UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042215
Receipt number 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 2023/08/07 23:25:27

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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

20 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

12


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 or person

Institute

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

Institute

Department

Personal name



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

2023 Year 08 Month 07 Day



Link to view the page

Value
https://center6.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