UMIN-CTR Clinical Trial

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