UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032427 |
|---|---|
| Receipt number | R000036978 |
| Scientific Title | Pilot single arm test of schema therapy for patients with chronic depression |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2023/05/07 10:21:12 |
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Basic information
Public title
Pilot single arm test of schema therapy for patients with chronic depression
Acronym
Effect of schema therapy on patients with chronic depression: pilot single arm test
Scientific Title
Pilot single arm test of schema therapy for patients with chronic depression
Scientific Title:Acronym
Effect of schema therapy on patients with chronic depression: pilot single arm test
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
exploring the effect of schema therapy on patients with chronic depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BDI-II:Beck Depression Inventory 2nd edition
Key secondary outcomes
PHQ-9:Patient Health Questionnaire-9
HAM-D:Hamilton Rating Scale for Depression
YSQ:Young Schema Questionnaire
SMI:Schema Mode Inventory
ECR-RS:Experience of Close Relationship-Relationship Structure
WAI:orking Alliance Inventory-Short Form
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
| Maneuver |
Interventions/Control_1
Schema Therapy
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Persons who have Japanese ability to understand and receive schema therapy.
2) Those who satisfy the diagnosis of depression or persistent depressive disorder by primary diagnosis using DSM-5
3) Person undergoing drug therapy for 2 years or more
4) Beck Depression Inventory - 2 (BDI - 2) has 14 or more persons
5) Person who consent acquisition age is between 20 and 60
6) Person who obtains document consent by his / her free will after receiving sufficient explanation for the participation of this exam
7) Normal treatment (regular interview with a doctor is essential, whether or not drug therapy is present) is being conducted and those who are not scheduled to start or change additional medication therapy during the study period
8) Persons who can understand schema therapy and have mental and physical conditions that can be practiced on a sustained basis for at least 1 year
9) If it meets the criteria of 1, it will not be excluded even when merging anxiety disorder etc
Key exclusion criteria
1) People whose IQ is less than 80 by JRAT which is a simplified intelligence test
2) Those who are the primary diagnosis of symptomatic mood disorder due to serious mental disorder such as brain organic disorder (including dementia), psychotic disorder, hypothyroidism, etc. Also, even if the substance-related disorder is a co-morbidity disease, a person who is unable to continue hospitalization for that reason
3) Two or more items of BDI-II suicide idea. Or who had the danger of suicide within one month of acquiring consent
4) Bipolar I disorder
5) Mental retardation
6) Autism spectrum
7) neurocognitive disorders
8) Person who had psychiatric inpatient treatment within half a year of registration date
9) Persons who are anticipated to be discontinued in schema therapy because they repeat antisocial acts
10) Persons who are expected to be discontinued in schema therapy because they have significant progressive physical disorders
11) Other persons who are judged inappropriate for the examination responsible doctor or the test sharing therapist to safely carry out this test
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavio ral Physiology, Research Center f or Child Mental Development
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomokazu Murata |
Organization
Research Center for Child Mental Development Chiba University
Division name
Department of Cognitive Informa tion Technology
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba, Japan
TEL
043-226-2975
Homepage URL
murata@chiba-u.jp
Sponsor or person
Institute
Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Research Center for Child Mental Development, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
Address
Tel
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 | 05 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 23 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036978
| Research Plan | |
|---|---|
| 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 |
