UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010065 |
|---|---|
| Receipt number | R000011786 |
| Scientific Title | Randomized controlled trial of eye movement desensitization and reprocessing (EMDR) and interpersonal psychotherapy (IPT) for non-suicidal self injury in adolescent and young adult female |
| Date of disclosure of the study information | 2013/02/18 |
| Last modified on | 2013/02/18 21:33:38 |
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Basic information
Public title
Randomized controlled trial of eye movement desensitization and reprocessing (EMDR) and interpersonal psychotherapy (IPT) for non-suicidal self injury in adolescent and young adult female
Acronym
JNSSIAP study
Scientific Title
Randomized controlled trial of eye movement desensitization and reprocessing (EMDR) and interpersonal psychotherapy (IPT) for non-suicidal self injury in adolescent and young adult female
Scientific Title:Acronym
JNSSIAP study
Region
| Japan |
Condition
Condition
Non-Suicidal Self Injury (NSSI)
Non-Suicidal Self Injury Not Otherwise Specified (NSSINOS)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate EMDR and IPT for Japanese adolescent and young adult female with NSSI and NSSINOS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinician-Administered PTSD Scale for DSM-IV (CAPS-SX)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
EMDR
Interventions/Control_2
IPT
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
| 12 | years-old | <= |
Age-upper limit
| 21 | years-old | >= |
Gender
Female
Key inclusion criteria
To be included in the study the participants (a) have to be between 12 and 18 years of age, (b) have non-suicidal self injury or non-suicidal self injury not otherwise specified.
Key exclusion criteria
Not fulfill criteria for psychotic disorder, schizotypal personality disorder, bipolar I disorder, autistic disorder, mental retardation or epilepsy. Two or more benzodiazepines prescribed or actively suicidal patients are excluded.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Ozaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
65 Tsurumaicho, Showaku, Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Futoshi Suzuki |
Organization
Nagoya University Hospital
Division name
Dept. of Child and Adolescnet Psychiatry
Zip code
Address
65 Tsurumaicho, Showaku, Nagoya
TEL
052-741-2111
Homepage URL
fsuzuki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 18 | Day |
Last modified on
| 2013 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011786
