The purpose of this study was to determine the effectiveness of cognitive behavioral counseling and mental health on women with multiple spouses.
Design
This study is a randomized controlled trial.The samples are randomly divided into two groups of intervention and control.
Settings and conduct
This study is a randomized clinical trial study that will be referred to Ahwaz East Health Center after submitting a written letter from Ahwaz University of Medical Sciences and receiving a code of ethics from Ahvaz Jundishapur University of Medical Sciences Ethics Committee.
Participants/Inclusion and exclusion criteria
This study is a clinical trial on 90 women in polygamous families with mental health problems. Inclusion criteria included: mental health score higher than
50 based on the SCL -25 mental health questionnaire , women in polygamous families of childbearing age 18 to 45 years , minimum education level is cycle, spouse has mental health. Exclusion criteria include: Women,s unwillingness to continue in collaborating in research, having a history of adverse event in the last 6 months, having a history of Drugs use or Alcohol, Infertile women, Cerebral lesions, mental retardation, taking psychotropic drugs, having underlying disease of hypertension diabetes mellitus .
Intervention groups
The intervention group will receive 8 sessions of 120 minutes weekly Cognitive behavioral Counseling, After the end of counseling period and one month later both group will be assessed again with the mental health questionnaire.The control group will not receive any intervention during the study but they will be offered two sessions of group counseling to follow the ethics of the research
Main outcome variables
Mental health Level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190906044709N1
Registration date:2019-12-22, 1398/10/01
Registration timing:retrospective
Last update:2019-12-22, 1398/10/01
Update count:0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Soghra Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3323 2171
Email address
sghrymrady9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-07, 1398/04/16
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect cognitive behavioral therapy on the mental health of women in polygamous families
Public title
effect cognitive behavioral therapy on the mental health
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Earning a Mental health score higher than 50 on the SCL-25 mental health questionnaire
Women in polygamous families aged 18 to 45 years
minimum cycle education
Lack of severe mental disorders of wife
Exclusion criteria:
women,s unwillingness to continue collaborating in research
Having a history of adverse event in the last 6 months
Having a history of drug or alcohol abuse
Infertile women
Cerebral lesions and mental retardation
Taking psychotropic drugs
Having underlying disease of hypertention , diabetes mellitus
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First, women in polygamous families will be identified through family case studies and completion of screening criteria for entry and exit among women in polygamous families. individuals who qualify for the study will complete a mental health questionnaire. 90 of the women whose mental health is below average with written consent, this will be included in the research. in this study, according to the sample size formula, 90 people were included in the study, then, using random allocation method in each group, using random number table, the creation of 4 blocks will be divided in to two groups of 45 each intervention and control groups.
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
Ethics committee of Ahwaz University of Medical Sciences
Street address
Vcie chancellor for Research, Information Technology, Ahvaz Jundishapur University of Medical Sciences, Ground Floor.
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.AJUMS.REC.1398.095
Health conditions studied
1
Description of health condition studied
Mental health
ICD-10 code
F00-F09
ICD-10 code description
Organic, including symptomatic, mental disorders
Primary outcomes
1
Description
Mental health
Timepoint
Befour Intervention , one month after intervention
Method of measurement
Mental health questionnaire SCL-25
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group eight meeting CBT gets for each session 120 minutes and has structure
Category
Behavior
2
Description
Control group: The control group received no intervention and was on the waiting list.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care center No : 9
Full name of responsible person
Soghra Moradi
Street address
Amini Street., Behbahani Blvd
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Behzad Sharif Makhmal Zadeh
Street address
Univercity City Ahwaz Jundishapur Univercity of Medical Sciences School of Nursing and Midwifery - Midwifery group - Khuzestan Iran
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir
Grant name
Sponsor Vice Chancellor for research Ahwaz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Soghra Moradi
Position
MS.c Student Midwifery Cunselling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Street Esfand, Golestan
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 1544
Email
sghrymrady9@gmail.com
Web page address
http://vchresearch.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon
Position
Master of Midwifery, Lecturer in Midwifery Department, Ahwaz Jundishapur Univercity of Medical Scien
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahwaz, Jundishapur Univercity of Medical Sciences School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 1544
Email
mitratadayon2000@yahoo.com
Web page address
http://ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Soghra Moradi
Position
Student in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 1544
Email
sghrymradi9@gmail.com
Web page address
http://vchersearch.ajums.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
Yes - There is a plan to make this available
Title and more details about the data/document
All peoples data can be shared after it is unrecognizable
When the data will become available and for how long
2 months after the article was published
To whom data/document is available
Anyone interested can access the data
Under which criteria data/document could be used
If used for other research or comparing resuit with other research