Determine effect of emotion regulation training based on Gross model on alexithymia and emotional adjustment in patients with Multiple Sclerosis (MS)
Design
After approving the plan in the university research vice chancellor and receiving the code of ethics from the university research committee, the researcher refers to the clinics affiliated to Shiraz University of Medical Sciences, and after obtaining informed consent from the participants, the demographic information form and questionnaires Will be completed by participants. From the participants who have all the criteria for inclusion in the study, 50 people will be randomly selected and these people will be re-assigned to the intervention and control groups using block randomization method. The intervention group participates in 8 sessions of emotion regulation training based on Gross model. The control group will receive the routine interventions provided in the clinics during this period.
Settings and conduct
The environment of this research is all clinics affiliated to Shiraz University of Medical Sciences, where training sessions will be held in the training halls of the centers.
Participants/Inclusion and exclusion criteria
MS diagnosed by a neurologist who is not in the advanced stage of the disease; ability to read and write; no serious psychiatric illness (psychotic disorders); no use of psychotropic drugs؛ ability to participate in training; not attending training sessions excitement over the past six months.
Intervention groups
The intervention group participated in 8 emotion regulation training sessions based on Gross model. The time of each session is 90 minutes. The control group participates in educational interventions provided by the relevant associations
Main outcome variables
Improve the level of emotional adjustment and adjust the level of emotions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047691N1
Registration date:2020-08-20, 1399/05/30
Registration timing:prospective
Last update:2020-08-20, 1399/05/30
Update count:0
Registration date
2020-08-20, 1399/05/30
Registrant information
Name
Narges Bayatfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3232 1320
Email address
n_bayatfar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Emotion Regulation Training based on Gross model on Alexithymia and Emotional Adjustment in Patients with Multiple Sclerosis (MS)
Public title
Effect of Emotion Regulation Training in MS patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having MS diagnosed by a neurologist who is not in an advanced stage of the disease
Ability to writing and reading
No serious psychiatric illness (psychotic disorders)
Ability to participate in training
Do not use psychedelics
Lack of participation in emotion regulation training sessions during the last six months
Exclusion criteria:
Patients who are in the advanced stage of the disease.
Intolerance of group activities.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Among the participants, those who meet all the criteria for entering the study will be randomly selected 50 people, who will be redistributed using the block randomization method in two groups of intervention and control. Each block size is 4.
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 Shiraz University of Medical Sciences
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Square
City
Shiraz
Province
Fars
Postal code
7333245724
Approval date
2020-05-05, 1399/02/16
Ethics committee reference number
IR.SUMS.REC.1399.236
Health conditions studied
1
Description of health condition studied
Emotion Regulation in Patient with MS
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Improve the level of emotional adjustment and adjust the level of emotions
Timepoint
Start of intervention and one month after the end of the intervention
Method of measurement
Toronto Alexithymia Questionnaire and Rabio Emotional Adjusment Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Interventions include eight Groos-based emotion regulation training sessions, held in groups (two sessions per week). The duration of each session was 90 minutes, with the first 30 minutes including the therapist's speech, the middle 30 minutes devoted to group discussion, and the final 30 minutes including reviewing assignments and debugging.
Category
Lifestyle
2
Description
Control group: During this period, they do not receive emotion regulation intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Shiraz subspecialty clinic
Full name of responsible person
Ladan Zarshenas
Street address
Shiraz- Namazi squre
City
Shiraz
Province
Fars
Postal code
7332456127
Phone
+98 71 3212 7002
Email
zarshenas@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abas Rezaiyan Zade
Street address
Shiraz, Zand St., Central Building of the University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3647 4254
Email
rezaiana@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Narges Bayatfar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
n_bayatfar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ladan Zarshenas
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zarshenas@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Bayatfar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
bayatfarnarges@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