Determining the Effectiveness of Solution-focused Therapy on Mental Health, Life orientation and Meaningfulness in People with Cardiovascular Disease
Design
Controlled clinical trial,with parallel groups,single blind, randomized design، on 80 patients. Randomization is done in a simple way using a table of random numbers.
Settings and conduct
The place of this study is in the Cardiovascular research center of Isfahan University of Medical Sciences.
The study is double blind in which neither the subjects nor the analysts have any information about the individuals in the intervention and control groups, the statistics consultant is not aware of the manner and name of the interventions performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed with coronary heart disease include stable angina pectoris (SA), unstable angina pectoris (USA) and myocardial infarction (MI) and according to angiography, at least one of the coronary arteries is involved in more than 70% or so-called angio-positive; One month has passed since the acute phase of the disease; Maximum 80 years of age; Having at least reading-writing literacy.
Non-inclusion criteria: they are in the acute inflammatory phase; Having acute diseases, autoimmunity, serious psychiatric disorders and in need of immediate treatment
Intervention groups
Intervention group: In this group, Solution-focused Therapy will be performed in 8 90-minute sessions.
Control group: Control group will not receive any treatment during the study period
Main outcome variables
Mental Health; Life orientation; Meaningfulness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200302046668N1
Registration date:2020-08-21, 1399/05/31
Registration timing:retrospective
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Sayed Mostafa Abdellahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3434 2826
Email address
sm.abdellahi@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Solution-focused Therapy on Mental Health, Life orientation and Meaningfulness in People with Cardiovascular Disease
Public title
Effect of Solution-focused Therapy in People with Cardiovascular Disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with coronary heart disease include stable angina pectoris (SA), unstable angina pectoris (USA) and myocardial infarction (MI)
According to angiography, at least one of the coronary arteries is involved more than 70% (angio-positive)
One month has passed since the acute phase of the disease
Maximum age of 80 years old
Having at least reading and writing ability
Ability to hear normally
Personal and conscious satisfaction to participate in the research
Exclusion criteria:
Being in the acute inflammatory phase
Affected by acute diseases, autoimmunity, serious psychiatric disorders and in need of immediate treatment
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random allocation is performed using a table of random numbers. The names of the people are written as codes on paper and are placed in the sealed envelopes so that randomization can be done completely blind.
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluators and statistical consultant will be unaware of the type of intervention.
In this clinical trial the analysts have no information about the individuals in the study and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Scienses
Street address
Isfahan University of Medical Sciences, Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.MUI.MED.REC.1399.093
Health conditions studied
1
Description of health condition studied
Cardiovascular Disease
ICD-10 code
I51.9
ICD-10 code description
Heart disease, unspecified
Primary outcomes
1
Description
Mental Health
Timepoint
Before intervention, after intervention, after 2 months
Method of measurement
General health questionnaire
Secondary outcomes
1
Description
life orientation
Timepoint
Before intervention, after intervention, after2 months
Method of measurement
life orientation test
2
Description
meaning in life
Timepoint
Before intervention, after intervention, after2 months
Method of measurement
meaning in life questionnaire
Intervention groups
1
Description
Intervention group: In this group Solution-focused Therapy is performed for patients. This treatment is a type of psychotherapy that helps patients achieve the thoughts and feelings that affect their behavior.This course of treatment is performed for at least 8 sessions of 90 minutes for these patients, during which the subjects will be taught various solution-oriented techniques for cardiovascular patients.
Category
Other
2
Description
Control group: Control group will not receive any treatment during the study period, However for this group, after the end of the research, the intervention will be done free of charge if it is effective.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Mostafa Abdollahi
Street address
Isfahan University of Medical Sciences, Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8194913596
Phone
+98 31 3434 2826
Email
mostafaabdellahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
researchmanager@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mostafa Abdollahi
Position
psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Isfahan University of Medical sciences, Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174619461
Phone
+98 31 3434 2826
Email
mostafaabdellahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mostafa Abdollahi
Position
psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Isfahan University of Medical sciences, Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174619461
Phone
+98 31 3434 2826
Email
mostafaabdellahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
mostafa abdellahi
Position
psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Isfahan University of Medical sciences, Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174619461
Phone
+98 31 3434 2826
Email
mostafaabdellahi@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
Not applicable
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