The Study of Effectiveness of Mindfulness integrated Cognitive Behavior Therapy on Psychopathology indicators in females with breast cancer: Randomized controlled trial
Determining of Effectiveness of Mindfulness integrated Cognitive Behavior Therapy on Psychopathology indicators in females with breast cancer
Design
A clinical trial with a control group, with parallel, randomized groups, on 30 people , will use the quadratic randomized blocking method for randomization.
Settings and conduct
The sample of this study will be selected from women with breast cancer who refer to Imam Reza Hospital in Kermanshah. To conduct this research, after the approval of the ethics committee of Kermanshah University of Medical Sciences and its registration in the clinical trial system (IRCT), the intervention will be performed in Imam Reza Hospital.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: Breast Cancer disease with diagnosis of a Oncologist.
Main exclusion criteria:Severe mental illnesses include schizophrenia, bipolar I, and severe personality disorders.
Intervention groups
15 participants will receive Mindfulness-integrated cognitive-behavioral therapy (experimental group) and 15 participants will receive psycho-education with the book (control group).
Main outcome variables
Depression, anxiety, Stress, sleep quality, Body image, Sexual function, demoralization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160103025817N6
Registration date:2022-04-06, 1401/01/17
Registration timing:registered_while_recruiting
Last update:2022-04-06, 1401/01/17
Update count:0
Registration date
2022-04-06, 1401/01/17
Registrant information
Name
Ali Akbar Parvizi Far
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 330 8692
Email address
aa.parvizif@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study of Effectiveness of Mindfulness integrated Cognitive Behavior Therapy on Psychopathology indicators in females with breast cancer: Randomized controlled trial
Public title
The Study of Effectiveness of Mindfulness integrated Cognitive Behavior Therapy on Psychopathology indicators in females with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the age group of 30 to 60 years
Ability to read and write and participate in treatment sessions
More than 6 months have passed since the diagnosis of cancer
Having informed consent to participate in research and completing the informed consent form
Non-development of chronic physical diseases such as diabetes and thyroid disorders
Do not attend psychotherapy sessions for six months before starting treatment
Have no other cancers
No problems with hearing and vision
Non-abuse of drugs
Non-development of severe mental illnesses including schizophrenia, bipolar type 1 disorders and severe personality disorders
Exclusion criteria:
Participate in psychotherapy sessions and other support groups at the same time as the research period
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
random quadratic blocking method-The four blocks of intervention (A) and control (B) groups will be defined (AABB, ABAB, ABBA, BBAA, BABA, BAAB) and numbers 1 to 6 will be written on the cards. The cards are then placed in an envelope. Finally, the cards are randomly selected and a random string is created from the sequence of selected cards.
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah, Shahid Beheshti Blvd., Building No. 2, University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-12-12, 1400/09/21
Ethics committee reference number
IR.KUMS.MED.REC.1400.088
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F33.1
ICD-10 code description
Major depressive disorder, recurrent, moderate
2
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention, after the end of the intervention and two months after the end of the intervention
Method of measurement
DASS Depression Inventory
2
Description
anxiety
Timepoint
Before the intervention, after the end of the intervention and two months after the end of the intervention
Method of measurement
DASS Anxiety Inventory
3
Description
stress
Timepoint
Before the intervention, after the end of the intervention and two months after the end of the intervention
Method of measurement
DASS Stress Inventory
4
Description
sleep quality
Timepoint
Before the intervention, after the end of the intervention and two months after the end of the intervention
Method of measurement
Pittsburgh Sleep Quality Index
5
Description
Sexual function
Timepoint
Before the intervention, after the end of the intervention and two months after the end of the intervention
Method of measurement
Rosen Sexual Function Questionnaire
6
Description
Body image
Timepoint
Before the intervention, after the end of the intervention and two months after the end of the intervention
Method of measurement
Hopwood body image Questionnaire
7
Description
Demoralization
Timepoint
Before the intervention, after the end of the intervention and two months after the end of the intervention
Method of measurement
kissane demoralization Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive-behavioral therapy integrated with mindfulness is a regular therapeutic approach that integrates mindfulness meditation with the basic components of cognitive and behavioral techniques and will be performed individually on the intervention group for 8 sessions of 60 minutes per week (for two months). The Curriculum for MiCBT Sessions include: Session 1-Introductory presentation about the sessions and rules, an overview of MiCBT, the concept and principles of mindfulness,mindful breathing. Session 2 -Mindful breathing (continued), an overview of a few MiCBT concepts (such as situation, sensory perception, evaluation, body sensations and reaction), the internal causes of intrusive thoughts and their extinction, part-by-part body scanning. Session 3 -Part-by-part body scanning (continued), explaining about body sensations , informal practice. Session 4 -Body scanning exercises (continued), introducing some CBT components in MiCBT (like exposure methods), encountering unpleasant sensations using Subjective Units of Distress Scale(SUDS) (a kind of form that is used for exposure to target events)through bipolar exposure (imaginary exposure to unpleasant situations). Session 5- review of SUDS, Body scanning exercises (continued).Session 6 -Body scanning exercises (continued), interpersonal skills,assertiveness and role-playing. Session 7-Introducing the concepts of compassion and empathy,loving-kindness meditation.Session 8- Review and evaluation.
Category
Behavior
2
Description
Control group: The control group will be given psychological training along with a book on breast cancer and will be taught about the course and process of cancer and medication. Training will be individual and in one session.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Kermanshah
Full name of responsible person
Dr.Negin Farshchian
Street address
Parastar Blvd, next to the medical school
City
Kermanshah
Province
Kermanshah
Postal code
75333 - 67427
Phone
+98 83 3427 6300
Email
soleymani.psy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Shahid Beheshti Blvd., Building No. 2, University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
4562388887
Phone
+98 83 3838 4185
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. AA. parvizifard
Position
Assistant Professor of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, School of Medicine, Razi Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4617
Email
Parvizia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. A.A parvizifard
Position
Assistant Professor of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, School of Medicine, Zakaria Azi Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4617
Email
Parvizia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. AA parvizifard
Position
Assistant Professor of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, School of Medicine, Zakaria Razi Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4617
Email
Parvizia@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD