UMIN-CTR Clinical Trial

Basic information
Public title	Development and feasibility study of group cognitive behavioral therapy for the bereaved with distress of grief
Acronym	Feasibility study of group cognitive behavioral therapy for distress of grief
Scientific Title	Development and feasibility study of group cognitive behavioral therapy for the bereaved with distress of grief
Scientific Title:Acronym	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	1st name Satomi Middle name Last name Nakajima
Organization	Musashino University
Division name	Faculty of Human Sciences
Zip code	135-8181
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	1st name Satomi Middle name Last name Nakajima
Organization	Musashino University
Division name	Faculty of Human Sciences
Zip code	135-8181
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	Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Administration Department, Musashino University
Address	3-3-3 Ariake, Koto-ku, Tokyo 135-8181, Japan
Tel	03-5530-7350
Email	sankan@musashino-u.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	武蔵野大学認知行動療法研究所

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 06 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	2018 Year 11 Month 01 Day
Date of IRB	2018 Year 11 Month 01 Day
Anticipated trial start date	2018 Year 12 Month 06 Day
Last follow-up date	2023 Year 03 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	2018 Year 12 Month 06 Day
Last modified on	2021 Year 05 Month 14 Day

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