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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048116
Receipt No. R000054837
Scientific Title Preliminary effectiveness study of smartphone application as follow up after completion of time management program
Date of disclosure of the study information 2022/06/20
Last modified on 2022/06/20

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Basic information
Public title Five years follow-up of effect of cognitive behavior therapy for adults with ADHD
Acronym Five years follow-up of effect of cognitive behavior therapy for adults with ADHD
Scientific Title Preliminary effectiveness study of smartphone application as follow up after completion of time management program
Scientific Title:Acronym Five years follow-up of effect of cognitive behavior therapy for adults with ADHD
Region
Japan

Condition
Condition Attention-Deficit / hyperactivity Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to preliminarily examine the follow-up effectiveness of a time management program using a smartphone application.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes ADHD inattention/memory problem scores
Key secondary outcomes At the end of the intervention at 3 months
Time management scores, number of submissions to the app, number of days accomplished.

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 The free application "Minchare" will be used. This is a free application developed by AtenLabo, Inc. that has more than 1 million registered users as a "habit-forming application" for a group of five people. Five users who share the same goal post photos of their challenge achievements in a chat room, and points are awarded when they are approved by other users. In this study, ADHD patients who have difficulty with continuity were asked to post photos of things they had done, to do lists, and use of their schedule book. A reinforcement mechanism of cognitive-behavioral therapy is utilized, such as bonus points for achievement by all users in the team. A specialist is included in the team to routinely advise users on their time management efforts and to prevent problems.
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 Patients with diagnosed ADHD who completed the Time Management Group in December 2017. Meet the ADHD diagnostic criteria of the Diagnostic Interview for Adults with ADHD (DIVA), with ADHD symptom severity of at least 65 points in the clinical range on the CAARS Japanese version of A (inattention/memory).
Key exclusion criteria More than 1 month of psychiatric hospitalization. However, psychiatric hospitalization within 30 days of the application date, schizophrenia, bipolar disorder, dementia, and substance-related disorders are excluded.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Misuzu
Middle name
Last name Nakashima
Organization National Hospital Organization Hizen Psychiatric Center
Division name division of clinical research
Zip code 8420192
Address Mitsu 160, Yoshinogari-chou, Kanzaki-gun.
TEL 0952-52-3231
Email rin_rin22002@yahoo.co.jp

Public contact
Name of contact person
1st name Misuzu
Middle name
Last name Nakashima
Organization National Hospital Organization Hizen Psychiatric Center
Division name division of clinical research
Zip code 8420192
Address Mitsu 160, Yoshinogari-chou, Kanzaki-gun.
TEL 0952-52-3231
Homepage URL
Email timemana@hotmail.com

Sponsor
Institute National Hospital Organization Hizen Psychiatric Center, Division of clinical research
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Hizen Psychiatric Center, Division of clinical research
Address Mitsu 160, Yoshinogari-chou, Kanzaki-gun.
Tel 0952-52-3231
Email timemana@hotmail.com

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
2022 Year 06 Month 20 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 10 Day
Date of IRB
2022 Year 05 Month 26 Day
Anticipated trial start date
2022 Year 06 Month 21 Day
Last follow-up date
2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 20 Day
Last modified on
2022 Year 06 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054837

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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