The Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on the quality of life, depression and plasma level of cortisol in patients with breast cancer and depressed people
-The effectiveness of mindfulness-based cognitive therapy on depression, quality of life and serum cortisol levels of
people with breast cancer and depressed people
Design
Sixty women with breast cancer and depression were selected by sampling method and they were randomly divided into two groups of 15 people of the experimental and control group
Settings and conduct
Two experimental and control groups of breast cancer patients and depressed people were referred to Omid Hospital and Andisheh Raftar Clinic Clinic in Mashhad until a certain number was screened.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction to participate in research the age range between 18 to 75 Major depressive disorder based on DSM - V Score between 20 to 28 in the second edition of the Beck Depression Scale At least fifth elementary degree Clinical diagnosis of stage 0 to 3 breast cancer based on clinical findings of cytology and physician diagnosis (in the group of people with cancer)
Exit criteria : Men with breast cancer(in the group of people with cancer) Metastasis to other organs of the body including liver, kidney and brain (in the group of people with cancer) Spectrum of schizophrenia and other psychotic disorders, bipolar and related disorders Substance Abuse Disorders Taking drugs that affect the psyche and antidepressants History of participating in a mindfulness program at the time of project implementation Common meditation or yoga exercises during the last three months before entering the study
Intervention groups
The experimental group held therapy sessions for eight 90-minute sessions per week and the control group did not receive any therapy.
Main outcome variables
Quality of life, Cortisol, Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211031052929N1
Registration date:2022-01-10, 1400/10/20
Registration timing:retrospective
Last update:2022-01-10, 1400/10/20
Update count:0
Registration date
2022-01-10, 1400/10/20
Registrant information
Name
Zahra Olyaee
Name of organization / entity
Islamic Azad university of Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 7900
Email address
olyaiez@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-11, 1399/10/22
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
2021-01-11, 1399/10/22
Actual recruitment end date
2021-03-15, 1399/12/25
Trial completion date
empty
Scientific title
The Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on the quality of life, depression and plasma level of cortisol in patients with breast cancer and depressed people
Public title
The Effectiveness of Mindfulness Based Cognitive Therapy on the quality of life, depression and plasma level of cortisol in patients with breast cancer and depressed people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in research
the age range between 18 to 75
Major depressive disorder based on DSM - V
Score between 20 to 28 in the second edition of the Beck Depression Scale
At least fifth elementary degree
Clinical diagnosis of stage 0 to 3 breast cancer based on clinical findings of cytology and physician diagnosis (in the group of people with cancer)
Exclusion criteria:
Men with breast cancer(in the group of people with cancer)
Metastasis to other organs of the body including liver, kidney and brain (in the group of people with cancer)
Spectrum of schizophrenia and other psychotic disorders, bipolar and related disorders
Substance Abuse Disorders
Taking drugs that affect the psyche and antidepressants
Common meditation or yoga exercises during the last three months before entering the study
History of participating in a mindfulness program at the time of project implementation
Age
From 18 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were divided into experimental and control groups based on simple randomization through a table of random numbers in two separate groups of breast cancer patients and depressed individuals.
To use the table of random numbers, first the framework of the statistical community of 30 people in both groups was identified and they were given a two-digit code, respectively. Then the same numbers of digits were selected in the row or column direction. This work continued until 30 items in each group were selected as a sample.
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
Committee on Ethics in Mashhad University of Medical Sciences
Street address
University of research and technology assistance, second floor , Qoreishi building, Daneshgah ST
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.MUMS.REC.1399.447
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Depressed People
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
Primary outcomes
1
Description
Depression score in Beck questionnaire (BDI-II)
Timepoint
Before and after intervention
Method of measurement
Beck depression questionnaire (BDI-II)
2
Description
Quality of life score in the questionnaire SF36
Timepoint
Before and after intervention
Method of measurement
SF36 quality of life questionnaire
3
Description
Serum cortisol levels
Timepoint
Before and after intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: mindfulness-based cognitive therapy : 1- Introduction of the program, structure and goals of the group including familiarity with cancer, depression, familiarity with mindfulness and expression of its logic and presentation of homework for the consolidation of educational materials 2- Education and practice of mindfulness or breathing awareness techniques to increase attention and concentration capacity include 45 minute meditation of body care, ten minutes of breathing along with mindfulness and expressing the logic of each of these techniques, thinking about exercises and accurate sensation of each of them and a three-minute breathing space and expressing its logic 3- Implementation of muscular relaxation technique, practicing conscious movement, keeping thoughts and minds widespread through pursuit of meditative exercises and focusing on conscious breathing and body organs, familiarity with mindfulness (the concept of automatic guide and mind states), familiarity with logic and the goals of this therapy and the practice of mindfulness technique, three-minute breathing 4- 45-minute training and practice, sitting meditation technique and expressing its logic, three-minute breathing exercise and providing simulated exercises for use in times of emotion, understanding negative spontaneous thoughts on depression and cancer, training how the table creates emotional thoughts and training ten-minute breathing along with mindfulness 5- 45-minute body check practicing, training and exercising of discovering reactions to common patterns and applying the potential talents of mindfulness skills to ease the reaction to the present time experiences (control of the wanderer mind), teaching and practicing meditation to accept and evaluate spontaneous thoughts and identification of common cognitive errors in depression 6-45-minute sitting meditation practicing, reviewing patients' problems during home exercise, emotions and anxieties during exercises, teaching techniques to respond to negative spontaneous thoughts, practicing three-minute body check technique and conscious breathing and making awareness the reactions against depression 7- Performing meditation exercises, practicing three-minute breathing, designing a problem during the exercise and discovering their effects on the body and mind, discussing how best continue to move and order created in the last few weeks, a list of pleasurable symptoms and skillfulness and exercising body check 8- Summation and reviewing the program, receiving feedback from group members, applying lessons for dealing with future creation, closing ceremonies, and post-test implementation
Category
Behavior
2
Description
Control group: patients in this group received no treatment.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital of Mashhad
Full name of responsible person
Dr. Kazem Anvari
Street address
Koohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧۶۶١٣٧٧۵
Phone
+98 51 3842 6082
Email
anvarik@mums.ac.ir
2
Recruitment center
Name of recruitment center
Andisheh Raftar Clinic
Full name of responsible person
Javad Bahador Khan
Street address
Sanabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9127674749
Phone
+98 51 3848 2220
Email
bahadorkhan.javad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Shiraz Branch
Full name of responsible person
Dr. Shahram Hesami
Street address
5 km of Sadra City
City
Shiraz
Province
Fars
Postal code
71987-74731
Phone
+98 71 3619 1547
Email
iaushiraz.research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
دانشگاه آزاد اسلامی واحد شیراز
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 of Shiraz
Full name of responsible person
Zahra Olyaee
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
5 Km of Sadra City
City
Shiraz
Province
Fars
Postal code
۷۴۷۳۱ - ۷۱۹۸۷
Phone
07136410041-44
Email
olyaiez@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shiraz
Full name of responsible person
Zahra Olyaee
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
5 km from Sadra City
City
Shiraz
Province
Fars
Postal code
۷۴۷۳۱ - ۷۱۹۸۷
Phone
07136410041-44
Email
olyaiez@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shiraz
Full name of responsible person
Zahra Olyaee
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
5 km of Sadra City
City
Shiraz
Province
Fars
Postal code
۷۴۷۳۱ - ۷۱۹۸۷
Phone
07136410041-44
Email
olyaiez@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