UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037191 |
|---|---|
| Receipt number | R000042398 |
| Scientific Title | Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression: A Pilot study |
| Date of disclosure of the study information | 2019/06/27 |
| Last modified on | 2022/09/15 16:45:19 |
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Basic information
Public title
Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression: A Pilot study
Acronym
RFCBT-Pilot study
Scientific Title
Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression: A Pilot study
Scientific Title:Acronym
Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression: A Pilot study
Region
| Japan |
Condition
Condition
Treatment-resistant Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety, efficacy and feasibility of Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 16wk
2. Drop-out rate
Key secondary outcomes
1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 28 and 40wk
2. Beck Depression Inventory (BDI-II), Generalized Anxiety Disorder (GAD-7), Ruminative Responses Scale (RRS), Sheehan Disability Scale (SDISS), Cognitive-Behavioral Avoidance Scale (CBAS), Coping Inventory for Stressful Situations (CISS): 0,8,16,28,40 wks
3. Quick Inventory of Depressive Symptomatology (QIDS), Euro-Qol (EQ-5D), Session Rating Scale (SRS) at each session
4. Client satisfaction questionnaire (CSQ-8j): 0, 8,16 wks
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
| Behavior,custom |
Interventions/Control_1
Rumination Focused Cognitive-Behavioral 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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) having a diagnosis of DSM-IV Major Depressive Disorder confirmed with the SCID
2) have been treated with antidepressants or cognitive behavioral therapy for depression at least 8 weeks up to screening.
3) GRID-HAMD-17>=14
4) can attend session more than 8
5) 20 years old <= age <70 years old
6) can obtain written consent
Key exclusion criteria
1) No alcohol or substance use disorder in 12 months prior to the screening
2) No history or concurrent manic episode or psychotic disorders
3) No other primary DSM-IV Axis I Disorders at screening
4) No comorbid of antisocial personality disorder
5) No serious suicidal ideation at screening
6) No organic brain lesions or major cognitive deficits in a year prior to the screening
7) No severe or unstable medical co-morbidities at screening
8) No structured psychotherapy during the intervention.
9) Other relevant reason decided by the CBT principal investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Atsuo |
| Middle name | |
| Last name | Nakagawa, MD, PhD |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3235
anakagawa@keio.jp
Public contact
Name of contact person
| 1st name | Atsuo |
| Middle name | |
| Last name | Nakagawa, MD, PhD |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3235
Homepage URL
anakagawa@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.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
慶應義塾大学医学部・慶應義塾大学病院 (東京都)
Keio University School of Medicine, Department of Neuropsychiatry (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 27 | 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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 27 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042398
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