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A comparative study of the effect of emotional schema therapy with cognitive behavioral therapy on quality of life, body image, resilience, and marital satisfaction in women with breast cancer who underwent mastectomy in 2015-2016

Protocol summary

Study aim
Evaluation of the effects of Emotional Schema Therapy on the Quality of Life in Women with Breast Cancer Post-Mastectomy
Design
This study is a randomized clinical trial targeting women diagnosed with breast cancer who have undergone mastectomy. The sample size is 36 participants, and individuals will be placed on a numbered list, then be randomly assigned to the experimental (will receive Emotional Schema Therapy intervention) and control groups (will receive Cognitive Behavioral Therapy) using sealed, opaque, and numbered envelopes, which each participant will select.
Settings and conduct
This study will be conducted at the "Didar Center for Counseling Mental Disorders and Problems" in Isfahan. Data will be collected and analyzed numerically. The instruments used will include standardized questionnaires and scales for measuring quality of life, body image, resilience, and marital satisfaction. Prior to the interventions, participants will be asked to complete the relevant questionnaires. After the therapeutic interventions for a specified duration (8 to 12 sessions), data will be collected again.
Participants/Inclusion and exclusion criteria
Inclusion criteria included women aged 18 to 65 years with a clinical diagnosis of breast cancer, a history of mastectomy, being married or in a marital relationship, and having psychological readiness. Exclusion criteria included the presence of a severe psychiatric disorder and receiving similar treatments.
Intervention groups
Control Group: Participants will undergo Cognitive Behavioral Therapy for a specified duration, spanning 8 to 12 sessions. Intervention Group: Participants will receive Emotional Schema Therapy for a specified duration, also spanning 8 to 12 sessions.
Main outcome variables
Changes in quality of life, body image scale, resilience, and marital satisfaction will be evaluated.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251121068065N5
Registration date: 2026-06-12, 1405/03/22
Registration timing: registered_while_recruiting

Last update: 2026-06-12, 1405/03/22
Update count: 0
Registration date
2026-06-12, 1405/03/22
Registrant information
Name
kavoushgaran kavoushgaran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 718 4680
Email address
atiye.hesary@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-10, 1405/03/20
Expected recruitment end date
2026-09-11, 1405/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of emotional schema therapy with cognitive behavioral therapy on quality of life, body image, resilience, and marital satisfaction in women with breast cancer who underwent mastectomy in 2015-2016
Public title
A comparative study of the effect of emotional schema therapy with cognitive behavioral therapy on quality of life, body image, resilience, and marital satisfaction in women with breast cancer who underwent mastectomy in 2015-2016
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women diagnosed with breast cancer who have undergone mastectomy Participants aged between 18 and 65 years Married or in a marital relationship Psychologically prepared for individual and group therapy and willing to express their emotions and experiences
Exclusion criteria:
Participants must not have severe mental disorders (such as personality disorders, severe depression, or psychotic disorders) Participants must not be currently receiving similar treatments
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Following sample selection, participants will be randomly assigned to the experimental and control groups. In the first stage, after voluntary sample selection, all selected individuals are placed on a list (numbered 1 to 36). In the second stage, among these individuals, using a random method with sealed, opaque, numbered envelopes, participants are divided into experimental and control groups. Each individual randomly selects an envelope and is assigned to the relevant 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
Research Ethics Committee of Islamic Azad University-Najafabad Branch
Street address
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
City
Najafabad
Province
Isfehan
Postal code
8514143131
Approval date
2025-12-11, 1404/09/20
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1404.265

Health conditions studied

1

Description of health condition studied
Women who have undergone mastectomy for breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

2

Description of health condition studied
Body image in women who have undergone mastectomy for breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

3

Description of health condition studied
Resilience in women who have undergone mastectomy for breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

4

Description of health condition studied
Marital satisfaction in women who have undergone mastectomy for breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
The participants’ quality of life will be assessed using standardized questionnaires
Timepoint
Assessments will be conducted before the start of the intervention and after the completion of the treatment sessions (8 to 12 sessions).
Method of measurement
Quality of life before and after the treatment sessions will be measured using the World Health Organization Quality of Life questionnaire (WHOQOL) or the 36-Item Short Form Health Survey (SF-36).

2

Description
Body image will be assessed using questionnaires.
Timepoint
Assessments will be conducted before the start of the intervention and after the completion of the treatment sessions (8 to 12 sessions).
Method of measurement
Instruments such as the Body Image Scale (BIS) or a body image questionnaire for cancer patients will be used.

3

Description
The participants’ level of resilience will be evaluated.
Timepoint
Assessments will be conducted before the start of the intervention and after the completion of the treatment sessions (8 to 12 sessions).
Method of measurement
The Connor-Davidson Resilience Scale (CD-RISC) will be used.

4

Description
Marital satisfaction will be examined.
Timepoint
Assessments will be conducted before the start of the intervention and after the completion of the treatment sessions (8 to 12 sessions).
Method of measurement
To evaluate marital satisfaction, the ENRICH Marital Satisfaction Questionnaire or the Dyadic Adjustment Scale (DAS) will be used.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Participants in this group will receive Cognitive Behavioral Therapy (CBT) over a specified period in 8 to 12 sessions.
Category
Behavior

2

Description
Intervention group: Participants in this group will receive Emotional Schema Therapy over a specified period in 8 to 12 sessions
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Didar Center for Counseling Mental Disorders and Problems
Full name of responsible person
Dr. Gholamreza Talebi
Street address
2nd Floor, Padna Building, No. 44, Amin Alley, Sheyri Bridge, opposite Seyed-al-Shohada Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8135866531
Phone
+98 31 3237 1841
Email
rezatalebi@iau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Iman Sadeghkhani
Street address
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 3086
Email
sadeghkhani@pel.iaun.ac.ir
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
Gholamreza Talebi
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
City
Najafabad
Province
Isfehan
Postal code
9514143131
Phone
+98 913 317 0681
Email
rezatalebi@iau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamreza Talebi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 913 317 0681
Email
rezatalebi@iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasim khademi
Position
Midwifery Educator
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 913 270 4522
Email
Khademi_nasim@yahoo.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
Undecided - It is not yet known if there will be 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
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