UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002565
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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/
Email snakajim@fmu.ac.jp

Sponsor
Institute National Center for Cognitive Behavioral Therapy and research, National Center of Neurology and Psychiatry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003133

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.