UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026916 |
|---|---|
| Receipt number | R000030874 |
| Scientific Title | A randomized controlled trial of CBT therapy for adult with ADHD |
| Date of disclosure of the study information | 2017/04/09 |
| Last modified on | 2021/01/21 19:37:53 |
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Basic information
Public title
A randomized controlled trial of CBT therapy for adult with ADHD
Acronym
A randomized controlled trial of CBT therapy for adult with ADHD
Scientific Title
A randomized controlled trial of CBT therapy for adult with ADHD
Scientific Title:Acronym
A randomized controlled trial of CBT therapy for adult with ADHD
Region
| Japan |
Condition
Condition
ADHD
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 the person who is usually treated whether the reduction of the ADHD symptom of (just after that two months later six months later) and functional disorder improvement 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 and 6 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 and 6 months follow up.
Key secondary outcomes
CGI-S:at pre and post intervention, blind
fMRI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A 120-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
Usual treatment including the medical therapy
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 DIVA). Also required was a T-score of at least 66 (93 percentile) on the Inattentive/Memory subscale, DSM-4 Inattentive subscale or DSM-4 Total ADHD Symptom. It is also demanded that the participant continued psychiatry going to hospital treatment at the time of an application and passed more than one month.
Key exclusion criteria
Exclusion criteria included: schizophrenia; bipolar disorder;dementia; active substance abuse or dependence
Target sample size
48
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
3he17108e@s.kyushu-u.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
m.nakashima.733@s.kyushu-u.ac.jp
Sponsor or person
Institute
Narional Hospital Organization Hizen Psychiatric Center
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 09 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030874
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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