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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046216
Receipt No. 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 2021/12/08

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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 Beckian 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 sessions
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
Email 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
Email y.umegaki@cc.nara-wu.ac.jp

Sponsor
Institute Faculty of Human Life and Environment, Nara Women's University
Institute
Department

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 Kyo Mental Clinic
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
Email 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 きょうこころのクリニック(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 Open public recruiting
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
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2026 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 11 Month 29 Day
Last modified on
2021 Year 12 Month 08 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052720

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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