UMIN-CTR Clinical Trial

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
Email	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
Email	imai.r.nagoya@gmail.com

Sponsor
Institute	Nagoya City University Psychiatry and Cognitive-Behavioral medicine
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026278