UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050790 |
|---|---|
| Receipt number | R000057875 |
| Scientific Title | Web-based interpersonal psychotherapy for bereavement-related major depressive disorder and prolonged grief disorder: the feasibility study |
| Date of disclosure of the study information | 2023/04/12 |
| Last modified on | 2024/03/18 00:22:38 |
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Basic information
Public title
Web-based interpersonal psychotherapy for bereavement-related major depressive disorder and prolonged grief disorder: the feasibility study
Acronym
Web-based interpersonal psychotherapy among the bereaved families: the feasibility study
Scientific Title
Web-based interpersonal psychotherapy for bereavement-related major depressive disorder and prolonged grief disorder: the feasibility study
Scientific Title:Acronym
Web-based interpersonal psychotherapy among the bereaved families: the feasibility study
Region
| Japan |
Condition
Condition
bereavement-related major depressive disorder/prolonged grief disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine feasibility of web-based interpersonal psychotherapy for bereavement-related major depression or prolonged grief disorder
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of subjects during the intervention
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Web-based interpersonal psychotherapy for bereavement-related major depressive disorder and prolonged grief disorder (once a week, 16 sessions)
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 bereavement with a significant other
2. Major depressive disorder or prolonged grief disorder is the most important clinical problem
(Depression onset between 6 months before and 12 months after the bereavement of a significant other)
3. For major depressive disorder, more than 10 scores on the Patient Health Questionnaire-9
For prolonged grief disorder, more than 26 scores on the Inventory of Complicated Grief
4. Patient visits his/her family psychiatrist at least once a month
5. The family psychiatrist determines the need for interpersonal psychotherapy(IPT) and allows the patient to receive IPT
6. The family psychiatrist is available to help with usual psychiatric crises
Key exclusion criteria
1. Comorbid psychiatric disorders, i.e. neurodevelopmental disorders, schizophrenia spectrum, other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, neurocognitive disorders, personality disorders, and substance use disorders
2. Active suicidal ideation
3. Need for hospitalization
4. Inexperienced operation of the web conferencing system that is deemed to interfere with the performance of treatment
5. Difficulty in operating the web conferencing system due to physical illness
6. Not an internet connection at home
7. Not a cell phone or other means of communication that can be used to promptly contact the patient in both directions in the event of any problems during treatment
8. Difficulty understanding this intervention, and communicating with the therapist in Japanese
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Toshishige |
Organization
Nagoya City University
Division name
Graduate School of Medical Sciences Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8271
yuu0323uchi@gmail.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Toshishige |
Organization
Nagoya City University
Division name
Graduate School of Medical Sciences Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8271
Homepage URL
yuu0323uchi@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Toshishige Yuko
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 Institutional Review Board
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-851-5511
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
| 2023 | Year | 04 | Month | 12 | 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
| 2023 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057875
