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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033075
Receipt No. 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 2018/12/19

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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
Email 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
Email misu-n@umin.ac.jp

Sponsor
Institute National Hospital Organization Hizen Psychiatric Center
Institute
Department

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
Email

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
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
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037715

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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