UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029930 |
|---|---|
| Receipt number | R000034188 |
| Scientific Title | Preliminary effectiveness study of the Japanese version of cognitive behavioral treatment for complicated grief (J-CGT) |
| Date of disclosure of the study information | 2017/11/11 |
| Last modified on | 2022/05/17 22:28:53 |
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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
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
satonaka@musashino-u.ac.jp
Sponsor or person
Institute
Cognitive Behavioral Therapy and Research Institute, Musashino University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034188
