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
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
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
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
