UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046216 |
|---|---|
| Receipt number | R000052720 |
| Scientific Title | Effectiveness of a face-to-face rumination-focused cognitive-behavioral therapy for depression and anxiety |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2024/12/22 22:53:17 |
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Basic information
Public title
Evidence-Based Intervention for Rumination in Clinical Settings
Acronym
E-BIRCS
Scientific Title
Effectiveness of a face-to-face rumination-focused cognitive-behavioral therapy for depression and anxiety
Scientific Title:Acronym
RFCBT-NARA
Region
| Japan |
Condition
Condition
depression, anxiety
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Following Johnsen and Friborg's (2015) report that the effectiveness of cognitive-behavioral therapy (CBT) has been falling, ways to increase its effectiveness have been discussed. Although highly effective, CBT has limitations in dealing with depression/anxiety comorbidity and residual symptoms.
Rumination-focused CBT (RFCBT; Watkins, 2016) is a novel approach that (1) deals directly with comorbidity and residual symptoms, (2) has been shown to be effective for depression and anxiety from multiple RCTs, and (3) has developed from standard CBT. The aim of the present study is to adopt RFCBT in Japanese clinical settings to investigate its effectiveness for depression and anxiety, as well as points for adaptation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rumination: RRS
Depression: PHQ-9
Assessed at pre- and post-intervention and at each session
Key secondary outcomes
Worry: PSWQ
Anxiety: GAD-7
Assessed at pre- and post-intervention
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients receive 12 to 20 individual face-to-face RFCBT sessions (50m per session) weekly or once in several weeks.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 18 or over, with diagnosis of depression and/or anxiety (GAD), or showing risks or residual symptoms of either or both. Participation will follow doctor's consultation.
Key exclusion criteria
Age younger than 18; when the patient's doctor considers participation unsuitable, e.g., diagnosed with schizophrenia, manic episode etc.; those who requires intensive care e.g., showing risk to harm self or others
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Umegaki |
Organization
Nara Women's University
Division name
Faculty of Human Life and Environment
Zip code
630-8506
Address
Kita-Uoya-Nishi Machi, Nara City
TEL
0742203577
y.umegaki@cc.nara-wu.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Umegaki |
Organization
Nara Women's University
Division name
Faculty of Human Life and Environment
Zip code
630-8506
Address
Kita-Uoya-Nishi Machi, Nara City
TEL
0742203577
Homepage URL
y.umegaki@cc.nara-wu.ac.jp
Sponsor or person
Institute
Faculty of Human Life and Environment, Nara Women's University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Research with Human Subjects, Nara Women's University
Address
Kita-Uoya-Higashi Machi, Nara City
Tel
0742203762
kenkyou@cc.nara-wu.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
奈良女子大学臨床心理相談センター（奈良県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 30 | 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
Suspended
Date of protocol fixation
| 2021 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052720
