UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of psychotherapy for HIV patients infected through blood products
Acronym	YP-RCT
Scientific Title	The efficacy of psychological approaches to HIV patients infected through blood products; A randomized, parallel-group comparison exploratory study.
Scientific Title:Acronym	YP-RCT
Region	Japan

Condition
Condition	HIV infection, Hemophilia, von Willebrand disease
Classification by specialty	Hematology and clinical oncology Infectious disease Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate mental health and mood for Focusing-Oriented Therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Mental health: General Health Questionnaire 28, GHQ-28 -Mood: Profile of mood states(2nd edition), POMS2
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Focusing Oriented therapy(6 sessions)
Interventions/Control_2	Conversation with clinical psychologist(3 sessions) and Focusing Oriented therapy(3 sessions)
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) HIV patients infected through blood products 2) Over 20 years of age 3) Patient who obtains the agreement of participating in this study
Key exclusion criteria	1) Patient already has received psychotherapy or counseling, and those might be interrupted by receiving this study. 2) Patient not to be able to psychotherapy for severe physical or mental state. 3) Patient who judge not to be able to participate by the principal investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kensuke Middle name Last name Komatsu
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Zip code	162-8655
Address	Toyama, Shinjyuku-ku Tokyo
TEL	03-3202-7181
Email	kkomatsu@acc.ncgm.go.jp

Public contact
Name of contact person	1st name Secretariat Middle name Last name Clinical Sciences
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Zip code	162-8655
Address	Toyama, Shinjyuku-ku Tokyo
TEL	03-3202-7181
Homepage URL
Email	rinrijm@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Japan Foundation for AIDS Prevention
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	Secretariat of Clinical Sciences, National Center for Global Health and Medicine
Address	1-21-1 toyama shinjuku-ku, Tokyo
Tel	03-3202-7181
Email	rinrijm@hosp.ncgm.go.jp

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	国立国際医療研究センター

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 20 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	34
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	Terminated
Date of protocol fixation	2018 Year 06 Month 20 Day
Date of IRB	2018 Year 07 Month 26 Day
Anticipated trial start date	2018 Year 09 Month 13 Day
Last follow-up date	2021 Year 02 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 15 Day
Last modified on	2021 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043647