UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048116 |
|---|---|
| Receipt number | 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 | 2023/12/21 12:01:30 |
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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
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
timemana@hotmail.com
Sponsor or person
Institute
National Hospital Organization Hizen Psychiatric Center, Division of clinical research
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
13
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
No longer recruiting
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
| 2025 | Year | 07 | 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
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054837
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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