UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary effectiveness study of the Japanese version of cognitive behavioral treatment for complicated grief (J-CGT)
Acronym	An open label pilot study of the Japanese version of cognitive behavioral treatment for complicated grief (J-CGT)
Scientific Title	Preliminary effectiveness study of the Japanese version of cognitive behavioral treatment for complicated grief (J-CGT)
Scientific Title:Acronym	An open label pilot study of the Japanese version of cognitive behavioral treatment for complicated grief (J-CGT)
Region	Japan

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

Objectives
Narrative objectives1	To examine effectiveness of the Japanese version of cognitive behavioral treatment for complicated grief
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of severity of complicated grief measured by ICG from the pre J-CGT to the 1-2 week after the end of treatment
Key secondary outcomes	Change of prevalence of complicated grief (ICG, CGQ), severity of grief related avoidance symptoms(GRAQ),typical belief related grief(TBQ), depression(BDI-2), anxiety(STAI),traumatic stress symptoms(IES-R),and posttraumatic cognitions(PTCI), QOL (EQ-5D-5L), satisfaction with life (SWLS), social support (SSQ) and the improvement of clinical global impression (CGI-I) from the pre J-CGT to the post J-CGT (1-2 weeks, 3 months and 6 months after the end of treatment)

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	Cognitive behavior therapy for complicated grief (fifty minutes / 1 session, 1 session/1-2 weeks, total 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.complicated grief as the most important clinical problem 2.more than 26 score of Inventory of Complicated Grief 3.13 months and over after the death of loved one 4.stable antidepressants, antipsychotics, and mood stabilizers medication for a minimum of 3 months, with at least 6 weeks at the same dose. 5.those who can give a written informed consent 6.those who can visit to hospital more than one time per two weeks 7.those who are under treatment at psychiatric or psychosomatic medicine department, and obtain approval from own doctor permission to participate in this intervention
Key exclusion criteria	1.comorbidity of schizophrenia or the other psychotic disorders 2.physical conditions that may interfere this intervention 3.presence of psychiatric symptoms below;manic episode of bipolar disorders, alcohol/drug dependence or abuse, severe depression, PTSD, self-injury, and suicidal attempt. 4.history of alcohol/drug dependence or abuse in past 6 months 5.history of suicidal attempt or severe self-injury in past 6 months 6.concurrent psychotherapy without supportive counseling 7.those who have difficulty for intervention such as cognitive impairment, impaired consciousness, and mental retardation 8.concurrent other clinical trails 9.those who have difficulty for understanding of this intervention, and communicating with clinician in Japanese 10.others whom the principal investigator decides to exclude
Target sample size	20

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	0355307618
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	350-8181
Address	3-3-3 Ariake, Koto-ku, Tokyo 135-8181, Japan
TEL	0355307618
Homepage URL	http://plaza.umin.ac.jp/~jcgt/index.html
Email	satonaka@musashino-u.ac.jp

Sponsor
Institute	Cognitive Behavioral Therapy and Research Institute, Musashino University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1.National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry 2.Cognitive Behavioral Therapy and Research Institute, Musashino University 3.International University of Health and Welfare 4. Hyogo Institute for Traumatic Stress
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	国立精神・神経医療研究センター病院（東京都) 武蔵野大学認知行動療法研究所（東京都) 国際医療福祉大学赤坂心理相談室（東京都） 兵庫県こころのケアセンター(兵庫県)

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 11 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	No longer recruiting
Date of protocol fixation	2017 Year 08 Month 08 Day
Date of IRB	2017 Year 09 Month 20 Day
Anticipated trial start date	2017 Year 11 Month 11 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	2017 Year 11 Month 11 Day
Last modified on	2022 Year 05 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034188