UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038294 |
|---|---|
| Receipt number | 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 | 2021/05/11 11:13:20 |
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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
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
rinrijm@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043647
