UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028454 |
|---|---|
| Receipt number | 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 09:32:31 |
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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
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
tyasuo@onh.go.jp
Public contact
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
tyasuo@onh.go.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032575
