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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042215
Receipt No. R000048151
Scientific Title Preliminary effectiveness of interpersonal psychotherapy for bereavement-related major depression and complicated grief among the bereaved families: a prospective observational study
Date of disclosure of the study information 2020/11/01
Last modified on 2021/03/27

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Basic information
Public title Preliminary effectiveness of interpersonal psychotherapy for bereavement-related major depression and complicated grief among the bereaved families: a prospective observational study
Acronym Preliminary effectiveness of interpersonal psychotherapy for bereavement-related major depression and complicated grief among the bereaved families: a prospective observational study
Scientific Title Preliminary effectiveness of interpersonal psychotherapy for bereavement-related major depression and complicated grief among the bereaved families: a prospective observational study
Scientific Title:Acronym Preliminary effectiveness of interpersonal psychotherapy for bereavement-related major depression and complicated grief among the bereaved families: a prospective observational study
Region
Japan

Condition
Condition major depressive disorder and persistent complex bereavement disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness of interpersonal psychotherapy for bereavement-related major depression and complicated grief among the Japanese bereaved families.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of severity of major depressive disorder measured by Patient Health Questionnaire(PHQ)-9 and persistent complex bereavement disorder measured by Inventory of Complicated Grief(ICG) from pretreatment to immediately posttreatment
Key secondary outcomes Change of EuroQol-5 Dimensions-5 Level(EQ-5D-5L), Cognitive Emotion Regulation Questionnaire(CERQ), Continuing Bonds Scale(CBS), Avoidance of the Loss Subscale of Grief-related Avoidance Questionnaire (GRAQ) and the Experience in Close Relationship-Relationship Structure(ECR-RS) from pretreatment to posttreatment(immediately, 3 months and 6 months after the end of treatment)

The Self-report Version of the Panic Disorder Severity Scale(PDSS-SR), The Liebowitz Social Anxiety Scale Self Report(LSAS), Posttraumatic Diagnostic Scale(PDS), Eating Disorder Inventory-2(EDI-2), or Generalized Anxiety Disorder-7(GAD-7) is performed only when a comorbid diagnosis of panic disorder, social anxiety disorder, posttraumatic stress disorder, eating disorder, or generalized anxiety disorder is made, respectively.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
25 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Experience of the death of important others.
2.Those who meet DSM-5 criteria for major depressive disorder or persistent complex bereavement disorder.
3.Need for IPT treatment.
4.Those who are under treatment at psychiatric or palliative care center.
5.Those who can give a written informed consent.
Key exclusion criteria 1.Need for hospitalization.
2.Comorbid psychiatric disorders, i.e. neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, neurocognitive disorders, and personality disorders.
3.Active suicidal ideation.
4.Experience of IPT treatment.
5.Receiving other structured psychotherapies (except supportive counseling).
6.Difficult of a routine visit.
7.Difficulty for understanding of this intervention, and communicating with clinician in Japanese.
8.Other reasons inadequate for study participation.

Target sample size 25

Research contact person
Name of lead principal investigator
1st name Yuko
Middle name
Last name Toshishige
Organization Nagoya City University Graduate School of Medical Sciences
Division name Psychiatry and Cognitive-Behavioral Medicine
Zip code 467-8601
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
TEL 052-851-5511
Email yuu0323uchi@gmail.com

Public contact
Name of contact person
1st name Yuko
Middle name
Last name Toshishige
Organization Nagoya City University Graduate School of Medical Sciences
Division name Psychiatry and Cognitive-Behavioral Medicine
Zip code 467-8601
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
TEL 052-851-5511
Homepage URL
Email yuu0323uchi@gmail.com

Sponsor
Institute Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science, and Technology
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 Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
Tel 0528587215
Email clinical_research@med.nagoya-cu.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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 01 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 Enrolling by invitation
Date of protocol fixation
2020 Year 09 Month 28 Day
Date of IRB
2020 Year 10 Month 12 Day
Anticipated trial start date
2020 Year 11 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

Other
Other related information Preliminary effectiveness of interpersonal psychotherapy for bereavement-related major depression and complicated grief among the bereaved families

Management information
Registered date
2020 Year 10 Month 22 Day
Last modified on
2021 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048151

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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