The effect of self-compassion training on mental well-being and life satisfaction in women with experience of divorce
Design
This study is a non-blinded clinical trial. The research population includes all divorced women registered in the CIB system of the Ilam health center and marital and divorce offices in Ilam, 2017. Seventy eligible patients will be selected conveniently and will randomly be assigned to two intervention and control groups.
Settings and conduct
This study will be conducted at the marriage and divorce offices of the Ilam city. Before the start of the study, the participants will be provided with the questionnaires by the researcher's colleague. The intervention group will receive self-compassion training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ; Experience of divorce just once
Exclusion criteria: using psychotropic drugs; Not having at least reading literacy (illiteracy)
Intervention groups
The intervention group will receive eight 90-minute group education sessions of compassion training (one session in a week).
The control group will not receive any intervention.
Main outcome variables
Psychological well-being, life satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N106
Registration date:2018-11-20, 1397/08/29
Registration timing:registered_while_recruiting
Last update:2018-11-20, 1397/08/29
Update count:0
Registration date
2018-11-20, 1397/08/29
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-16, 1397/08/25
Expected recruitment end date
2019-02-14, 1397/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-compassion training on mental well-being and life satisfaction in women with experience of divorce
Public title
The effect of self-compassion training on mental well-being and life satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The occurrence of divorce during the past six to eighteen months
Experience of divorce just once
Average level or lower of life satisfaction (Score less than 25 of life satisfaction questionnaire)
Medium and low emotional well-being (score of emotional well-being structure from subjective well-being questionnaire be less than 37)
Exclusion criteria:
using of psychotropic drugs
Not having at least reading literacy (illiteracy)
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization by random number table (via code receipt)
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-10-10, 1397/07/18
Ethics committee reference number
IR.KUMS.REC.1397.527
Health conditions studied
1
Description of health condition studied
Life satisfaction
ICD-10 code
F98.9
ICD-10 code description
Unspecified behavioural and emotional disorders with onset usually occurring in childhood and adolescence
Primary outcomes
1
Description
Mental well-being
Timepoint
At the beginning and at the end of the study
Method of measurement
Subjective Well Being Scale (SWS)
2
Description
Life satisfaction
Timepoint
At the beginning and at the end of the study
Method of measurement
Satisfaction with Life Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive eight 90-minute group education sessions of compassion training (one session in a week).
Category
Lifestyle
2
Description
The control group will not receive any intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Marriage and divorce offices
Full name of responsible person
Elham Fatholahi
Street address
Shahid Keshary Square, Azadi Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6931613846
Phone
+98 84 3222 8268
Email
elhamfat2016@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Elham Fatholahi
Position
MSc in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
elhamfat2016@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marziyeh Kaboudi
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
fkoboudim@kums.as.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Elaham fatholahi
Position
Master of Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
elhamfat2016@gmail.com
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
No - There is not a plan to make this available
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
If the data can be helpful in new clinical trials, it will be available to the authors of the articles
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail