The aim of this study is to investigate the effectiveness of 24-section 3-month cognitive rehabilitation on cognitive functioning of HIV positive patients
Design
Current study is a clinical trial with parallel group design and 60 eligible persons will randomly assign to one of intervention (30)and control group(30)
Settings and conduct
location of conducting current project is Iranian research center for HIV/AIDS(IRCHA) situated in Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-Diagnosed with HIV infection
2-18 < Age > 50
3-No history of CD4 count under 200 cells/mm3
4-No History of hospitalization because of any kind of opportunistic infection
5-Not Co-infected with Hepatitis C
6-No current use of psychiatric medication
7-No drug/Alcohol use/abuse(Abstinent for at least 2 years)
8-History of any kind of head trauma/Injury
9-Consented for participation
Exclusion criteria:1-Significant visual and auditory damage
2-Not diagnosed with severe anxiety or depression
Intervention groups
The participants in the intervention group for 3 months performing computerized cognitive training. participants of the control group will be asked to maintain their levels of physical activity during study period.
Main outcome variables
Cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100601004076N22
Registration date:2018-09-09, 1397/06/18
Registration timing:retrospective
Last update:2018-09-09, 1397/06/18
Update count:0
Registration date
2018-09-09, 1397/06/18
Registrant information
Name
Minoo Mohraz
Name of organization / entity
Iranian Research Center for HIV/AIDS, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 7984
Email address
minoomohraz@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Cognitive Rehabilitation Therapy (CRT) on enhancement of executive functions (EF) in patients with HIV-infection (CH)
Public title
Brain cognitive function rehabilitation in HIV-infected patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with HIV infection
18 < Age > 50
No history of CD4 count under 200 cells/mm3
No History of hospitalization because of any kind of opportunistic infection
Not Co-infected with Hepatitis C
No current use of psychiatric medication
No drug/Alcohol use/abuse(Abstinent for at least 2 years)
History of any kind of head trauma/Injury
Consented for participation
Exclusion criteria:
Significant visual and auditory damage
Not diagnosed with severe anxiety or depression
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible volunteers will randomly be assigned to intervention and control groups. randomization will be done by a randomization list that will be generated by computerized software program.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are not informed weather they are in control group or experimental group. They don't know if others are receiving rehabilitation or not.
Placebo
Not used
Assignment
Other
Other design features
Participants are considered as experimental group if they be able to participate in whole 24 rehabilitation sections for 3 months, the remains are determine as control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Tehran University of Medical Sciences
Street address
Central building of TUMS, Ghods St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
0123456789
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3323
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Cognitive function
Timepoint
pre and post study period and 3 months after end up the study
Method of measurement
computerized cognitive test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants will participate in 24 90-minute cognitive rehabilitation sections twice a week including 9 cognitive practices which get harder every section gradually to enhance the effectiveness of the practice on the one's cognition.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian research center for HIV/AIDS(IRCHA)
Full name of responsible person
Minoo Mohraz
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Email
ircha@tums.ac.ir
Web page address
http://ircha.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-presidency for science and technology
Full name of responsible person
Zeinab Farhadi
Street address
33, 5th St., North Kargar St
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8216 1127
Fax
Email
companies@insf.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice-presidency for science and technology
Proportion provided by this source
75
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Minoo Mohraz
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Iranian Research Center for HIV/AIDS (IRCHA), Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1956865432
Phone
+98 21 6694 7984
Email
ircha@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maede sadat Etesami
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Iranian research center for HIV/AIDS,Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1123565479
Phone
+98 21 6658 1583
Email
msetesamy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maede Sadat Etesami
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6694 7984
Email
msetesamy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available