UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026420 |
|---|---|
| Receipt number | 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 | 2023/03/15 15:27:46 |
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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 21-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
emiito@stress-coping.com
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Okumura |
Organization
Initiative for Clinical Epidemiological Research
Division name
President
Zip code
194-0021
Address
1-2-5 Nakamachi, Machida, Tokyo
TEL
0428-16-2619
Homepage URL
yokumura@blue.zero.jp
Sponsor or person
Institute
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
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
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
| 2017 | Year | 01 | Month | 17 | Day |
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
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030352
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