Comparison of the effectiveness of acceptance and commitment based therapy and Cognitive - behavioral on anxiety , resilience and life expectancy in Breast Cancer patients
1- Determining the effectiveness of acceptance and commitment therapy (ACT) on death anxiety and resilience and life expectancy in breast cancer patients.
2- Determining the effectiveness of cognitive-behavioral therapy (CBT) on death anxiety, resilience and life expectancy in breast cancer patients.
Design
A clinical trial with a control group, with parallel groups, randomized on 45 patients, was used for randomization from the table of selected numbers.
Settings and conduct
All women aged 25 to 65 with breast cancer who referred to the oncology department of the province hospital in Qazvin and were selected by a simple random method by observing the entry and exit criteria and obtaining informed consent.Treatment (ACT) and (CBT) are held in 8 sessions of 90 minutes once a week for two experimental groups and the control group does not receive treatment intervention.Life expectancy is completed by intervention and control groups.Along with the 3-month follow-up period, it is clear that the therapeutic interventions have maintained their effectiveness.
Participants/Inclusion and exclusion criteria
Entry conditions : Patients with breast cancer, one month has passed since being admitted to the hospital and undergoing chemotherapy and radiation therapy or surgery and related side measures ; Patients must be in the age range of 25 to 65 years old and have the physical ability to attend therapeutic intervention sessions ; Not receiving psychological treatments before group therapy sessions and during group therapy sessions.
Conditions of non-entry : presence of psychological disorders or history of mental illness and hospitalization ; Abuse of drugs and psychiatric drugs
Intervention groups
group of therapy based on acceptance and commitment; group of cognitive-behavioral therapy;The control group does not receive any treatment
Main outcome variables
Death anxiety؛ resilience؛ life expectancy
General information
Reason for update
Acronym
درمان مبتنی بر پذیرش و تعهد ( ACT ) _ درمان شناختی - رفتاری ( CBT )
IRCT registration information
IRCT registration number:IRCT20221113056486N1
Registration date:2023-01-26, 1401/11/06
Registration timing:prospective
Last update:2023-01-26, 1401/11/06
Update count:0
Registration date
2023-01-26, 1401/11/06
Registrant information
Name
Mahdieh Sadeghpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3334 2709
Email address
sadeghpoormahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-30, 1401/11/10
Expected recruitment end date
2023-03-30, 1402/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of acceptance and commitment based therapy and Cognitive - behavioral on anxiety , resilience and life expectancy in Breast Cancer patients
Public title
Improving resilience and life expectancy and reducing death anxiety in cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with breast cancer who have been admitted to the hospital for at least one month after undergoing chemotherapy and radiation therapy or surgery and related side measures.
Patients should be in the age range of 25 to 65 years and have physical ability to attend therapy intervention sessions.
Not receiving cognitive therapy before group therapy sessions or during group therapy sessions.
Exclusion criteria:
Existence of psychological disorders or history of the mental illness and hospitalization.
Abuse of narcotics and psychiatric drugs.
Age
From 25 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this research will be voluntary sampling method. At first, 45 people are randomly selected from the volunteers and given a characteristic code using a random number table and placed inside the envelopes and given to me and given to them. 15 people will be divided into three (acceptance and acceptance treatment group, behavioral treatment group, and control group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The clinical trial is completed with two intervention and control groups, simple randomized, each group of 15 participants.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committees of Islamic Azad University-Roudehen Branch
Street address
Roudehen - University complex of Islamic Azad University
City
Roudehen
Province
Tehran
Postal code
3973188981
Approval date
2022-04-14, 1401/01/25
Ethics committee reference number
IR.IAU.R.REC.1401.003
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.4
ICD-10 code description
Malignant neoplasm of upper-outer quadrant of breast
Primary outcomes
1
Description
Death anxiety
Timepoint
Before and after the implementation of therapeutic interventions and after a period of three months after the therapeutic interventions
Method of measurement
Using Templer's Death Anxiety Questionnaire
2
Description
Resilience
Timepoint
قبل و بعد از اجرای مداخلات درمانی و بعد از گذشت یک دوره سه ماهه بعد از مداخلات درمانی
Method of measurement
پرسشنامه مقیاس تاب آوری کونور و دیودسون
3
Description
life expectancy
Timepoint
Before and after the implementation of therapeutic interventions and after a period of three months after the therapeutic interventions
Method of measurement
Schneider life expectancy questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention and 8 sessions after the intervention
Method of measurement
Quality of life questionnaire
2
Description
depression
Timepoint
Before the intervention and 8 sessions after the intervention
Method of measurement
Beck depression questionnaire
3
Description
anxiety
Timepoint
Before the intervention and 8 sessions after the intervention
Method of measurement
Beck's anxiety questionnaire
Intervention groups
1
Description
Intervention group 1: Treatment based on acceptance and commitment is held in the form of eight ninety-minute group sessions by the researcher once a week.First, death anxiety scores, resilience and life expectancy are determined with the pre-test, and after the implementation of eight therapeutic intervention sessions, a post-test will be taken from the participants to check the effectiveness.The content of treatment intervention sessions based on acceptance and commitment includes the following: First session: introduction, stating the basic concepts of treatment, obtaining informed consent, taking a pre-test and examining people's attitudes about unpleasant thoughts and feelings, acceptance and committed action using metaphors and homework.The second session: reviewing past sessions and practicing contact with the present, paying attention to awareness, wanting instead of avoiding, practicing conscious breathing, practicing wanting instead of avoiding using metaphors. Third session: reviewing past sessions, paying attention to awareness and the mental functions of breaking through using metaphors, homework.The fourth session: review of the previous session, examination of values and committed action, examination of obstacles to conduct behavior consistent with values using metaphors and homework.The fifth session: reviewing the previous session, paying attention to awareness and self as a context, identifying the internal obstacles of a valuable life using metaphor, homework.Sixth session: Examining past sessions, paying attention to awareness, making mistakes, breaking grammatical rules using metaphors, homework.The seventh session: stability of the results and review of exercises of the previous session.Eighth session: summing up the sessions and encouraging the participants to continue the exercises after finishing the sessions and treatment, announcing the end of the sessions and taking the post-test.
Category
Behavior
2
Description
Intervention group 2: cognitive-behavioral therapy in the form of eight ninety-minute group sessions held by the researcher once a week.First, death anxiety scores, resilience and life expectancy are determined with the pre-test, and after the implementation of eight therapeutic intervention sessions, a post-test will be conducted to check the effectiveness of the participants.The content of cognitive-behavioral intervention sessions is as follows : First session: Introducing and explaining the basic concepts of treatment and recipes and taking the pre-test and explaining the physiological, cognitive, behavioral processes, homework.The second session: review of the previous session, getting to know your own thoughts, cognitive distortions, identifying them in your thinking, recognizing resistance to treatment and designing strategies to deal with it and homework.The third session: reviewing the previous session, getting to know the foundations of behavioral consequences, teaching the nature of schemas, the relationship between schemas and spontaneous thoughts, and identifying schemas through the vertical arrow and homework.The fourth session: review of the previous session, work on the vertical arrow and solve the problems that the research participants have in using the vertical arrow in order to identify their negative schema and homework.The fifth session: review of the previous session, getting the participants a clearer picture of how the negative beliefs are connected and compatible with each other, organizing the list of negative beliefs and homework.Sixth session: review of the previous session, acceptance of the fact that beliefs can be changed and it is possible that people can revise their beliefs and homework.Seventh session: review of the previous session, understanding that beliefs are different in terms of usefulness and they can be evaluated based on criteria and homework.Eighth session: reviewing the previous session, learning the application of logical analysis about their beliefs, participants' achievement of the concept of opposing belief and announcing the end of the sessions and taking the post-test.
Category
Behavior
3
Description
Control group 3: general explanation of research objectives and obtaining informed consent and then conducting a pre-test, while the control group does not receive any intervention, and after two months, a post-test is also taken from this group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Mahdieh Sadeghpoor
Street address
Minodar St., Velayat Hospital
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Fax
Email
velayat.h.1390@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Roudehen branch
Full name of responsible person
Pegah Farrokhzad, Mohammad Ebrahim Sarichalo, Hossein Ebrahimi Moghadam, Mahdieh Sadeghpour
Street address
Rodhen - University complex - Islamic Azad University, Roudehen branch
City
Tehran
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5894
Email
info@riau.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, Roudehen 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, Roudehen branch
Full name of responsible person
Pegah Farrokhzad, Mohammad Ebrahim Sarichlou, Hossein Ebrahimi Moghadam, Mahdieh Sadeghpour
Position
Assistant professor, assistant professor, associate professor, PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Roudehen - University complex - Islamic Azad University, Roudhen branch
City
Tehran
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Phone
+98 21 7650 5894
Email
sadeghpoormahdieh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic university - Roudehen Branch
Full name of responsible person
Pegah Farrokhzad, Mohammad Ebrahim Sarichlou, Hossein Ebrahimi Moghadam, Mahdeh Sadeghpour
Position
Assistant professor, assistant professor, associate professor, PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Roudehen - University complex - Islamic Azad University, Roudehen branch
City
Tehran
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Phone
+98 21 7650 5894
Email
sadeghpoormahdieh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic University - Roudehen Branch
Full name of responsible person
Pegah Farrokhzad, Mohammad Ebrahim Sarichlou, Hossein Ebrahimi Moghadam, Mahdia Sadeghpour
Position
Assistant professor, assistant professor, associate professor, PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Roudehen - University complex - Islamic Azad University, Roudehen branch
City
Roudehen
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5894
Email
sadeghpoormahdieh@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