Protocol summary

Study aim
The aim of this study is to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) on self-efficacy and emotion regulation among divorced women in Rasht, Iran. This research seeks to determine the extent to which this psychological intervention improves individuals’ beliefs in their own abilities (self-efficacy) and enhances emotion regulation skills.
Design
This study is a randomized controlled clinical trial (RCT) with a pretest–posttest design including a control group.
Settings and conduct
This study will be conducted after obtaining the necessary approvals from the Welfare Organization (Behzisti) of Rasht. Participants will be recruited from divorced women covered by or referred to welfare-affiliated centers in Rasht. After screening based on inclusion and exclusion criteria, eligible participants will be randomly assigned to the experimental and control groups. The Cognitive Behavioral Therapy (CBT) intervention will be delivered in group sessions at counseling centers affiliated with the Welfare Organization.
Participants/Inclusion and exclusion criteria
Inclusion Criteria Being divorced_Minimum education level: high school diploma_No severe physical illnesses No severe mood or emotional disorders _Age between 20 and 50 years _At least 6 months have passed since divorce Exclusion Criteria_Absence from intervention sessions_Lack of willingness to participate in sessions_Incomplete completion of questionnaires_Missing more than two sessions_Failure to sign the informed consent form and lack of cooperation with the therapist
Intervention groups
Experimental Group:Divorced women who will receive Cognitive Behavioral Therapy (CBT) in a structured session format. Control Group:Divorced women who will not receive any psychological intervention during the study period .
Main outcome variables
Self-efficacy and Emotion Regulation:

General information

Reason for update
Acronym
CBT_ERSE
IRCT registration information
IRCT registration number: IRCT20251213068297N1
Registration date: 2026-07-06, 1405/04/15
Registration timing: retrospective

Last update: 2026-07-06, 1405/04/15
Update count: 0
Registration date
2026-07-06, 1405/04/15
Registrant information
Name
Seyedeh Fatemeh Dinparast Konesestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3360 2290
Email address
taravatdinparast2002@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-16, 1405/02/26
Expected recruitment end date
2026-05-18, 1405/02/28
Actual recruitment start date
2026-05-18, 1405/02/28
Actual recruitment end date
2026-05-20, 1405/02/30
Trial completion date
2026-06-15, 1405/03/25
Scientific title
The Effectiveness of Cognitive Behavioral Therapy on Self-Efficacy and Emotion Regulation in Divorced Women
Public title
Examining Self-Efficacy and Emotion Regulation in Divorced Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The condotion for entering the study is to be divorced. The condition for entering The research is to have at least a high school diploma.
Exclusion criteria:
The main exclusion condition for the study is having a severe physical illness. The exclusion condition for the study is having a severe mood and emotional illness
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization with a 1:1 allocation ratio was used, and the unit of randomization was the individual participant. Block and stratified randomization were not applied. To generate the random allocation sequence, an equal number of slips labeled “intervention” and “control” were prepared, thoroughly mixed, and placed in a container. Eligible participants were then assigned sequentially to the intervention or control group according to the lottery result until the required sample size for each group was reached. Before the lottery was conducted, group allocation was unknown to both the researcher and the participants, and the assignment was revealed only after the lottery was completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A two-arm randomized controlled clinical trial with a pretest–posttest design. Eligible participants will be randomly assigned to either the intervention group (Cognitive Behavioral Therapy) or the control group. Self-efficacy and emotion regulation will be assessed before and after the intervention.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Tonekabon Branch
Street address
Yas Alley, Payam Noor Street, Sefid Rud Township, Rasht
City
Rasht
Province
Guilan
Postal code
4198913969
Approval date
2026-05-16, 1405/02/26
Ethics committee reference number
IR.IAU.TON.REC.1405.032

Health conditions studied

1

Description of health condition studied
Lacks
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Total self-efficacy score measured using the Sherer General Self-Efficacy Scale (SGSES).
Timepoint
Baseline (Pre-test): Before the start of the Cognitive Behavioral Therapy (CBT) intervention.Post-test: Immediately after completion of the CBT sessions.
Method of measurement
Sherer General Self-Efficacy Scale (SGSES)

2

Description
Total cognitive emotion regulation score measured using the Cognitive Emotion Regulation Questionnaire (CERQ).
Timepoint
Baseline (Pre-test): Before the start of the Cognitive Behavioral Therapy (CBT) intervention.Post-test: Immediately after completion of the CBT sessions.
Method of measurement
Cognitive Emotion Regulation Questionnaire (CERQ)

Secondary outcomes

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Intervention groups

1

Description
Intervention group: Participants in this group will receive group-based Cognitive Behavioral Therapy (CBT). The intervention consists of 8 weekly sessions, each lasting 60 minutes, delivered by a psychologist trained in Cognitive Behavioral Therapy. The session content includes identifying dysfunctional beliefs and cognitive distortions, understanding the relationship between thoughts, emotions, and behaviors, identifying negative automatic thoughts, increasing emotional awareness, modifying maladaptive thinking patterns, recognizing different emotions and learning emotion regulation strategies, strengthening self-efficacy, enhancing the sense of control over life, and completing homework assignments to practice the learned skills. The intervention will be conducted over 8 weeks.
Category
Lifestyle

2

Description
Control group: Participants in this group will not receive any structured psychological intervention or Cognitive Behavioral Therapy during the study period and will receive only the usual available services. After completion of the study and data collection, a summary of the Cognitive Behavioral Therapy educational content will be offered to participants in this group if they wish.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
General Directorate of Welfare of Guilan Province
Full name of responsible person
Seyedeh Fatemeh Dinparast
Street address
Yas Street_ Payamenoor Alley _ Rasht
City
Rasht
Province
Guilan
Postal code
4198913969
Phone
+98 13 3360 2290
Email
Taravatdinparast2002@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Ghane
Street address
Yas Street _ Payamenoor Alley _ Rasht
City
Rasht
Province
Guilan
Postal code
4198913969
Phone
+98 13 3360 2290
Email
Taravatdinparast2002@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
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
Seyedeh Fatemeh Dinparast
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Yas Street _ Payamenoor Alley _ Rasht
City
Rasht
Province
Guilan
Postal code
4198913969
Phone
+98 13 3360 2290
Email
Taravatdinparast2002@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedeh Fatemeh Dinparast
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Yas Alley, Payam Noor Street, Rasht
City
Rasht
Province
Guilan
Postal code
4198913969
Phone
+98 13 3360 2290
Email
Taravatdinparast2002@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedeh Fatemeh Dinparast
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychologist
Street address
Yas Alley, Payame Noor Street , Rasht
City
Rasht
Province
Guilan
Postal code
4198913969
Phone
+98 13 3360 2290
Email
Taravatdinparast2002@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
No - There is not 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
No - There is not 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 data of this study include demographic information and scores obtained from self-efficacy and emotion regulation questionnaires among divorced women participating in the study. The dataset also includes pre-test and post-test results for both the intervention (CBT) and control groups. All individual participant data will be fully de-identified prior to analysis and sharing, ensuring that no personal identifiers such as names, phone numbers, or addresses are included in the dataset. If data sharing is permitted, the full anonymized raw dataset, including questionnaire scores and non-identifiable demographic variables, may be made available to other researchers. However, any identifying information will not be shared under any circumstances. Alternatively, in some cases, only data related to primary outcomes (self-efficacy and emotion regulation scores) may be shared for secondary analyses. Data sharing will be conducted solely for research purposes and upon formal request, in accordance with ethical research guidelines.
When the data will become available and for how long
10 years after access begins
To whom data/document is available
Welfare Organization and Psychologists
Under which criteria data/document could be used
It can be used to use data results and use treatment protocols and in situations of helping others.
From where data/document is obtainable
The data and study-related documents may be made available upon reasonable scientific request and in accordance with confidentiality requirements. Interested researchers may submit their requests to the Principal Investigator, the relevant office of State Welfare Organization of Iran in Rasht, or the Islamic Azad University where the study is conducted. Following review and approval by the appropriate authorities and in compliance with ethical requirements, the requested data will be shared in a coded and de-identified format, with all participant-identifying information removed.
What processes are involved for a request to access data/document
Research data will be collected, coded, and stored confidentially. Any request for access to the study data or related documents must be submitted to the principal investigator and will be reviewed in accordance with the relevant ethical and institutional requirements. Upon approval by the appropriate ethics committee or research authority, the requested data will be provided in a de-identified form, ensuring that no personally identifiable information of participants is disclosed. All study documents will be securely stored, and access will be restricted to authorized members of the research team only.
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