Exploration the Risk Factors Related to Lifestyle and Psychological Problems in MS Patients and Development the Intervention Based on it, and the Effect of the Intervention in Self-Management, lifestyle and Psychological Capitals on these Patients
The effect of Cognitive behavioral intervention on health promoting lifestyle, self-management and psychological capital of MS patients.
Design
To examine the effectiveness of intervention, 50 MS patients who volunteered to participate in the study will be included in two groups of control (25 patients) and a test (25) randomly.
Settings and conduct
After the determination of the two groups, the control and test groups are taken from both groups and the test group is then subjected to educational intervention and finally, the post-test is taken from both groups.
Participants/Inclusion and exclusion criteria
Diagnosis of MS by neurologists using MRI Clinical syndrome of the disease for one year
Being between the age of 25 and 45 years
Not attending counseling or simultaneous treatment
Intervention groups
In order to evaluate the effectiveness of intervention, the semi-experimental method with the control group with pre-test and post-test design and follow-up (two months later) will be used.
Main outcome variables
Increasing the health promotion behaviors, self-management and psychological capital
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180508039581N1
Registration date:2019-03-12, 1397/12/21
Registration timing:retrospective
Last update:2019-03-12, 1397/12/21
Update count:0
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
Sajjad Saadat
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 9135
Email address
sajjadsaadat@edu.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-11, 1397/03/21
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploration the Risk Factors Related to Lifestyle and Psychological Problems in MS Patients and Development the Intervention Based on it, and the Effect of the Intervention in Self-Management, lifestyle and Psychological Capitals on these Patients
Public title
The effect of cognitive-behavioral intervention in MS patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of MS by neurologists using MRI
Clinical syndrome of the disease for one year
Being between the age of 25 and 45 years
Exclusion criteria:
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
N/A
Randomization description
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 Guilan University of Medical Sciences
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2018-06-02, 1397/03/12
Ethics committee reference number
IR.GUMS.REC.1397.087
Health conditions studied
1
Description of health condition studied
MS patients
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Participants score in the Walker Health Promoting Lifestyle Profile
Timepoint
Pre-test before intervention, post-test after intervention and follow-up test after two months
Method of measurement
Health-Promoting Lifestyle Profile, Multiple Sclerosis Self-Management Scale-Revised, and Psychological Capital Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Does not receive any intervention.
Category
N/A
2
Description
Intervention group: cognitive behavioral intervention is taught for 8 sessions
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Clinical Research Development Unit
Full name of responsible person
Ali Ashraf
Street address
Parastar Street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2250
Email
crdu.Poursina@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Mehrdad Kalantari
Street address
Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Email
Info@ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Isfahan
Proportion provided by this source
20
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
University of Isfahan
Full name of responsible person
Sajjad Saadat
Position
Phd Student and Psychologist
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Ste 3, Bolv: Shohadaee Gomnam
City
Rasht
Province
Guilan
Postal code
41446431999
Phone
+98 13 3355 9135
Fax
Email
sajjadsaadat69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Sajjad Saadat
Position
Phd Student and Psychologist
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Ste 3, Bolv: Shohadaee Gomnam
City
Rasht
Province
Guilan
Postal code
41446431999
Phone
+98 13 3355 9135
Fax
Email
sajjadsaadat69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Sajjad Saadat
Position
Phd Student and Psychologist
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Ste 3, Bolv: Shohadaee Gomnam
City
Rasht
Province
Guilan
Postal code
41446431999
Phone
+98 13 3355 9135
Fax
Email
sajjadsaadat69@gmail.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
There is no more information
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