UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005367 |
|---|---|
| Receipt number | R000006366 |
| Scientific Title | Omega-3 polyunsaturated fatty acids for secondary prevention of critical incident stress after Japan earthquake March 11 in disaster medical assistance team (DMAT) workers: a randomized controlled trial |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2012/08/27 17:52:16 |
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Basic information
Public title
Omega-3 polyunsaturated fatty acids for secondary prevention of critical incident stress after Japan earthquake March 11 in disaster medical assistance team (DMAT) workers: a randomized controlled trial
Acronym
Healing DMAT workers' distress by omega-3 polyunsaturated fatty acids in emergency (HOPE): a randomized controlled trial
Scientific Title
Omega-3 polyunsaturated fatty acids for secondary prevention of critical incident stress after Japan earthquake March 11 in disaster medical assistance team (DMAT) workers: a randomized controlled trial
Scientific Title:Acronym
Healing DMAT workers' distress by omega-3 polyunsaturated fatty acids in emergency (HOPE): a randomized controlled trial
Region
| Japan |
Condition
Condition
Critical Incident Stress
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of omega-3 fatty acids supplementation for PTSD and depressive symptoms by comparing the outcome of the groups of omega-3 fatty acids supplementation added to psycho-education and psycho-education alone in DMAT workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Impact of Event Scale revised (IES-R)[Time frame: 3 month]
Key secondary outcomes
-The Center for Epidemiologic Studies Depression Scale(CES-D)[Time frame: 3 month]
-Resilience Scale short version(RS-14) [Time frame: 3 month]
-Kessler K6(K6)[Time frame: 3 month]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Psychoeducation + Omega-3 Polyunsaturated Fatty Acids
Interventions/Control_2
Psychoeducation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japan DMAT workers assigned to the disaster area following the Japan earthquake March 11
-A native Japanese speaking ability
-Those who can understand scope and contents in the trial
Key exclusion criteria
Use of warfarin within 3 month at regular intervals
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Matsuoka |
Organization
National Disaster Medical Center
Division name
Clinical Research Institute, Department of Psychiatry
Zip code
Address
Midoricho 3256, Tachikawa, Tokyo 190-0014, Japan
TEL
042-526-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Matsuoka |
Organization
National Disaster Medical Center
Division name
Clinical Research Institute, Department of Psychiatry
Zip code
Address
Midoricho 3256, Tachikawa, Tokyo 190-0014, Japan
TEL
Homepage URL
Sponsor or person
Institute
National Disaster Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Toyama
Kamakura Women's University
Tohoku Fukushi University
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
国立病院機構災害医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.biomedcentral.com/1471-244X/11/132
Publication of results
Published
Result
URL related to results and publications
http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowFulltext&ArtikelNr=336811&Ausgabe=257282&ProduktNr=223864
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 | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 01 | Day |
Last modified on
| 2012 | 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=R000006366
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
