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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028454
Receipt No. R000032575
Scientific Title The study on an intensive group psychotherapy for HIV positive patients
Date of disclosure of the study information 2017/08/01
Last modified on 2019/01/31

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Basic information
Public title The study on an intensive group psychotherapy for HIV positive patients
Acronym Group psychotherapy for HIV positive patients
Scientific Title The study on an intensive group psychotherapy for HIV positive patients
Scientific Title:Acronym Group psychotherapy for HIV positive patients
Region
Japan

Condition
Condition HIV infection
Classification by specialty
Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To stduy the influence of a group psychotherapy on HIV positive patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes psychological test after group psychotherapy
Key secondary outcomes case study of the group psychotherapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 once-a-week group psychotherapy
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria fluent japanese speaking
being in an individual psychotherapy
able to participate in the group psychotherapy at least for 6 months
Key exclusion criteria participating with some reason other than psychotherapy
being a relative/partner/friend of other participants
when judged unsuitable for the study
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshihiko Yasuo
Organization Osaka National Hospital
Division name Department of Clinical Psychology
Zip code
Address 2-1-14, Hoenzaka, Chuo-ku, Osaka
TEL 06-6946-1331
Email tyasuo@onh.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toshihiko Yasuo
Organization Osaka National Hospital
Division name Department of Clinical Psychology
Zip code
Address 2-1-14, Hoenzaka, Chuo-ku, Osaka
TEL 06-6942-1331
Homepage URL
Email tyasuo@onh.go.jp

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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
2017 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 14 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2019 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032575

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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