UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022841 |
|---|---|
| Receipt number | R000026278 |
| Scientific Title | Exploratory study to determine predictive factors of effectiveness of interpersonal psychotherapy for mood disorder,anxiety disorder,post-traumatic stress disorder and eating disorder |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2021/12/11 10:07:06 |
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Basic information
Public title
Exploratory study to determine predictive factors of effectiveness of interpersonal psychotherapy for mood disorder,anxiety disorder,post-traumatic stress disorder and eating disorder
Acronym
Exploratory study to determine predictive factors of IPT
Scientific Title
Exploratory study to determine predictive factors of effectiveness of interpersonal psychotherapy for mood disorder,anxiety disorder,post-traumatic stress disorder and eating disorder
Scientific Title:Acronym
Exploratory study to determine predictive factors of IPT
Region
| Japan |
Condition
Condition
mood disorder,anxiety disorder,post-traumatic stress disorder,eating disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate predictors of interpersonal psychotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mood disorder:Beck Depression Inventory-Second Edition(BDI-2)
panic disorder:The Self-report Version of the Panic Disorder Severity Scale(PDSS-SR)
social anxiety disorder:The Liebowitz Social Anxiety Scale Self Report(LSAS)
PTSD:PTSD Diagnostic Scale(PDS)
Eating disorder:Eating Disorder Inventory(EDI)
Key secondary outcomes
Social Adjustment Scale Self Report-SR(SAS-SR)
State and Trait Anger Scale/Anger Expression Scale(STAXI)
Interpersonal Sensitivity Measure(IPSM)
Self Compassion Scale(SCS)
IIP-64
Sheehan Disability Scale
EQ-5D-5L
Parental Bonding Instrument(PBI)
Childhood Trauma Questionnaire(CTQ)
Japanese Brief Grief Questionnaire
Ten Item Personality Inventory(TIPI)
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
| Other |
Interventions/Control_1
interpersonal psychotherapy, 16weekly 60-minute 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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The Diagnosis is Depressive Disorders" or "Bipolar and Related Disorders" or "Anxiety Disoredrs" or "Post-traumatic stress disorder" or "Feeding and Eating disorders"for DSM-5.
2. The patients is on the waiting list.
3. The patients who can be signed informed concent were enrolled in the present study.
Key exclusion criteria
1. The Diagnosis is "Schizophrenia Spectrum and Other Psychotic Disorders" or Obsessive-compulsive and Related Disorders" or "Cluster APersonality Disorders" or "Antisocial Personality Disorder" or "Neurodevelopmental Disorders" or "Neurocognitive disorders"
2. The patients who have active suicidal thought.
3. The patients who can't read and write questionnaire.
4. The patients who have any history of physical diseases or body condition that may prevent the study.
5. The patients who received or is going to receive other structured psychotherapy such as Cognitive-behavioral therapy.
6. Evidence of unable to participate half or more of the intervention phase.
7. The patients who their research doctor consider not suited.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kondo |
Organization
Nagoya City University
Division name
Psychiatry and Cognitive-Behavioral medicine
Zip code
Address
Kawasumi1, Mizuhocho, Mizuho-ku Nagoya-shi, Aichi, 467-0001, Japan
TEL
052-851-5511
kondo-masaki@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Risa Imai |
Organization
Nagoya City University
Division name
Psychiatry and Cognitive-Behavioral medicine
Zip code
Address
Kawasumi1, Mizuhocho, Mizuho-ku Nagoya-shi, Aichi, 467-0001, Japan
TEL
052-851-5511
Homepage URL
imai.r.nagoya@gmail.com
Sponsor or person
Institute
Nagoya City University
Psychiatry and Cognitive-Behavioral medicine
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
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
| 2016 | Year | 07 | 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
| 2016 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 22 | Day |
Last modified on
| 2021 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026278
