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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038294
Receipt No. R000043647
Scientific Title The efficacy of psychological approaches to HIV patients infected through blood products; A randomized, parallel-group comparison exploratory study.
Date of disclosure of the study information 2019/10/20
Last modified on 2020/10/26

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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 36
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 No longer recruiting
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
2022 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
2019 Year 10 Month 15 Day
Last modified on
2020 Year 10 Month 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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