UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043953 |
|---|---|
| Receipt number | R000050198 |
| Scientific Title | Follow-up on Long-Term Outcomes of Cognitive Behavioral Therapy UNCOVER Study |
| Date of disclosure of the study information | 2021/04/16 |
| Last modified on | 2024/04/18 20:34:51 |
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Basic information
Public title
Follow-up on Long-Term Outcomes of Cognitive Behavioral Therapy
UNCOVER Study
Acronym
UNCOVER Study
Scientific Title
Follow-up on Long-Term Outcomes of Cognitive Behavioral Therapy
UNCOVER Study
Scientific Title:Acronym
UNCOVER Study
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a follow-up evaluation of depressed patients who have been treated with psychotherapy, including cognitive-behavioral therapy, to investigate their current status and course of treatment, and to examine their long-term prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
-Depression symptoms:GRID-HAMD(GRIDHamilton Rating Scale for Depression),BDI-II(Beck Depression Inventory-II),QIDS(Quick Inventory of Depressive Symptomatology Self-Reported)
Key secondary outcomes
-Temperament Personality:T&P(Temperament and Personality Questionnaire)
-Non-functional cognition:DAS(Dysfunctional Attitude Scale),ATQR(Automatic Thoughts Questionnaire Revised)
-QOL:EQ5D-5L(European Quality of Life Questionnaire-5 Dimension)
-Disability:SDS (Sheehan Disability Scale)
-Work performance:HPQ short form(WHO Health and Work Performance Questionnaire (short form))
-Others:Questionnaire about psychotherapy,Information about the course of treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are still attending the research institute, whose primary diagnosis is confirmed as major depressive disorder in DSM-IV-TR/DSM-5, and who have received psychotherapy (including cognitive-behavioral therapy)at the research institute in the framework of general clinical practice or clinical research, and for whom at least one year has passed since the start of treatment.
2) Subjects who are at least 20 years old and under 70 years old at the time of obtaining consent.
3) Subjects who are judged by the attending physician to have sufficient comprehension to understand the evaluation to be conducted in this study.
4) Subjects who give full consent in the participation of the study.
Key exclusion criteria
1) Subjects who are judged by the attending physician to be extremely unstable.
2) Subjects who are judged by the attending physician to have unstable mental symptoms such as imminent risk of self-harm or other harm.
3) Subjects who are judged by the attending physician to be inappropriate for participation in this study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Katayama |
| Middle name | |
| Last name | Nariko, MD, PhD |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3235
narikoktym@z2.keio.jp
Public contact
Name of contact person
| 1st name | Katayama |
| Middle name | |
| Last name | Nariko, MD, PhD |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
narikoktym@z2.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
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
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）Keio University Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The evaluation questionnaire (total time: about 60 minutes) and the depression symptom assessment (GRID-HAMD) (total time: about 20 minutes) are administered in the outpatient clinic. However, the questionnaire can be completed at home and returned later. In this case, a letter-pack envelope will be given to the research collaborator along with the questionnaire, and the cost of mailing the questionnaire will be borne by the researcher. In addition, GRID-HAMD can be conducted at the next visit to the clinic, or via web conference system or telephone, as long as the evaluation period is acceptable.
Management information
Registered date
| 2021 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050198
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
