UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062805 |
|---|---|
| Receipt number | R000071900 |
| Scientific Title | Efficacy of group intervention for Cognitive Disengagement Syndrome |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/03 15:35:17 |
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Basic information
Public title
Efficacy of group intervention for Cognitive Disengagement Syndrome
Acronym
CDS group
Scientific Title
Efficacy of group intervention for Cognitive Disengagement Syndrome
Scientific Title:Acronym
CDS group
Region
| Japan |
Condition
Condition
cognitive disengagement syndrome
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cognitive Disengagement Syndrome is a newly conceptualized clinical syndrome characterized by daydreaming, mental confusion, and slowed behavior and speech, with a prevalence of approximately 5%. Although it resembles the predominantly inattentive presentation of ADHD, it is symptomatologically distinct: individuals with CDS tend to disengage easily from external stimuli and become absorbed in their internal world, which delays task processing and makes it difficult to keep pace with conversation--often leading others to misinterpret this as laziness or indifference. CDS also shows high comorbidity with depression and anxiety disorders, and tends to respond poorly to ADHD pharmacotherapy and existing psychosocial interventions. To date, most research has focused on demonstrating symptomatological differences from ADHD, while studies in other domains remain sporadic. Recently, under the view that CDS constitutes an "independent diagnostic entity," it was concluded that "further research is needed to inform intervention" (Becker et al., 2023). Accordingly, this study aims to optimize intervention by conducting a group for individuals with CDS. As a pilot group, this iteration will center on an existing psychosocial treatment program originally developed for ADHD. Given that CDS is closely related to ADHD, some degree of effectiveness is anticipated; however, aspects of insufficient efficacy are also expected to remain. Through post-group interviews and questionnaires, this study will clarify both the effective aspects and limitations of the existing approach, as well as the difficulties CDS presents in adult daily life, in order to inform the design of subsequent group interventions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
K-6, WFIRS, WRADDS, ASRS, DERS, DDFS, MWQ, Epworth Sleepiness Scale
Key secondary outcomes
interview
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The content of the group generally follows a six-month protocol (held once a month) designed for adults with ADHD. Specifically, it consists of components such as "psychoeducation," "organization skills," "money management," "cognitive behavioral therapy," "time management," and "peer discussion among participants."
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were adults aged 18 years or older who had previously been suspected of having CDS, and who were able to converse, read, and write in Japanese.
Key exclusion criteria
Exclusion criteria were set as follows: (1) having a psychiatric disorder such as moderate or greater depression, (2) having a diagnosis of epilepsy or intellectual/developmental disorder, and (3) not having obtained the attending physician's permission to participate in the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toshinobu |
| Middle name | |
| Last name | TakedaTakeda |
Organization
Ryukoku University
Division name
fuculty of psychology
Zip code
600-8268
Address
125-1 Daiku-cho 7jyou-dori Shimogyo Kyoto
TEL
07043314138
toshinobu_takeda@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Toshinobu |
| Middle name | |
| Last name | Takeda |
Organization
Ryukoku University
Division name
faculty of psychology
Zip code
167
Address
125-1 Daiku-cho Shimogyo Kyoto
TEL
075-343-3311
Homepage URL
a10001@mail.ryukoku.ac.jp
Sponsor or person
Institute
Ryukoku University
Institute
Department
Personal name
Funding Source
Organization
Ryukoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seiwa Hospital
Address
91 Benten-cho Shinjyuku Tokyo
Tel
03-5579-8691
c.inoue@ionp.or.jp
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
晴和病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 10 | 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
| 2026 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071900
