Determine the effectiveness of reality therapy on decreasing marital conflict among couples
Design
In this research, 100 eligible patients referring to voluntary and counseling center for HIV will be chosen purposefully and a code will be allocated to each one of them. Then, patients randomly will divide into two control and intervention groups. Block randomization and intervention is group counseling
Settings and conduct
It is a randomized controlled clinical trial without blinding. Setting and conduct: voluntary and counseling testing center of Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
It's been 6 months since marriage; have psychological problem according to self report.
Intervention groups
7 section of group counseling for intervention group; control group: receiving Iranian HIV protocol
Main outcome variables
Helping to resolve marital conflicts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180610040037N1
Registration date:2018-07-23, 1397/05/01
Registration timing:registered_while_recruiting
Last update:2018-07-23, 1397/05/01
Update count:0
Registration date
2018-07-23, 1397/05/01
Registrant information
Name
Seyed Ali Dehghan maneshadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 1296
Email address
a_dehghanm@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-10-07, 1397/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of reality therapy on decreasing marital conflict among couples living with HIV/AIDS
Public title
The effectiveness of reality therapy on decreasing marital conflict
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Six months have passed since couples married.
Being Iranian
Reading and writing ability
Written consent
Exclusion criteria:
Absence in medical sessions
Have psychological problem according to self report
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
First, the sampling will be available and according to the active records in the center. Then they will be divided into two groups based on random blocks. Also for statistical matching, the statistical tests are used to match the underlying variables The randomization method is done using block randomization so that the sample size of both groups is equal.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Medical Sciences of Tehran
Street address
Central Office of Tehran University of Medical Sciences, Corner of Ghodd Street, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.TUMS.VCR.REC.1397.156
Health conditions studied
1
Description of health condition studied
Human immunodeficiency virus
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Reducing Marital Conflict
Timepoint
At the beginning of the study (before the intervention) at the end of the study and 45 days after the completion of the study
Method of measurement
Marital conflicts questionnaire, this questionnaire was prepared by Torabi and Sanaei (1996).
Secondary outcomes
1
Description
Increase sex
Timepoint
At the beginning of the study (before the intervention) at the end of the study and 45 days after the completion of the study
Method of measurement
Marital conflicts questionnaire, this questionnaire was prepared by Torabi and Sanaei
Intervention groups
1
Description
In the intervention group of people living with HIV we hold 7 consultation sessions weekly based on reality therapy .The time of each session is 90 minute.
Category
Behavior
2
Description
Control group: in the control group they will receive just routine voluntary and counseling protocol for HIV consultation
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Behavioral Disease Counseling Centers
Full name of responsible person
Dr Seyd Ali Dehghan Menshadi
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
a_dehghanm@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyd Ali Dehghan Menshadi
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
a_dehghanm@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyd Ali Deghan Menshadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
a_dehghanm@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Dehghan Menshadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
a_dehghanm@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Dehghan Menshadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
a_dehghanm@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
as an English article we published data .
When the data will become available and for how long
12 month later
To whom data/document is available
Iranian research center for HIV/AIDS
Under which criteria data/document could be used
path analysis
From where data/document is obtainable
Iranian research center for HIV/AIDS
What processes are involved for a request to access data/document