Protocol summary

Study aim
Determining the effectiveness of schema therapy on emotional deprivation, abandonment and quality of life in girls suffering from emotional failure who are students of Qom Azad University
Design
A randomized clinical trial with a control group and a mosaic group on 30 female students with emotional breakdown. A simple randomization method was used for randomization.
Settings and conduct
This study is conducted in Islamic Azad University, Qom branch, female students with emotional failure enter the study. We will place the students in two groups of 15 people randomly. The experimental group will receive the schema therapy package. The control group will not be affected by any experiment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The participants must be female and students of Islamic Azad University of Qom and have symptoms of emotional deprivation and be willing to participate in the study and implementation of treatments. Exclusion criteria: participants who did not experience emotional failure and those who did not wish to participate in the study.
Intervention groups
In this study, the intervention group participates in 11 schema therapy sessions. Each session is held for one hour and is performed weekly, and the content of the sessions is designed based on the principles and cognitive techniques of schema therapy. The control group received no specific therapeutic intervention and only usual and standard care, including general counseling or other standard services that may be available.
Main outcome variables
Emotional deprivation, abandonment, quality of life, emotional failure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240725062541N1
Registration date: 2024-08-15, 1403/05/25
Registration timing: prospective

Last update: 2024-08-15, 1403/05/25
Update count: 0
Registration date
2024-08-15, 1403/05/25
Registrant information
Name
Maryam Safarlo
Name of organization / entity
Islamic Azad University, Semnan branch
Country
Iran (Islamic Republic of)
Phone
+98 25 3285 3521
Email address
maryamsafarlo83@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-20, 1403/05/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of schema therapy on emotional deprivation, abandonment and quality of life in girls with emotional failure, students of Qom Azad University
Public title
The effectiveness of schema therapy on emotional deprivation, abandonment and quality of life in girls with emotional failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants should have symptoms of emotional deprivation. Participants must have experienced an emotional failure in the recent past. Participants must be girls and students of Islamic Azad University of Qom. Candidates must be willing to participate in the study and implement treatments.
Exclusion criteria:
Participants who did not experience an emotional failure were not included in the study. People with severe mental disorders (such as schizophrenia, bipolar disorder, etc.) are excluded from the study. Participants who have previously undergone similar treatments are not included in this study. People who do not want to participate in the study will not be included in the study. People who are unable to regularly attend therapy sessions are excluded from the study.
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: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method was used to randomize the participants. After determining 30 people as a sample, each participant was randomly assigned to one of the two intervention groups (schema therapy) or the control group. For this purpose, numbers 1 to 30 were assigned to each of the participants, and then using a random number table or computer software, the numbers of each participant were randomly selected and assigned to one of the two groups. In this process, the randomization unit was individual, in the sense that each person was independently assigned to the intervention or control group; Therefore, the entire randomization process was performed in a simple manner without initial grouping to ensure that there was no bias in the allocation of participants to 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 Semnan Azad University
Street address
Islamic Azad University, University Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2024-07-30, 1403/05/09
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.059

Health conditions studied

1

Description of health condition studied
Emotional Failure
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Abandonment
Timepoint
Before starting the intervention and after completing 11 intervention sessions.
Method of measurement
Young's early maladaptive schema questionnaire (2003)

2

Description
Emotional Deprivation
Timepoint
Before starting the intervention and after completing 11 intervention sessions.
Method of measurement
Young's early maladaptive schema questionnaire (2003)

3

Description
Quality of Life
Timepoint
Before starting the intervention and after completing 11 intervention sessions.
Method of measurement
36-question quality of life questionnaire (SF-36)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this research, the experimental group will receive schema therapy in 10 one-hour sessions for one month. In the initial stages of schema therapy, the focus is on communicating and empathizing with clients and familiarizing with the basic concepts of primary maladaptive schemas. The assessment of the initial situation of the group and conceptualization of the problem is done according to the schema-oriented approach. Then, clients are introduced to the evolutionary origins and domains of schemas, and cognitive techniques such as schema validity test and a new definition of schema confirming evidence are taught. In the following, maladaptive schemas and ineffective coping responses will be identified, and opportunities will be provided to identify and release blocked emotions. With the progress of treatment, dysfunctional schemas and coping styles are modified and new strategies are practiced to establish healthy communication and replace maladaptive behaviors with efficient ones. In the end, the effectiveness of schema therapy is evaluated and the barriers to behavior change are investigated and the treatment results are summarized.Send feedbackSide panelsHistorySaved
Category
Treatment - Other

2

Description
Control group: The control group does not receive any intervention and serves as a point of comparison in the study. In other words, this group only experiences standard and routine care, and no additional treatment or intervention related to the subject of the study is applied to them during the research period. The conditions of the control group are maintained in such a way that its results can be compared with the intervention group that is undergoing schema therapy treatment. The purpose of this method is to provide a basis for comparing and accurately evaluating the effects of schema therapy.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Qom branch
Full name of responsible person
Gholamreza Najafi
Street address
Islamic Azad University Qom branch, University Boulevard, Pardisan, Qom
City
Qom
Province
Ghoum
Postal code
3749113191
Phone
+98 25 3280 5797
Email
qom@cms.iau.ir
Web page address
https://qom.iau.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Shahab Moradi
Street address
Islamic Azad University, University Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
shahabmoradi66@gmail.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, Semnan branch
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, Semnan branch
Full name of responsible person
Maryam Safarlo
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 43, 15 meters second, Safashehr
City
Qom
Province
Ghoum
Postal code
3716986597
Phone
+98 25 3285 3521
Email
maryamsafarlo83@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Reza Samadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
Samadi.rmb@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Maryam Safarlo
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 43, 15 meters second, Safashehr
City
Qom
Province
Ghoum
Postal code
3716986597
Phone
+98 25 3285 3521
Email
maryamsafarlo83@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic data and the results of the main outcome of the research can be shared after de-identifying and preserving the privacy of individuals.
When the data will become available and for how long
Data can be made available 6 months after results are printed and after removing personally identifiable information.
To whom data/document is available
Study data and documentation will be available to researchers and researchers working in accredited academic and scientific institutions. These people can access the data by submitting a request and after reviewing and approving the request.
Under which criteria data/document could be used
Research data and documents can be used for scientific and research purposes. Users must undertake to keep de-identified data confidential and to publish the results of analyzes in peer-reviewed scientific journals. Requests must be submitted in writing and include a full description of the purpose, methods, and type of analysis. After review and approval, users should share the results with the principal investigator to confirm the validity and accuracy of the analyses.
From where data/document is obtainable
If you need the data, write to maryamsafarlo83@gmail.com.
What processes are involved for a request to access data/document
After receiving the request and reviewing it by the main researcher, the data will be sent to the applicant along with a letter of commitment stating that the data will not be published without the name of the main researcher within a maximum of 5 days.
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