UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028698 |
|---|---|
| Receipt number | R000032347 |
| Scientific Title | A Pilot Randomised Controlled Trial of Compassionate Mind Training for Treatment Resistant Depression |
| Date of disclosure of the study information | 2017/08/17 |
| Last modified on | 2020/03/22 16:38:36 |
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Basic information
Public title
A Pilot Randomised Controlled Trial of Compassionate Mind Training for Treatment Resistant Depression
Acronym
A pilot RCT of CMT for TRD
Scientific Title
A Pilot Randomised Controlled Trial of Compassionate Mind Training for Treatment Resistant Depression
Scientific Title:Acronym
A pilot RCT of CMT for TRD
Region
| Japan |
Condition
Condition
Major Depressive Disorder, Dysthymic disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the feasibility and effectiveness of Compassionate Mind Training for Treatment Resistant Depression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measured at Pre and Post intervention (12 sessions, once a week).
-Beck Depression Inventory-Second Edition
Key secondary outcomes
Measured at Pre and Post intervention (12 sessions, once a week).
-GRID-Hamilton Depression Rating Scale
-Self-Compassion Scale short form
-Fears of Compassion Scale
-Compassion Engagement and Action Scale
Number of adverse event and dropout rate,
and Client Satisfaction Questionnaire 8 at post treatment period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Compassionate Mind Training (12 sessions)
Interventions/Control_2
Treatment as usual
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary diagnosis of major depressive disorder or dysthymia refractory to two SSRI treatment (Taking antidepressant treatment while remaining at least moderately ill (BDI-II >= 20).
Aged 18 to 60 years
Key exclusion criteria
psychosis, active suicidality, organic brain disorder, substance abuse or dependence, antisocial personality disorder, other severe mental / physical condition
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Otani |
Organization
Chiba University
Division name
Safety and Health Organization
Zip code
Address
1-3, 3 Yayoicho, Inage-ku, Chiba city
TEL
043-290-2214
otanit@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Asano |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1, inohana, Chuo-ku, Chiba
TEL
043-226-2975
Homepage URL
kenichi.asano1225@gmail.com
Sponsor or person
Institute
Chiba University
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
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
| 2017 | Year | 08 | Month | 17 | 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 | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 17 | 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
| 2017 | Year | 08 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032347
| 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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