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Investigating the therapeutic intervention of emotional schema therapy on emotional regulation, fear of intimacy and emotional inhibition in couples with depression

Protocol summary

Study aim
Investigating the therapeutic intervention of emotional schema therapy on emotional regulation, fear of intimacy and emotional inhibition in couples with depression
Design
The clinical trial has an experimental group and a control group on 40 couples suffering from depression disorder, randomized, single-blind, and a lottery method is used for randomization.
Settings and conduct
This study is conducted in Mehr and Mah Counseling Center in Semnan, couples suffering from depression disorder are included in the study. Due to the fact that the patients do not know about the group allocation, therefore, a blind strain study is performed. We will place the patients in two groups of 20 people randomly. The experimental group will receive Leahy's emotional schema therapy protocol. The control group will not be affected by any experiment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: obtaining a score above 20 in the Beck depression questionnaire, no history of chronic physical illness, no drug addiction, high school diploma or higher, aged 20 to 45 years. Exclusion criteria: lack of accuracy and attention in doing all the tests and finishing them, unwillingness to participate in the research to do the tests.
Intervention groups
The experimental group will receive 9 sessions of 45-minute emotional schema therapy, based on Leahy's educational package, individually. The control group will not receive any intervention, but after the follow-up period, a training session will be held to comply with ethical issues.
Main outcome variables
Emotional schema therapy, Emotional dysregulation, Fear of intimacy, Emotional inhibition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240611062094N1
Registration date: 2024-06-19, 1403/03/30
Registration timing: prospective

Last update: 2024-06-19, 1403/03/30
Update count: 0
Registration date
2024-06-19, 1403/03/30
Registrant information
Name
fatemeh saeedi
Name of organization / entity
Islamic Azad University, Semnan branch
Country
Iran (Islamic Republic of)
Phone
+98 23 3362 3599
Email address
fatemeh.saeedi19940@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2024-08-31, 1403/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the therapeutic intervention of emotional schema therapy on emotional regulation, fear of intimacy and emotional inhibition in couples with depression
Public title
Investigating the therapeutic intervention of emotional schema therapy on emotional regulation, fear of intimacy and emotional inhibition in couples with depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
No history of psychiatric disorder (other than depression in the group with depressive disorder) No history of chronic physical illness Diploma and above education Age range between 20 and 45 years
Exclusion criteria:
No drug addiction Lack of accuracy and attention in doing all the tests and finishing them Unwillingness to participate in research to perform tests
Age
From 20 years old to 45 years old
Gender
Both
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 random assignment to the intervention and control groups is that in a box with 40 cards on which the English alphabet letters "M" and "C" were written equally, the sample randomly selected a card and According to the letters on the card, they will enter the intervention or control group.
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
2024-05-21, 1403/03/01
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.037

Health conditions studied

1

Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Emotional schema therapy
Timepoint
Before and after 9 sessions of intervention
Method of measurement
Leahy's Emotional Schema Therapy (2016)

2

Description
Difficulties in Emotion Regulation
Timepoint
Before and after 9 sessions of intervention
Method of measurement
Difficulties in Emotion Regulation Scale Gratz & Roemer (2004)

3

Description
Emotional Inhibition
Timepoint
Before and after 9 sessions of intervention
Method of measurement
The brain behavioral inhibition and activation systems (BIS/BAS) questionnaire of Carver and White (1994)

4

Description
Fear of intimacy
Timepoint
Before and after 9 sessions of intervention
Method of measurement
Descutner and Thelen Fear of Intimacy Questionnaire (1991)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this research, the experimental group will receive 9 45-minute sessions of emotional schema therapy, based on the Leahy educational package, individually. The first session: initial assessment of the level of depression and its explanation in the form of empathic relationship. The second session: homework review, emotional validation. The third session: Homework review, emotional validation and challenge with troublesome emotional schemas. The fourth session: Reviewing homework, challenges with schemas. The fifth session: Homework review, fundamental acceptance of emotions. Sixth session: Homework review, strengthening emotional processing. Seventh session: review of homework, beneficial resentment and cognitive restructuring. Eighth session: Homework review, cognitive reconstruction and ninth session: Summary and evaluation.
Category
Treatment - Other

2

Description
Control group: will not receive any intervention, but after the follow-up period, a training session will be held to comply with ethical issues.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr and Mah Counseling Center
Full name of responsible person
Ruqiya Omrani
Street address
unit 3, 4th floor, Nagin complex, Imam Square, Saadi St, Semnan.
City
Semnan
Province
Semnan
Postal code
۳۵۱۷۸۸۴۵۸۵
Phone
+98 23 3332 3565
Email
mehrvamahsemnan@gmail.com

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
Fatemeh Saeedi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 23, Shaheed Mojtaba Saeedi Alley, Shahrek Enghelab
City
Mahdishahr
Province
Semnan
Postal code
3561897434
Phone
+98 23 3362 3599
Email
fatemeh.saeedi19940@gmail.com

Person responsible for scientific inquiries

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

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Fatemeh Saeedi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 23, Shaheed Mojtaba Saeedi Alley, Shahrek Enghelab
City
Mahdishahr
Province
Semnan
Postal code
3561897434
Phone
+98 23 3362 3599
Email
fatemeh.saeedi19940@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Since the research plan is related to a thesis, only the study protocol, clinical study report, and study results will be published. The participant data file contains information about the participants, and due to the preservation of individuals' privacy it cannot be published.
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
The steps of the clinical study, such as the number of participants, the inclusion and exclusion criteria for the research plan, the sampling method, the therapeutic protocol, and the study results, will be detailed in the thesis and article.
When the data will become available and for how long
Data can be made available 6 months after results are published.
To whom data/document is available
Researchers in scientific and academic centers can access the data.
Under which criteria data/document could be used
In order to study or conduct research by mentioning the source.
From where data/document is obtainable
If you need data, write to fatemeh.saeedi19940@gmail.com.
What processes are involved for a request to access data/document
After receiving the request and its review 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 one month.
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