Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Schema Therapy on Referral thinking, Psychological flexibility, Quality of life and Nausea and Vomiting due to Chemotherapy in Women with Breast Cancer
Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Schema Therapy on Referral thinking, Psychological flexibility, Quality of life and Nausea and Vomiting due to Chemotherapy in Women with Breast Cancer
Design
1. Experimental group 1: pre-test then ACT intervention and then post-test
2. Experimental group 2: pre-test then schema therapy intervention, and then post-test
Settings and conduct
By referring to "Rasool Akram" Hospital in Tehran, 54 women will be selected through available sampling from among the women who are eligible to enter the study. They will be invited to participate in the study. Then, by simple random sampling method, volunteers will be divided into three groups, two intervention groups "one" and "two" and one control group, and the study will enter its therapeutic intervention phase.
Participants/Inclusion and exclusion criteria
Entrance criteria:
1. The person's satisfaction and willingness to participate in the study
2. Getting breast cancer
3. Performing the chemotherapy process
4. having minimum literacy up to 8th education grade
5. Not suffering from severe psychiatric disorders.
Exit criteria
1. The time interval from the definitive diagnosis of the disease is less than two months
2. History of other malignancies
3. Having two consecutive absences from meetings
4. Unwillingness to cooperate
5. Use of complementary therapies
Intervention groups
1. Acceptance and Commitment Therapy (ACT)
2. Schema Therapy
Main outcome variables
Referral thinking, Psychological flexibility, Quality of life and Nausea and Vomiting due to Chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190921044831N3
Registration date:2024-01-17, 1402/10/27
Registration timing:prospective
Last update:2024-01-17, 1402/10/27
Update count:0
Registration date
2024-01-17, 1402/10/27
Registrant information
Name
Farima Minaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 4320
Email address
minaee.farima@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Schema Therapy on Referral thinking, Psychological flexibility, Quality of life and Nausea and Vomiting due to Chemotherapy in Women with Breast Cancer
Public title
Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Schema Therapy on Referral thinking, Psychological flexibility, Quality of life and Nausea and Vomiting due to Chemotherapy in Women with Breast Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The person's satisfaction and willingness to participate in the study.
Having breast cancer
Carrying out the chemotherapy process
Having at least 8th grade education
Not suffering from severe mental disorders
Exclusion criteria:
The time interval from the definitive diagnosis of the disease is less than two months
History of other malignancies
Having two consecutive absences from meetings
Unwillingness to cooperate
Use of complementary therapies
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Fifty-four women will be selected through available sampling among the women who are eligible to enter the study, and after a clear explanation of the objectives of the study and completion of an informed and voluntary written consent form, they will be invited to participate in the study. Then, by simple random sampling method, volunteers will be divided into three groups, two intervention groups "one and two" and one control group, and the study will enter its therapeutic intervention phase.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants do not know about the therapeutic intervention in other groups, and their choice to be in each of the three groups is completely random. The time of meetings is planned so that people in different groups do not meet each other.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical ethics committee of Islamic Azad University of Karaj
Street address
Karaj, the end of Rajaee Shahr, the intersection of Mozen and Esteghlal Blvd., Amirul Mominin University Complex (AS)
City
karaj
Province
Alborz
Postal code
3149968111
Approval date
2023-12-28, 1402/10/07
Ethics committee reference number
IR.IAU.K.REC.1402.130
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C43.5, C44
ICD-10 code description
Malignant neoplasm of breastIncl.:connective tissue of breastExcl.:skin of breast
Primary outcomes
1
Description
Referral thinking: Negative referential thinking is a type of thinking about negative experiences that has three characteristics: repetitiveness, spontaneity, and difficulty in interrupting thoughts.
Timepoint
10 sessions
Method of measurement
Ehring's Referential Thinking Questionnaire
2
Description
Psychological flexibility: The ability to abstract and change cognitive strategies is based on changes in environmental feedback, which requires planning, organized search, and the ability to use environmental feedback to change cognitive patterns.
Timepoint
10 sessions
Method of measurement
Psychological Flexibility Scale: This questionnaire is a 24-question short self-report tool that measures the type of flexibility that is necessary in a person's success to challenge and replace inefficient thoughts with more efficient ones.
3
Description
Quality of life is the perception of each person about his health condition and the level of satisfaction with these conditions. The World Health Organization defines quality of life as a person's understanding of his place in life in the context of the culture and values system in which he lives, which is related to his goals, expectations, standards and concerns.
Timepoint
10 sessions
Method of measurement
WHOQO-BREF ًquestionnaire
4
Description
Chemotherapy-induced nausea and vomiting
Timepoint
10 sessions
Method of measurement
Score from questionnaire and nausea and vomiting index form (INV-2) (Rhodes et al., 1986)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acceptance and Commitment Therapy: ACT
Category
Treatment - Other
2
Description
Intervention group: Schema therapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Rasool Akram hospital
Full name of responsible person
Shahrabano Sepehr Yeganeh
Street address
Tehran-Starkhan-Niyaish St.-Corner of Mansouri St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 936 322 0279
Email
Rasoolhospital@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Afshin Zargar
Street address
Karaj, the end of Rajaee Shahr, the intersection of Mozen and Esteghlal Blvd., Amirul Mominin University Complex
City
Karaj
Province
Tehran
Postal code
3149968111
Phone
+98 26 3425 9571
Email
info@kiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
1
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
Karaj University of Medical Sciences
Full name of responsible person
Shahrzad Sepehr Yeganeh
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Amir al-Momenin University Complex, the intersection of Mozen and Esteghlal Blvd., At the end of Rajaee Shahr.
City
Karaj
Province
Tehran
Postal code
3149968111
Phone
+98 26 3425 9571
Email
yeganehsepehr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Shahrzad Sepehr Yeganeh
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Amir al-Momenin University Complex, the intersection of Mozen and Esteghlal Blvd., At the end of Rajaee Shahr.
City
Karaj
Province
Alborz
Postal code
3149968111
Phone
+98 26 3425 9571
Email
yeganesepehr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Shahrzad Sepehr Yeganeh
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Amir al-Momenin University Complex, the intersection of Mozen and Esteghlal Blvd., At the end of Rajaee Shahr.
City
Karaj
Province
Alborz
Postal code
3149968111
Phone
+98 26 3425 9571
Email
yeganesepehr@yahoo.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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Participant data contains their demographic information without mentioning personal information. The study protocol includes the method of sampling, assigning interventions to groups, and how to implement them. The analysis of details is based on the quantitative statistical analysis of people's scores according to the questionnaires used. The informed consent form is designed based on the rules of conducting clinical trial studies, and its report is published in the form of an original scientific article.
When the data will become available and for how long
Access starts one year after the article is published
To whom data/document is available
Researchers working in reputable scientific and research institutions
Under which criteria data/document could be used
In case of receiving reliable information about conducting a related study and under the condition of referencing and maintaining trustworthiness in the information, in order to help reach a consensus of different results related to the subject.
From where data/document is obtainable
Correspondent author of the manuscript
What processes are involved for a request to access data/document
The person informs the author of the article about his request via email, and after checking the information about the applicant and consulting with other authors, the information is provided with special conditions.