Investigating the effect of schema therapy on emotionally damaged women
Design
A clinical trial with a control group, with parallel groups, not blinded, randomized by the method of random allocation law, without phase on 40 patients who are divided into two groups of 20 intervention and control. For randomization, the selection of names from the vase was used without repetition and replacement.
Settings and conduct
A number of 40 eligible people have chosen to enter the plan and randomly and without replacement, the first 20 people will be selected as the intervention group and the second 20 people will be selected as the control group. Cognitive flexibility questionnaires and rumination questionnaires are provided to 40 clients of Baran Counseling Clinic. The intervention group receives schema therapy in addition to the standard treatment. And the control group only received the standard treatment.
Participants/Inclusion and exclusion criteria
Entry requirements: have at least a diploma education, have at least three years of cohabitation, more than six months have passed since the disclosure of their spouse's infidelity, have not applied for divorce due to the issue of their spouse's infidelity, have completed the treatment consent form, while participating They have not attended therapy sessions to receive individual counseling services.
Exit conditions: Divorced due to infidelity of their spouses, having a history of hospitalization in psychiatric hospitals, consuming drugs or alcohol, missing more than two sessions.
Intervention groups
Emotionally damaged women from extramarital relationships
Main outcome variables
Rumination, cognitive flexibility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220507054759N2
Registration date:2022-07-06, 1401/04/15
Registration timing:prospective
Last update:2022-07-06, 1401/04/15
Update count:0
Registration date
2022-07-06, 1401/04/15
Registrant information
Name
Ramin Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3341 2101
Email address
r-zare@iau-arak.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of schema therapy on rumination and cognitive flexibility of women affected emotionally by extramarital affairs
Public title
The effectiveness of schema therapy on rumination and cognitive flexibility of women affected emotionally by extramarital affairs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least a diploma
Have at least three years of living together
It has been more than six months since the revelation of their spouse's infidelity
Do not apply for divorce due to infidelity
Have completed the treatment consent form.
Have not referred for personal counseling services while attending treatment sessions.
Exclusion criteria:
Divorced due to infidelity
Have a history of hospitalization in psychiatric hospitals
Consume drugs or alcohol
Absent for more than two sessions
Age
From 27 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is the rule of random assignment.
The community of this study consists of 40 emotionally damaged working women from extramarital relationships. In this study of 40 people, 20 people will be placed in the intervention group and 20 people will be placed in the control group using the randomization method of the random allocation law. In this way, the names of the people under study will be written and put into the container. And the names are removed from the container one by one without repetition. The first 20 people are considered the intervention group and the second 20 people are considered the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The community of this study consists of 40 emotionally damaged working women from extramarital relationships. In this study of 40 people, 20 people will be placed in the intervention group and 20 people will be in the control group using the method of randomization. And the names are removed from the container one by one without repetition. The first 20 people are considered the intervention group and the second 20 people are considered the control group. For the control group, only the standard treatment is considered. And for the intervention group, schema therapy will be started along with the standard therapy, which will be provided during 8 sessions to teach schemas and coping styles.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic University of Arak Branch
Street address
Amirkabir University Town-3 km of Khomeini Road-Imam Khomeini Boulevard-Imam Khomeini Square-Arak
City
Arak
Province
Markazi
Postal code
۳۸۳۶۱۱۹۱۳۱
Approval date
2022-02-07, 1400/11/18
Ethics committee reference number
IR.IAU.ARAK.REC.1401.030
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Rumination
Timepoint
At the beginning of the study and one month later as the end of the study
Method of measurement
Ruminant Questionnaire
2
Description
Cognitive flexibility
Timepoint
At the beginning of the study and one month later as the end of the study
Method of measurement
Cognitive flexibility questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 people in the intervention group will be given 8 sessions to teach schemas and coping styles. Training and explanation of goals and interventions, the second session of familiarization and introduction of the program and the implementation of the pre-test, the third session of definition of schema therapy and familiarity with schema concepts, the fourth session of training and recognition of primary maladaptive schemas, the fifth session of introducing the domains of primary maladaptive schemas, the session 6th training and understanding the concept of cognitive coordination and ineffective coping responses, 7th session of schema therapy assessment and training, 8th session using cognitive strategies and experiential strategies of schema therapy and teaching pattern breaking methods and post-test implementation and summation. This research team identifies the schemas in the members and then treats the schemas of the people with the available techniques.
Category
Treatment - Other
2
Description
Control group: 20 people in the control group receive only the standard treatment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baran Psychology Counseling Center
Full name of responsible person
Sahar sadeghian
Street address
next to the second floor post office-Roudhan-Tehran
City
Tehran
Province
Tehran
Postal code
3644170967
Phone
+98 21 2267 9213
Email
Saharsadeghian28@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Hassani Joshaghani
Street address
Amirkabir University Town-3 km of Khomeini Road-Imam Khomeini Boulevard-Imam Khomeini Square-Arak
City
Arak
Province
Markazi
Postal code
۳۸۳۶۱۱۹۱۳۱
Phone
+98 86 3341 2101
Email
ahj-ir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Maryam goodarz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Amirkabir University Town-3 km of Khomeini Road-Imam Khomeini Boulevard-Imam Khomeini Square-Arak
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 86 3341 2101
Email
maryamgodarzi575@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin zare
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Ossopational Health
Street address
Amirkabir University Town-3 km of Khomeini Road-Imam Khomeini Boulevard-Imam Khomeini Square-Arak
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 86 3341 2101
Email
r-zare@iau-arak.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam goodarz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Amirkabir University Town-3 km of Khomeini Road-Imam Khomeini Boulevard-Imam Khomeini Square-Arak
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 86 3341 2101
Email
maryamgodarzi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available