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 UMIN000026420
Receipt No. R000030352
Scientific Title Senzoku Intervention of Schema Therapy for Aid and Recovery from Chronic Depression (SISTAR*CD)
Date of disclosure of the study information 2017/03/25
Last modified on 2019/03/26

* 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 Senzoku Intervention of Schema Therapy for Aid and Recovery from Chronic Depression (SISTAR*CD)
Acronym Schema Therapy for Chronic Depression
Scientific Title Senzoku Intervention of Schema Therapy for Aid and Recovery from Chronic Depression (SISTAR*CD)
Scientific Title:Acronym Schema Therapy for Chronic Depression
Region
Japan

Condition
Condition Chronic depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Treatment response was defined as 50% or greater reduction in depressive symptoms (the 17-item GRID-Hamilton Depression Rating Scale; GRID-HAMD) at 104 weeks compared with baseline. The GRID-HAMD will be administered by clinical psychologists who will be blinded to treatment assignments. The 17- and 24-item GRID-HAMD will be assessed at baseline, 26 weeks, 52 weeks, 78 weeks, and 104 weeks.
Key secondary outcomes Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks.

Change in observer-rated depression severity was defined as the change score of the 17- and 24-item GRID-HAMD from baseline through 104 weeks.

Change in self-rated depression severity was defined as the change score of the Beck Depression Scale-II (BDI-II) from baseline through 104 weeks. The BDI-II will be assessed at baseline, 52 weeks, and 104 weeks.

Change in self-rated quality of life was defined as the change score of the EQ-5D-5L. The EQ-5D-5L will be assessed at baseline, 52 weeks, and 104 weeks.

Utility scores assessed by the EQ-5D-5L, depression severity assessed by the GRID-HAMD and BDI-II, and the utilization of medical services will be used for estimating cost-effectiveness and cost-utility.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Schema therapy in an individual format will be implemented by clinical psychologists. The treatment period will be 2 years with biweekly 50-minute sessions (up to 48 sessions).
Interventions/Control_2 Active monitoring by telephone will be implemented by clinical psychologists. The treatment period will be 2 years with monthly 10-minute sessions (up to 24 sessions).
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
40 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria -Persistent depressive disorder including chronic major depressive disorder and dysthymic disorder assessed by the Structured Clinical Interview for DSM
-Scores of at least 14 on the GRID-HAMD
-Psychiatric treatment duration for depression of at least 3 years
Key exclusion criteria -Psychiatric hospitalization within 30 days prior to the enrollment
-Ineligible to receive the protocol treatment during 2 years
-Schizophrenia
-Bipolar disorders
-Intellectual disabilities
-Neurocognitive disorders
-Substance-related disorders
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Emi
Middle name
Last name Ito
Organization Chiba University
Division name Research Center for Child Mental Development
Zip code 260-8677
Address 1-33, Yayoicho, Inage Ward, Chiba-shi, Chiba, 263-8522 Japan
TEL +81-043-251-1111
Email emiito@stress-coping.com

Public contact
Name of contact person
1st name Okumura
Middle name
Last name Yasuyuki
Organization Tokyo Metropolitan Institute of Medical Science
Division name Department of Psychiatry and Behavioral Science
Zip code 156-8506
Address 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo, 156-8506, Japan
TEL +81-3-6834-2296
Homepage URL
Email yokumura@blue.zero.jp

Sponsor
Institute 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 Japan

Other related organizations
Co-sponsor Senzoku stress coping support office
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research ethics committee of the graduate school of medicine, Chiba university
Address 1-8-1 Inohana, Chuo-ku Chiba, Japan
Tel 043-226-2841
Email igakurinri@office.chiba-u.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 洗足ストレスコーピング・サポートオフィス (東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 25 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
2017 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 21 Day
Last follow-up date
2025 Year 05 Month 01 Day
Date of closure to data entry
2025 Year 05 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 06 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030352

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.