Compare the effectiveness of ACT (Acceptance and Commitment Therapy) and Mindfulness Based Cognitive - Behavioral Stress Management on the coping with stress, physical symptoms and psychological well being in patients with multiple sclerosis
The goal is to educate patients so that they can use the best possibe ways to deal with life problems, also to improve the individual satisfaction of life quality and ultimately reduces stress and improves physical symptoms in MS patients.
Design
The clinical trial has two intervention groups and a control group based on society and pragmatic with parallel, non blinded, randomized groups, each group consists of 20 people.
Settings and conduct
Scouting and treatment will take place in the Mehregan clinic and MS society during a weekly course that will include 8 sessions, each sessions lasts 120 minutes .
Participants/Inclusion and exclusion criteria
Age range 20 to 40 years ؛
Not having motion impairment ؛
Not having chronic disease ؛
Not having mental illness ؛
Having a high school diploma ؛
Intervention groups
ACT intervention group ( Acceptance and commitment Therapy )
Mindfulness Based Cognitive - Behavioral Stress therapy intervention group
Control group
Main outcome variables
How to deal correctly with problems
Change the styles of coping with stress
Improving the judgment of the person from the degree of quality of the whole life
Reducing stress
Improve physical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180206038644N1
Registration date:2018-06-14, 1397/03/24
Registration timing:retrospective
Last update:2018-06-14, 1397/03/24
Update count:0
Registration date
2018-06-14, 1397/03/24
Registrant information
Name
Sahar Montazeri
Name of organization / entity
Khorasgan azad islamic unervisity
Country
Iran (Islamic Republic of)
Phone
+98 11 3575 0320
Email address
psychologist_68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-09, 1397/02/19
Expected recruitment end date
2018-05-12, 1397/02/22
Actual recruitment start date
2018-05-10, 1397/02/20
Actual recruitment end date
2018-05-15, 1397/02/25
Trial completion date
empty
Scientific title
Compare the effectiveness of ACT (Acceptance and Commitment Therapy) and Mindfulness Based Cognitive - Behavioral Stress Management on the coping with stress, physical symptoms and psychological well being in patients with multiple sclerosis
Public title
Compare the effectiveness of two psychological treatment methods on the symptoms of MS patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not having motion impairment
Not having chronic disease
Not having mental illness
Having a high school diploma
Age range 20 to 40 years
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Purposeful random sampling method
Individual random unit
Randomization tool:random numbers
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
Reasearch Ethics Committe of Chalus
Street address
Islamic Azad University of Chalus ,17th Shahrivar Blvd
City
Chalus
Province
Mazandaran
Postal code
46615397
Approval date
2018-05-08, 1397/02/18
Ethics committee reference number
IR.IAU.CHALUS.REC.1397.5
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Coping styles with stress score in Andler & Parker questionnaire,Physical symptoms score in Thirty-Six questionnaire Quality of Life, Psychological well being score in Ryff questionnaaire
Timepoint
Measurment of coping styles with stress, Physical symptoms and Psychological well being at the begining of the study (before the intervention begins) and two months after intervention and follow up 3 moths after the end of the intervention
Method of measurement
Andler & Parker coping styles with stress questionnaire, Thirty-Six question Quality of Life questionnaire, Ryff psychological well being questionnaaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention is Mindfulness based cognitive- Behavioral stress management, The statistical population of the study consisted of all women with MS in Mazandaran and the sample group included 60 people who were randomly divided into three groups (Mindfulness based cognitive-Behavioral intervention group, Acceptance and Commitment therapy and control group), each one with 20 patients .The patients of experimental group were under Mindfulness Based cognitive - Behavioral Stress therapy.They recieved 8 sessions of therapy every week and each session lasted120 minutes .The purpose of this treatment is to help the authorities to achieve a more valuable life through increased psychological flexibility.
Category
Treatment - Other
2
Description
Intervention group: The second intervention is ACT Therapy ( Acceptance and Commitment therapy), The statistical population of the study consisted of all women with MS in Mazandaran and the sample group included 60 people who were randomly divided into three groups (Mindfulness Integrated Behavior-Cognitive therapy groups, Acceptance and Commitment therapy and control group), each one with 20 patients .The patients of experimental group were under Acceptance and Commitment Therapy .They recieved 8 sessions of therapy every week and each session lasted120 minutes .In this type of treatment instead of changing cognitive, it attemps to increase the psychological relationship of an individual with his thoughts and feelings.
Category
Treatment - Other
3
Description
Control group: There are no intervention such as ( Acceptance and Commitment Therapy and Mindfulness Based Cognitive - Behavioral stress Management )during the study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehregan clinic
Full name of responsible person
Sahar Montazeri
Street address
Mehregan Clinic., Gol Building., Sharifi Blvd.,Shahrbani Square
City
Babolsar
Province
Mazandaran
Postal code
4741741961
Phone
+98 11 3575 0320
Email
psychologist_68@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Of Khorasgan
Full name of responsible person
َAsghar Aghayi Jashoughani
Street address
University Blvd., Arghavanieh., East Gey Street
City
Khorasgan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
aghaeipsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?