The Effectiveness of the Mindful Self-Compassion Therapy on Psychological Symptoms of Cardiovascular Diseases
Design
Based on the inclusion criteria, a list of all patients who met the inclusion criteria is prepared. Then, random grouping with quadruple blocks is used to place individuals in groups (in this study, blinding is not done).
Settings and conduct
First, leaflets containing research information will be given to the participants and written and informed consent will be obtained from them before the implementation of the project. Participants will be assigned to one of the two experimental and control groups, which will initially be from both. The pre - test group is performed and the data is collected, then the experimental group (combining self-awareness compassion therapy with routine cardiovascular therapy) will receive one session per week for eight sessions. The control group will receive a CD and a relaxation book
Participants/Inclusion and exclusion criteria
1. Absence from more than two sessions of treatment sessions.
2. The unwillingness of the subject to continue the treatment process.
Intervention groups
It is a treatment plan that includes therapeutic components such as love, kindness, kind breathing, and informal exercises for daily living, as well as relaxing touching and writing a compassionate letter to oneself.
Main outcome variables
If the treatment of self-compassion is effective, it can be used to increase the quality index due to the effectiveness of the treatment in strengthening and promoting psychological well-being and reducing the psychological problems of these people. It also helps them better manage their illness by reducing the burden of mental health problems in these patients and ultimately affect the outcome of their cardiovascular disease treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038630N5
Registration date:2020-11-18, 1399/08/28
Registration timing:prospective
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Ali Akbar Foroughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 4371
Email address
aliakbar.foroughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of the Mindful Self-Compassion Therapy on Psychological Symptoms of Cardiovascular Diseases
Public title
The Effectiveness of the Mindful Self-Compassion Therapy on Psychological Symptoms of Cardiovascular Diseases
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Based on the diagnosis of a cardiologist with cardiovascular disease
Have a history of hospitalization due to cardiovascular complications
Having a minimum education of 8 literacy classes
No physical illnesses including: kidney failure and asthma according to the medical record
No psychological disorders including substance abuse disorder, psychotic disorders, impulse control disorders, bipolar type 1, post-traumatic stress disorder according to structured clinical interview (SCID-I)
Do not have first and second cluster personality disorders according to structured clinical interview (SCID-I)
Achieve a score higher than the cut-off point in the Beck Anxiety and Depression Test
Do not use supportive therapy sessions and other psychotherapy approaches six months before starting treatment
The desire to participate in self-compassion group compassionate sessions
Exclusion criteria:
Absence from more than two sessions of treatment sessions
The unwillingness of the subject to continue the treatment process
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the inclusion criteria, a list of all patients who met the inclusion criteria is prepared. Then, to place people in groups, random blocking method with quadruple blocks is used
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 University of Medical Sciences
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-10-14, 1399/07/23
Ethics committee reference number
IR.KUMS.REC.1399.805
Health conditions studied
1
Description of health condition studied
Psychological symptoms
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Psychological symptoms of people with cardiovascular disease
Timepoint
Psychological symptoms of people with cardiovascular disease
Method of measurement
Beck Anxiety Scale. Ruminant Response Style Questionnaire. Structured Clinical Interview for Axis I, DSM-IV. Patient Health Questionnaire. Sleep Quality Questionnaire. Multidimensional Anger Scale. Self Compassion Scale (Short Form). Cognitive emotion regulation letter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People who receive mindful self compassion treatment
Category
Behavior
2
Description
Control group: Those who do not receive special treatment but receive a CD and a relaxation book.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.aliakbar foroughi
Street address
kermanshah University of Medical Sciences
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
motaleb.nasri952@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
aliakbar foroughi
Street address
Kermanshah University of Medical Sciences
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
motaleb.naseri95@gmail.com
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
50
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
aliakbar foroughi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah. Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 918 329 6838
Email
mitaleb.naseri95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Akbar Foroughi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah university of medical science., medical school, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 4371
Fax
Email
aliakbar.foroughi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Akbar Foroughi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah university of medical science., medical school, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 4371
Fax
Email
aliakbar.foroughi@kums.ac.ir
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