UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029031 |
|---|---|
| Receipt number | R000033205 |
| Scientific Title | Randomized controlled trial of a comprehensive cognitive training program for stress-related symptoms |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2024/12/02 13:35:25 |
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Basic information
Public title
Randomized controlled trial of a comprehensive cognitive training program for stress-related symptoms
Acronym
Randomized controlled trial of a comprehensive cognitive training program for stress-related symptoms
Scientific Title
Randomized controlled trial of a comprehensive cognitive training program for stress-related symptoms
Scientific Title:Acronym
Randomized controlled trial of a comprehensive cognitive training program for stress-related symptoms
Region
| Japan |
Condition
Condition
High anxious/depressive adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and action mechanisms of a memory-targeted cognitive training program on stress-related traits and symptoms in highly anxious/depressive adults using psychological/behavioral assessment and neuroimaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anxiety and depressive personality traits
Key secondary outcomes
Stress-related symptoms including anxiety and depression, memory biases, and stress hormone cortisol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
cognitive bias modification program (8 sessions/month)
Interventions/Control_2
non-cognitive bias modification program (8 sessions/month)
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who score 1SD or more on a neurotic personality-related trait questionnaire.
Key exclusion criteria
The following participants are excluded:
(1) those who have current Axis-I psychiatric disorders or substance-abuse history as determined by a structured clinical interview, (2) major medical illnesses including neurological diseases, (3) metal embedded in the body or medical appliance attached to the body, (4) history of brain injury or trauma with loss of consciousness over 10 minutes or more, (5) regular use of cold medicine, (6) excessive intake of caffeine or tobacco, (7) regular intake of psychotropics, steroids, or opioids within the previous 30 days or during the study period, and (8) those who received psychotherapy or counselling within the previous 30 days or will receive either of them during the study period.
Target sample size
212
Research contact person
Name of lead principal investigator
| 1st name | Hirokuni |
| Middle name | |
| Last name | Tagaya |
Organization
Kitasato University
Division name
Department of Health Sciences
Zip code
252-0329
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-7909
tagaya@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Hakamata |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health
Zip code
187-8553
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo, Japan.
TEL
042-346-1986
Homepage URL
hakamatay@ncnp.go.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Kitasato University Hospital
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8273
rinrib@med.kitasato-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | 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
| 2017 | Year | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033205
