Protocol summary

Study aim
Determining the Effectiveness of Anger Management Skills Training on Anger among HIV Patients Referring to Kerman Critical Care Reference Centers, Counseling Center in 2018
Design
Randomized clinical trial with community-based control group without blindness
Settings and conduct
This study is conducted to determine the effectiveness of anger control skills of HIV patients in Kerman University of Medical Sciences. The subjects are divided into two groups of control and intervention by simple randomization method.
Participants/Inclusion and exclusion criteria
Age at least 18 years, A history of HIV infection, Reading and writing literacy, No psychological intervention.
Intervention groups
This research is an experimental study with intervention and control groups. The population of the study consists of 173 individuals who are active in the Behavioral Reference Centers Counseling Center. The research samples are comprised of 60 individuals who meet the criteria for entry. In this research, the samples are randomly divided into two intervention and control group with 30 people in each one. Anger management training content are implemented using similar studies in four sessions of 75 to 90 minutes
Main outcome variables
anger management

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181105041566N1
Registration date: 2019-02-12, 1397/11/23
Registration timing: prospective

Last update: 2019-02-12, 1397/11/23
Update count: 0
Registration date
2019-02-12, 1397/11/23
Registrant information
Name
Mehri Lotfalizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3222 1503
Email address
m.lotfalizadeh-office@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing effectiveness of anger management skills training on the anger of people living with HIV Referring to Referral behavioral diseases counseling center affiliated with Kerman University of Medical Sciences Reference
Public title
The Effectiveness of Anger Management Skills Training on Anger among HIV Patients Referring to Behavioral Disease Counseling Center
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
HIV Patients Referring to Kerman Clinical Reference Center for Cognitive Behavioral Diseases
Exclusion criteria:
No psychological intervention
Age
From 18 years old to 63 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. A random sequence is used after using the convenience sampling method. The questionnaire is filled for all referring people on different days of the week until completion the sample size. Then we name the groups A and B, then we put a questionnaire in group A and one in the group B. Hiding random assignment: In this method, without knowing the names of the two groups, after the people have been assigned to both groups, one group is called intervention and the other is called control.
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
Kerman University of Medical Sciences
Street address
West Motahari avenue, Kerman, opposite the Alley No. 25 Reference Center for Counseling for Behavioral Illnesses
City
Kerman
Province
Kerman
Postal code
7617667338
Approval date
2018-12-10, 1397/09/19
Ethics committee reference number
IR.KMU.REC.1397.345

Health conditions studied

1

Description of health condition studied
anger management in people with HIV
ICD-10 code
B20
ICD-10 code description

Primary outcomes

1

Description
The percentage of people with anger score greater than 75 in the Spielberger questionnaire
Timepoint
Evaluation of the effect of training anger skills one month after intervention
Method of measurement
Spielberger's Rage Inventory is an instrument for measuring anger

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: 30 HIV-infected people who are selected by simple random method, learn the skills of anger control in four sessions
Category
Rehabilitation

2

Description
Control group: Thirty people with HIV do not receive any interventions.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman Counseling Center for Behavioral Patients Reference
Full name of responsible person
Mehri Lotfalizadeh
Street address
West Motahari avenue, Kerman, opposite the Alley No. 25 Reference Center for Counseling for Behavioral Illnesses
City
Kerman
Province
Kerman
Postal code
7617667338
Phone
+98 34 3223 1982
Email
mh.lotfalizadeh@yahoo.com
Web page address
https://fa.irct.ir/user/trial/35135/update/recruitment_center

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehri Lotfalizadeh
Street address
West Motahari avenue, Kerman, opposite the Alley No. 25 Reference Center for Counseling for Behavioral Illnesses
City
Kerman
Province
Kerman
Postal code
7617667338
Phone
+98 34 3222 1503
Email
mh.lotfalizadeh@yahoo.com
Web page address
https://fa.irct.ir/user/trial/35135/update/sponsor
Grant name
no
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mehri Lotfali Zadeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
West Motahari Ave. Kerman, opposite Alley 25 Centers for Reference Behavioral Disease Counseling Center
City
kerman
Province
Kerman
Postal code
7617667338
Phone
+98 34 3223 1982
Email
mh.lotfalizadeh@yahoo.com
Web page address
https://fa.irct.ir/user/trial/35135/update/public_queries_contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehri Lotfali Zadeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
West Motahari Ave. Kerman, opposite Alley 25 Centers for Reference Behavioral Disease Counseling Center
City
kerman
Province
Kerman
Postal code
7617667338
Phone
+98 34 3223 1982
Email
mh.lotfalizadeh@yahoo.com
Web page address
https://fa.irct.ir/user/trial/35135/update/scientific_queries_contact

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehri Lotfalizadeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
West Motahari avenue, Kerman, opposite the Alley No. 25 Reference Center for Counseling for Behavioral Illnesses
City
Kerman
Province
Kerman
Postal code
7617667338
Phone
+98 34 3222 1503
Email
mh.lotfalizadeh@yahoo.com
Web page address
https://fa.irct.ir/user/trial/35135/update/data_updater_contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data that reduces anger in an infected person will be shared.
When the data will become available and for how long
Starting a year after publishing the results
To whom data/document is available
Only available for people working in academic and academic institutions
Under which criteria data/document could be used
Creating ways to help HIV patients to reduce communication problems can be used as a data article
From where data/document is obtainable
mh.lotfalizadeh@yahoo.com
What processes are involved for a request to access data/document
A year after printing, the results are shared via email
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