Determining the Effectiveness of Group Therapy on Improving Psychological Symptoms and Adjustment of Interpersonal Excitement in Cardiovascular Patients
Design
A clinical trial with a control group with a randomized group
Settings and conduct
8 sessions of 2-hour logotherapy based on the Latin treaty protocol of Marie Diesel's 2015 book
Cardiovascular Rehabilitation Center of Imam Ali Hospital, Kermanshah Cardiovascular Hospital
Participants/Inclusion and exclusion criteria
Cardiovascular Disease Diagnosis for Cardiovascular Diseases
Have at least 8 classes of literacy (Check out tips)
Recurrence and hospitalization in the course of treatment sessions
Absence in more than two sessions of treatment sessions
The patient's unwillingness to continue the treatment process
Intervention groups
Experimental group: they receive 8 psychological therapy sessions. Control group: they receive only medication.
Main outcome variables
Meaning of life Questionnaire score (short form), spiritual well-being questionnaire score, interpersonal emotion regulation questionnaire score, َAttitude to life profile scale, Depression Inventory Score, Anxiety Inventory Score
General information
Reason for update
Acronym
LTEA
IRCT registration information
IRCT registration number:IRCT20190422043347N1
Registration date:2019-06-01, 1398/03/11
Registration timing:registered_while_recruiting
Last update:2019-06-01, 1398/03/11
Update count:0
Registration date
2019-06-01, 1398/03/11
Registrant information
Name
Youkhabeh Mohammadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4618
Email address
youkhabeh.mohammadian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group Logotherapy on improving psychological symptoms and interpersonal emotion regulation in cardiovascular patients
Public title
Effectiveness of group Logotherapy and interpersonal emotion regulation in cardiovascular patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of cardiovascular disease by fellowship
The patient agrees to participate in the research
Age range from 18 to 65 years
Having a minimum grade of 8th grade (third grade)
Exclusion criteria:
Relapse of heart disease
Personality disorders first and second cluster
Cause of asthma and kidney disease
Age
From 18 years old to 65 years old
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
After selecting the samples based on entry criteria, the random sample of the samples is sampled in a sealed envelope. Ultimately, people are assigned to the control and test group.
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
In front of Taleghani Hospital, Naft square
City
Kermanshah
Province
Kermanshah
Postal code
56423-22222
Approval date
2019-04-10, 1398/01/21
Ethics committee reference number
IR.KUMS.REC.1398.047
Health conditions studied
1
Description of health condition studied
Cardiovascular patients
ICD-10 code
Z00-Z99
ICD-10 code description
XXI Factors influencing health status and contact with health services
Primary outcomes
1
Description
Meaning of Life Questionnaire Score
Timepoint
The beginning of the study, between the study, the end of the intervention and the two months after the study
Method of measurement
MEANING IN LIFE QUESTIONNIARE
2
Description
Score of spiritual well-being questionnaire
Timepoint
The beginning of the study, between the study, the end of the intervention and the two months after the study
Method of measurement
spiritual well-being questionnaire
3
Description
The score in the interpersonal emotion regulation questionnaire
Timepoint
The beginning of the study, between the study, the end of the intervention and the two months after the study
Method of measurement
Interpersonal emotion regulation questionnaire
4
Description
Score in Depression Inventory Beck - Second Edition
Timepoint
The beginning of the study, between the study, the end of the intervention and the two months after the study
Method of measurement
Beck Depression Inventory - Second Edition
5
Description
Score in Beck Anxiety Inventory
Timepoint
The beginning of the study, between the study, the end of the intervention and the two months after the study
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental or intervention group receives eight sessions of psychological treatment of group existential and semantic analysis. After the end of the treatment, the subjects will be treated after the procedure and the follow-up period will be two months.
Category
Rehabilitation
2
Description
Control group: This group will be on the waiting list and will be measured at the beginning of the treatment, at the fourth session, at the end of the treatment and in the follow-up period. Once completed, psychological instruction and handwritten booklets will be presented to them.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان تخصصی قلب و عروق امام علی (ع)
Full name of responsible person
یوخابه محمدیان
Street address
Oil Field, Imam Ali Hospital Cardiovascular Hospital
City
Kermanshah
Province
Kermanshah
Postal code
49564-39936
Phone
+98 83 3822 6451
Email
m.ghasemi59110@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Oil Field, facing Imam Ali Hospital
City
Kermanshah
Province
Kermanshah
Postal code
4562388887
Phone
+98 83 3838 4180
Email
m.ghasemi59110@yahoo.com
Grant name
Kermanshah University of Medical Sciences
Grant code / Reference number
دانشگاه علوم پزشکی کرمانشاه
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
Mohammad Ghasemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Medical, Sorkhe lize Ave, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
8614733481
Phone
+98 51 3606 5322
Email
m.ghasemi59110@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
yookhabe mohammadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Medical School, Kermanshah University of Medical Sciences, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671451568
Phone
+98 83 3887 4371
Email
m.ghasemi59110@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Ghasmi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Medical School, Kermanshah University of Medical Sciences, Parastar Blvd
City
kermanshah
Province
Kermanshah
Postal code
8614733491
Phone
+98 51 3606 5322
Email
m.ghasemi59110@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