Hizen Psychiatric Center
Division name
Division of Clinical Research
Zip code
Address
160, Mitsu, Yoshinogari-cho, Kanzaki-gun, Saga
TEL
0952-52-3231
misu-n@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misuzu Nakashima |
Organization
Graduate School of Human-Environment Studies, Kyushu University.
Division name
Toshihide Kuroki laboratory
Zip code
Address
6-19-1, Hakozaki, Higashi-ku, Fukuoka-shi, Fukuoka
TEL
092-642-3137
Homepage URL
misu-n@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Hizen Psychiatric Center
Institute
Department
Personal name
Funding Source
Organization
The Mental Health Okamoto memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 06 | Month | 21 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 05 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 05 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 21 | Day |
Last modified on
| 2020 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037715
