UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007331 |
|---|---|
| Receipt number | R000008641 |
| Scientific Title | Effectiveness and feasibility study of internet-based cognitive behavioral therapy for complicated grief in Japanese clinical setting |
| Date of disclosure of the study information | 2012/02/21 |
| Last modified on | 2016/08/27 16:44:50 |
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Basic information
Public title
Effectiveness and feasibility study of internet-based cognitive behavioral therapy for complicated grief in Japanese clinical setting
Acronym
An open label pilot study of internet-based cognitive behavioral therapy for complicated grief
Scientific Title
Effectiveness and feasibility study of internet-based cognitive behavioral therapy for complicated grief in Japanese clinical setting
Scientific Title:Acronym
An open label pilot study of internet-based 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 internet-based 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
Inventory of Complicated Grief(ICG)
Key secondary outcomes
1. Mini-International Neuropsychiatric Interview (M.I.N.I.)
2. Grief Related Avoidance Questionnaire (GRAQ)
3. Beck Depression Inventory-2 (BDI-2)
4. State-Trait Anxiety Inventory (STAI)
5. Impact of Event Scale Revised (IES-R)
6. Posttraumatic Cognition Inventory (PTCI)
7. Connor-Davidson Resilience Scale (CD-RISC)
8. MOS 36-Item Short-Form Health Survey (SF-36)
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
Internet-based Cognitive Behavioral Therapy for Complicated Grief (twice a week, 10 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 20 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 use PC and E-mail
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
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akemi Shirai |
Organization
International University of Health and Welfare Graduate School
Division name
Research Institute of Health and Welfare Sciences, clinical psychology
Zip code
Address
Aoyama-1chomme tower 4F,1-3-3, Minami Aoyama, Minato-ku, Tokyo, Japan
TEL
03-6864-0302
akeshira@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akemi Shirai |
Organization
International University of Health and Welfare Graduate School
Division name
Research Institute of Health and Welfare Sciences, clinical psychology
Zip code
Address
Aoyama-1chomme tower 4F,1-3-3, Minami Aoyama, Minato-ku, Tokyo, Japan
TEL
03-6406-8621
Homepage URL
http://www.j-itcg.jp/
akeshira@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Graduate School Research Institute of Health and
Welfare Sciences, clinical psychology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Musashino University
National Institute of Mental Health, National Center of Neurology and Psychiatry
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
| 2012 | Year | 02 | Month | 21 | 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
| 2011 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 20 | Day |
Last modified on
| 2016 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008641
