Determining the effectiveness of emotional schema therapy on feelings of joylessness and psychological distress in women with domestic violence experience.
Design
The clinical trial with an experimental group and a control group, single blind, sample size of 30 people, randomized, phase 2, lottery method was used for randomization.
Settings and conduct
Study location: Parse Counseling Center was in Robat Karim. The study population: all women with domestic violence experience who had referred to counseling and welfare centers in the southwest of Tehran province in 2021; One-sided blinding type; Blinding method: Those involved in the study (participants) assumed that all participants would receive the intervention, even if some did not.
Participants/Inclusion and exclusion criteria
Inclusion criteria: married women who are victims of one of the types of domestic violence as diagnosed by a forensic doctor, age range between 20 and 50 years, having literacy, ability to participate in meetings, willingness and informed consent to participate in the research.
Non-inclusion criteria: suffering from an acute mental disorder, having obvious physical or psychological symptoms, taking psychiatric drugs and having substance abuse at the time of the research, simultaneous participation in other psychotherapy sessions.
Intervention groups
Intervention group: Emotional schema therapy; Emotional schema therapy training sessions of 12 90-minute sessions based on Leahy's training package (2016) were conducted individually on the experimental group.
Control group:
No intervention was done for the control group.
Main outcome variables
Anhedonia;
psychological distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230517058218N1
Registration date:2023-07-09, 1402/04/18
Registration timing:retrospective
Last update:2023-07-09, 1402/04/18
Update count:0
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
Afarin AghaMohammadSadegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2229 7424
Email address
afi.sadeghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-10, 1400/02/20
Expected recruitment end date
2021-09-11, 1400/06/20
Actual recruitment start date
2021-06-15, 1400/03/25
Actual recruitment end date
2021-10-07, 1400/07/15
Trial completion date
2022-05-17, 1401/02/27
Scientific title
The effectiveness of emotional schema therapy on feeling of anhedonia and psychological distress of women with domestic violence experience
Public title
The effectiveness of emotional schema therapy on women with domestic violence experience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women who are the victims of one types of domestic violence as diagnosed by forensic medicine
Age range between 20 and 50 years
Being literate
Ability to participate in meetings
Willingness and informed consent to participate in the research
Exclusion criteria:
Suffering from an acute psychiatric and physical illness at the time of the research
The existence of cognitive disorders and weakness in cognitive function
Taking psychiatric drugs and having substance abuse at the time of the study
Simultaneous participation in other psychotherapy sessions
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
29
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random assignment to the intervention and control groups was to place 30 cards in a box with the letters of the English alphabet "M" and "C" equally written on them. Each patient randomly selected a card and entered the intervention or control group according to the letter written on the card.
Blinding (investigator's opinion)
Single blinded
Blinding description
Those involved in the study (participants) assumed that all participants received the intervention, although some did not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Department of Psychology; Faculty of Psychology; Tehran Islamic Azad University
Street address
Second West Unit, No 5, after Duquz Crossroad, Shahid Mahmoud Nouryan St, North Dibaji, Farmaniyeh
City
Tehran
Province
Tehran
Postal code
1953664415
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.IAU.TMU.REC.1401.218
Health conditions studied
1
Description of health condition studied
Anhedonia-psychological distress
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Anhedonia score in Snaith-Hamilton's hedonic questionnaire (1995)
Timepoint
At the beginning of the study (before the start of the intervention) and after the treatment protocol
Method of measurement
Snaith-Hamilton's hedonic questionnaire (1995)
2
Description
Psychological distress score in Kessler's Psychological Prescience Questionnaire (2002)
Timepoint
At the beginning of the study (before the start of the intervention) and after the treatment protocol
Intervention group: In this research, the experimental group received 12 sessions of 90-minute emotional schema therapy, based on Leahy's educational package (2016), individually.
Category
Other
2
Description
Control group: It did not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Parse Counseling and Welfare Center
Full name of responsible person
Mansoor Ali Mahdi
Street address
Imam Reza Complex, Amin 1st Alley, Jihad Street
City
Robat Karim
Province
Tehran
Postal code
3761113498
Phone
+98 21 5688 8312
Email
Parseh.psy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Tehran Medical Science Unit , Tehran ,Iran 021-22006660-7, Address:Tehran Islamic Azad University Of Medical Sciences Building Intersection Of Karimi St. Shahid Mosivand St. Shariati St . Tehran Postcal code : 1916893813
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
alimehdi.mansoor@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran Azad Islamic 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
Islamic Azad University
Full name of responsible person
Mansoor Ali Mahdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran Islamic Azad University Of Medical Sciences Building; Intersection Of Karimi St.; Shahid Mosivand St.; Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
alimehdi.mansoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mansoor Ali Mahdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran Islamic Azad University Of Medical Sciences Building; Intersection Of Karimi St.; Shahid Mosivand St.; Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
alimehdi.mansoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afarin AghaMohammad Sadegh
Position
Clinical master's student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Second West Unit,No. 5,after Duquz Crossroad, Shahid Mahmoud Nouryan St., North Dibaji, Farmaniyeh
City
Tehran
Province
Tehran
Postal code
1953664415
Phone
+98 21 2229 7424
Email
afi.sadeghi@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
No - There is not 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
Not applicable
Title and more details about the data/document
The data related to this research is available as an Excel file without mentioning identity information.
When the data will become available and for how long
After publishing the results.
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Responsible author: Mansour Ali Mahdi
Assistant Professor of Psychology, Islamic Azad University, Tehran Medical Sciences Unit, Tehran, Iran. Phone: 7-22006660, Address: Shariati St., Shahid Mosivand St., intersection of Karimi St., Tehran Islamic Azad University of Medical Sciences Building, Postal Code: 1916893813, Email:alimehdi.mansoor@gmail.com
What processes are involved for a request to access data/document
Documents or files will be provided as soon as possible after contacting the responsible author.