The effect of training based on Leventhal's self-regulation model on anxiety, stress, depression and illness Perception in women with multiple sclerosis
The aim is to investigate the effect of training based on Leventhal's self-regulation model on anxiety, stress, depression and understanding of the disease in women with multiple sclerosis.
Design
The randomized clinical trial has a parallel intervention and control group, without blinding, on 64 MS patients. Sealedenvelope site and blocks of four were used for randomization.
Settings and conduct
This study will be conducted on women with MS and in the MS Association of Central Province. in a way that includes two control and intervention groups in the form of pre-test and post-test on two occasions. After randomizing the sample size in two groups; In addition to routine training, people in the intervention group will receive self-regulation training based on the Levant model in four to five non-simultaneous sessions and in two to three simultaneous sessions, and in the control group, they will receive only the usual training provided by the clinic's treatment staff. will be
Participants/Inclusion and exclusion criteria
Women aged 18 to 50 with MS who have been diagnosed with MS for at least one year and do not have any other disease or disorder.
Intervention groups
In addition to routine training, people in the intervention group will receive self-regulation training based on the Levant model in four to five non-simultaneous sessions and in two to three simultaneous sessions, and in the control group, they will receive only the usual training provided by the clinic's treatment staff.
Main outcome variables
Stress, anxiety and depression and understanding of the disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220703055351N3
Registration date:2024-02-11, 1402/11/22
Registration timing:prospective
Last update:2024-02-11, 1402/11/22
Update count:0
Registration date
2024-02-11, 1402/11/22
Registrant information
Name
Mahsa Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 1221 9498
Email address
smahsahosseini99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training based on Leventhal's self-regulation model on anxiety, stress, depression and illness Perception in women with multiple sclerosis
Public title
The effect of training based on Leventhal's self-regulation model on anxiety, stress, depression and illness Perception in women with multiple sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Examination of the disease based on the medical record and expert diagnosis
Age between 18-50 years
A history of illness of at least one year
Access to a smartphone and having media literacy (ability to work with a smartphone)
Not being in the relapse stage
Not suffering from any other acute or chronic disease based on self-report and medical record, ability to speak (speech and hearing)
Not having dementia and known mental disorders based on the person's statements and medical record
Patients should not receive other education related to methods of dealing with stress, anxiety and depression
Minimum literacy
Obtaining a score of 0-5.5 on the Extended Disability Status Scale
Not suffering from other autoimmune diseases (psoriasis, myasthenia gravis)
Not suffering from neurological diseases (Parkinson, epilepsy)
Exclusion criteria:
Inability of the patient to continue participating in the research for any reason (accident, death or migration to another city)
Unwillingness to continue cooperation
pregnancy
drug use
Physical limitations
Making specific changes during the study in people's lifestyle or treatment process
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random blocks will be used in order to conceal the randomized allocation of concealment and balance during and after the study. For this purpose, the site sealedenvelope is used. The total sample size, the number of studied groups, and the number of blocks in question (blocks of 4) will be entered on the mentioned site, and its output will be a randomized list including the number of samples separated by the studied groups (control and intervention). Then, the eligible research samples will be selected and based on the priority of reference, each of them will be assigned a code, and by matching that number with the random block allocation list, the patients participating in the research will be assigned to theintervention group and the control 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
Research Ethics Committees of Arak University of Medical Sciences
Street address
Malek St.Arak
City
Arak
Province
Markazi
Postal code
3813944438
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
IR.ARAKMU.REC.1402.199
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Stress is one of the consequences of MS.
Timepoint
Once before the intervention, once immediately after the intervention, four weeks after the intervention
Method of measurement
stress, anxiety and depression questionnaire
2
Description
Anxiety is one of the consequences of MS.
Timepoint
Once before the intervention, once immediately after the intervention, four weeks after the intervention
Method of measurement
stress, anxiety and depression questionnaire
3
Description
Depression is one of the consequences of MS.
Timepoint
Once before the intervention, once immediately after the intervention, four weeks after the intervention
Method of measurement
stress, anxiety and depression questionnaire
4
Description
The understanding of the disease is the influencing factor on how patients deal with their disease.
Timepoint
Once before the intervention, once immediately after the intervention, four weeks after the intervention
Method of measurement
Brief Illness Perception Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine training, people in the intervention group will receive self-regulation training based on the Levantal model in four to five offline sessions through virtual networks as a group and two to three online sessions through Skype as a group. did Each offline session will be multimedia and average 20 minutes, and each online session will be lecture and average 15 minutes. All sessions will be designed based on the two cognitive and emotional dimensions of Leventhal's self-regulation model and will be designed within 5 weeks.
Category
Other
2
Description
Control group: Only the usual training provided by the clinic's treatment staff is received.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers affiliated to Arak University of Medical Sciences
Full name of responsible person
Mahsa Hosseini
Street address
Arak,Arak University of Medical Sciences,Basij Square, Shazand Boulevard
City
Arak
Province
Markazi
Postal code
3813944438
Phone
+98 86 3221 9498
Email
smahsahosseini99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Dawood Hekmat Po
Street address
Arak,Arak University of Medical Sciences,Basij Square, Shazand Boulevard
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahsa Hosseini
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak,Arak University of Medical Sciences,Basij Square, Shazand Boulevard
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
smahsahosseini99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
mahsa hosseini
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak,Arak University of Medical Sciences,Basij Square, Shazand Boulevard
City
Arak
Province
Markazi
Postal code
smahsahosseini99@gma
Phone
+98 86 3221 9498
Email
mahsahoseiny2018@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
mahsa Hosseini
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak,Arak University of Medical Sciences,Basij Square, Shazand Boulevard
City
Arak
Province
Markazi
Postal code
3813944438
Phone
+98 86 3221 9498
Email
smahsahosseini99@gmail.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