UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032427
Receipt No. 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 2018/10/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email murata@chiba-u.jp

Sponsor
Institute Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Research Center for Child Mental Development, Chiba University
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 30 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036978

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.