UMIN-CTR Clinical Trial

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
Email	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
Email	m.nakashima.733@s.kyushu-u.ac.jp

Sponsor
Institute	Narional Hospital Organization Hizen Psychiatric Center
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030874