UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002565 |
|---|---|
| Receipt number | R000003133 |
| Scientific Title | Effectiveness and feasibility study of the cognitive behavioral therapy for complicated grief in Japanese clinical setting |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2017/04/11 09:59:09 |
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Basic information
Public title
Effectiveness and feasibility study of the cognitive behavioral therapy for complicated grief in Japanese clinical setting
Acronym
An open label pilot study of the cognitive behavioral therapy for complicated grief
Scientific Title
Effectiveness and feasibility study of the cognitive behavioral therapy for complicated grief in Japanese clinical setting
Scientific Title:Acronym
An open label pilot study of the cognitive behavioral therapy for complicated grief
Region
| Japan |
Condition
Condition
Complicated grief
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness and feasibility of cognitive behavioral therapy for complicated grief in Japanese clinical setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Inventory of Complicated Grief (ICG)
2. Response rate(responder status: score of 2 or lower on the CGI-I or ICG improvement of at least 2SDs above baseline mean)
Key secondary outcomes
1. Mini-International Neuropsychiatric Interview (M.I.N.I.)
2. Structured Clinical Interview for Complicated Grief (SCI-CG)
3. Prolonged Grief Disorder Scale (PG-13)
4. Grief Related Avoidance Questionnaire (GRAQ)
5. Beck Depression Inventory-2 (BDI-2)
6. State-Trait Anxiety Inventory (STAI)
7. Impact of Event Scale-Revised (IES-R)
8. Posttraumatic Cognition Inventory (PTCI)
9. Pittsburg Sleep Quality Index (PSQI)
10. Connor-Davidson Resilience Scale (CD-RISC)
11. MOS 36-Item Short-Form Health Survey (SF-36)
12. Social Support Questionnaire short form (SSQ-6)
13.Positive and Negative Affect Schedule Scale(PANAS)
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 Behavioral Therapy for Complicated Grief (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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Complicated grief as the most important clinical problem
2. More than 30 score of Inventory of Complicated Greif
3. 13 months and over after the death of loved one
4. Stable antidepressant 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 once a week
7. Native Japanese speaker
Key exclusion criteria
1. Comorbidity of psychotic disorders, bipolar disorder, alcohol/drug dependence or abuse and group A personality disorder
2. History of psychotic disorders and bipolar disorder
3. History of alcohol/drug dependence or abuse in past 3 months
4. History of suicidal attempt or severe self-injury in past 6 months
5. Those who have difficulty for intervention such as cognitive impairment and mental retardation
6. Other mental/ physical conditions that may interfere this intervention
7. Ongoing or scheduled court litigation related to bereavement
8. Concurrent psychotherapy without supportive counseling
9. Pregnant or lactating woman
10. Concurrent other clinical trails
11. Those who are judged by screening doctors as inadequate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satomi Nakajima |
Organization
Fukushima Medical University
Division name
Radiation Medical Science Center for the Fukushima Health Management Survey
Zip code
Address
1 Hikariga-oka, Fukushima City,Fukushima,Japan
TEL
024-547-1887
snakajim@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Nakajima |
Organization
Fukushima Medical University
Division name
Radiation Medical Science Center for the Fukushima Health Management Survey
Zip code
Address
1 Hikariga-oka, Fukushima City,Fukushima,Japan
TEL
024-547-1887
Homepage URL
http://www.j-cgt.jp/
snakajim@fmu.ac.jp
Sponsor or person
Institute
National Center for Cognitive Behavioral Therapy and research, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Musashino University
International University of Health and Welfare Graduate School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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）
武蔵野大学心理臨床センター（東京都）
国際医療福祉大学大学院青山心理相談室（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 30 | Day |
Last modified on
| 2017 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003133
