The aim of this study was to control stress and negative emotions in heart patients
Design
The clinical trial has an experimental group and a control group. People who meet the criteria for entering the research will be given a number, for example, if 50 people have the criteria to enter the research, they will be given a number from 1 to 50, respectively, then at least 15 of these numbers will be drawn by lot. It is considered for the experimental group and 15 people for the control group.
Settings and conduct
1. Collecting samples from Dr. Heshmat Rasht Specialized Heart Hospital
2. Interview of samples and check Inclusion criteria
3. Random allocation of samples in experimental and control groups
EFT.4 Only the experimental group performs a 90-minute weekly session for 8 weeks
5. Blinding is not done
Participants/Inclusion and exclusion criteria
Inclusion criteria: cardiovascular disease, age range 20 to 55 years, relative stability of physical and mental health, high score on perceived stress and alexithymia ., Exclusion: other mental or physical illness, acute heart disease
Intervention groups
Emotion-focused therapy on the experimental group in the form of training on emotional awareness, symbolization and processing and conversion of emotion, in the form of therapeutic techniques. The control group does not receive training in this field, but like the experimental group, they participate in pre-test and post-test and answer the questionnaires.
Main outcome variables
alexithymia and perceived stress.
General information
Reason for update
Acronym
EFT
IRCT registration information
IRCT registration number:IRCT20200808048335N1
Registration date:2020-10-01, 1399/07/10
Registration timing:prospective
Last update:2020-10-01, 1399/07/10
Update count:0
Registration date
2020-10-01, 1399/07/10
Registrant information
Name
Maryam Aghelmasjedi
Name of organization / entity
Rahman Higher Education Institute
Country
Iran (Islamic Republic of)
Phone
+98 11 5423 5160
Email address
aghelmasjedi@rahman.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Emotion-Focused Therapy (EFT) on Perceived Stress and alexithymia in Cardiovascular Patients
Public title
The effect of emotion in cardiac Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
They have Cardiovascular disease
They are relatively stable in terms of Physical and Mental health
They have high Perceived Stress
They have high Alexithymia
Exclusion criteria:
They have a Mental or other Physical Illness
They have acute and severe symptoms of heart disease
They are under 20 years old or over 55 years old
People who are undergoing other psychological treatment at the same time
Age
From 20 years old to 55 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
The method of simple randomization and its unit is individual. People who have the criteria to enter the research are assigned a number. For example, if 50 people have the criteria to enter the research, they are assigned a number from 1 to 50, respectively. The numbers, by lot, are at least 15 for the experimental group and 15 for the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rasht University of Medical Sciences
Street address
Namjoo Ave., Shahid Siadati St., Rasht., Technology & Research Vice-chancellor of University
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2020-07-01, 1399/04/11
Ethics committee reference number
IR.GUMS.REC.1399.157
Health conditions studied
1
Description of health condition studied
Topics covered include stress, alexithymia, and emotion-focused therapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
1. alexithymia Score in the Toronto alexithymia Questionnaire
Timepoint
Measurement of alexithymia at the beginning of the study (before the intervention) and 60 days after the start of treatment (EFT)
Method of measurement
Toronto alexithymia Questionnaire
2
Description
2. Perceived Stress Score in the Perceptual Stress Questionnaire Cohen et al.
Timepoint
Measurement of perceived stress at the beginning of the study (before the intervention) and 60 days after the start of treatment (EFT)
Method of measurement
Perceived Stress Questionnaire by Cohen et al
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Educating patients during 8 training sessions, 90 minutes and one session per week. The content of each session is stated separately. 1.Communication and Commitment in Treatment, Explaining Heart Disease, Causing and Maintaining Factors, Risk Factors, Describing Group Rules, Discussing Confidentiality, Goals, Type of Emotion Focused Therapy Conceptualization, Assessment of Subjects Based on Ability to Focus On internal experiences 2. Identifying a faulty interactive cycle, identifying conflicting, dualistic, and critical feelings about yourself and important influential people in life 3. Identify basic emotions and express emotion, teach the naming of emotions in the present, discuss the four main emotions and their needs 4. Creating usually unpleasant emotional experiences in communication and family contexts and challenging them, placing the subjects in a two-chair dialogue position to identify the initial hidden emotion and debate between the empiricist and the self-critic 5. The use of relaxation techniques, speech, and self-criticism can be calmed down and the subject's experience of helplessness reduced. Put subjects in an empty chair to talk to influential people in their lives 6. Strengthening positive emotions through the process of forgiveness and self-criticism and its positive effects on patients' cardiac function and increasing awareness of the consequences of delaying the process of forgiveness. 7. Expressing your own values and how to live with them and pointing to emotional and emotional needs and ways to meet those needs in line with values (for example maintaining health as a value) 8.Review the skills offered and reinforce the changes made during treatment. Highlighting the differences between current and old interactions and summarizing points raised in previous sessions
Category
Behavior
2
Description
Control group: In this study, the control group will not receive any treatment training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Heshmat Hospital
Full name of responsible person
Jalal Kheirkhah
Street address
Bayani St., Dr. Heshmat Heart Hospital
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 2058
Fax
+98 13 3333 2058
Email
aghelmasjedi@rahman.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Namjoo Ave., Shahid Siadati St., Rasht., Technology & Research Vice- chancellor of University
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 2058
Fax
+98 13 3333 2058
Email
aghelmasjedi@rahman.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rahman Institute of Higher Education
Full name of responsible person
Maryam Aghelmasjedi
Position
Invited faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Next to the gas office., Imam Reza Blvd. Basij crossroad
City
Ramsar
Province
Mazandaran
Postal code
46916-84144
Phone
+98 11 5523 0511
Email
aghelmasjedi@rahman.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rahman Institute of Higher Education
Full name of responsible person
Maryam Aghelmasjedi
Position
Invited faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Next to the gas office., Imam Reza Blvd. Basij crossroad
City
Ramsar
Province
Mazandaran
Postal code
46916-84144
Phone
+98 11 5523 0511
Fax
+98 11 5523 0515
Email
aghelmasjedi@rahman.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rahman Institute of Higher Education
Full name of responsible person
Maryam Aghelmasjedi
Position
Invited faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Next to the gas office., Imam Reza Blvd. Basij crossroad
City
Ramsar
Province
Mazandaran
Postal code
46916-84144
Phone
+98 11 5523 0511
Fax
+98 11 5523 0515
Email
aghelmasjedi@rahman.ac.ir
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