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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035161
Receipt No. R000040073
Official scientific title of the study Development and feasibility study of group cognitive behavioral therapy for the bereaved with distress of grief
Date of disclosure of the study information 2018/12/06
Last modified on 2018/12/06

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Basic information
Official scientific title of the study Development and feasibility study of group cognitive behavioral therapy for the bereaved with distress of grief
Title of the study (Brief title) Feasibility study of group cognitive behavioral therapy for distress of grief
Region
Japan

Condition
Condition grief
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop and examine feasibility of group cognitive behavioral therapy for the bereaved with distress of grief
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Grief symptoms (Inventory of Complicated Grief, ICG) and QOL (WHO/QOL-26) at post program, 3 months after the program from the base line will be compared.
Key secondary outcomes Presence of psychiatric disorders(M.I.N.I.), extent of subjective depressive symptoms(BDI-2), grief symptoms(CGQ), grief related avoidance(GRAQ), typical belief about grief(TBQ) and subjective well-being(SWBS) and suicidal behaviors(M.I.N.I. and BDI-2) at post program and 3 months after the program from the baseline will be compared.

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
Behavior,custom Other
Interventions/Control_1 Group cognitive behavioral therapy for distress of grief, once a fortnight, total 6 sessions, and 2 hours/one session
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Experience of the death of important others
2.6 months and over after the death
3.Those who have distress associated with grief
4.Those who can get permission to participate in this program from their doctor or counselor
5.Native Japanese speaker
6.Those who can give a written informed consent
7.Those who can participate basically in all sessions
Key exclusion criteria 1.Those who meet a criterion for severe prolonged grief disorder which is diagnosed by more than 26 score of ICG
2.Those who have co-morbid severe psychiatric disorders, i.e. psychotic disorders, bipolar disorder, alcohol/drug dependence or abuse and group A personality disorder
3.Those who have moderate to severe depression and anxiety disorders
4.Those who have a history of suicidal attempt during past year
5.Those who have severe cognitive dysfunctions that disturb completion of this program
6.Those who have severe or unstable physical disorders
7.Those who is treated by any structured psychotherapy without supportive counseling
8.Those who are judged by this study investigators as inadequate
Target sample size 30

Research contact person
Name of lead principal investigator Satomi Nakajima
Organization Musashino University
Division name Department of Human Sciences
Address 3-3-3 Ariake, Koto-ku, Tokyo 135-8181, Japan
TEL 03-5530-7618
Email satonaka@musashino-u.ac.jp

Public contact
Name of contact person Satomi Nakajima
Organization Musashino University
Division name Department of Human Sciences
Address 3-3-3 Ariake, Koto-ku, Tokyo 135-8181, Japan
TEL 03-5530-7618
Homepage URL
Email satonaka@musashino-u.ac.jp

Sponsor
Institute Musashino University
Institute
Department

Funding Source
Organization Musashino University Creating Happiness Incubation, Musashino University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 築地本願寺(東京)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 06 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 06 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 06 Day
Last modified on
2018 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040073

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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