Investigation and comparison the effect of group therapy based on meta cognitive model of detached mindfulness on therapy on stress, anxiety, depression, fatigue and well - being in patients with Multiple sclerosis
This study aimed to determine the effect of group therapy based on the meta-cognitive model of detached mindfulness on stress, anxiety, depression, fatigue and well - being in patients with multiple sclerosis
Design
Studied samples were selected among all patients referred to health care centers of Farshchian during 2019. First, the subjects were randomly selected from available samples, then in the patient list, 70 patients were randomly selected as a pilot study and were randomly divided into two intervention and control groups using the Randomized site. Each of these groups consisted of 35 individuals
Settings and conduct
Intervention group during eight week sessions (each session lasting one hour) were treated by group therapy based on the meta-cognitive model of detached mindfulness. In the first session (before treatment) and eighth session (after treatment) the intervention group patients were asked to complete questionnaires of study (Pre -test and post-test). Follow-up session was held after two months in the same place.
Participants/Inclusion and exclusion criteria
Inclusion criteria Cases diagnosed with multiple sclerosis Exclusion criteria Mental (psychosis) and physical disorders are required to receive medication or a special diet, such as diabetes; .
Intervention groups
The study is a quasi-experimental research which was designed in two groups (intervention and control groups), in three stages of per-test, post-test, and two months follow-ups. The independent variable of group therapy was based on the meta-cognitive model of detached mindfulness. It was applied in the international group and its effect on the test scores of post-test and follow-up was investigated and compared with the control group
Main outcome variables
stress, anxiety, depression, fatigue and well - being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042666N1
Registration date:2019-04-06, 1398/01/17
Registration timing:registered_while_recruiting
Last update:2019-04-06, 1398/01/17
Update count:0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Mona Arji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 9499
Email address
mona.arji7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison the effect of group therapy based on meta cognitive model of detached mindfulness on therapy on stress, anxiety, depression, fatigue and well - being in patients with Multiple sclerosis
Public title
The effect of Group Therapy Based on meta-cognitive Model of Detached Mindfulness on stress, anxiety, depression, fatigue and well - being in patients with Multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cases diagnosed with multiple sclerosis with EDSS=4
the same medication regimen
those with age ranges between 18 and 45 years
People with diploma or higher education level
Exclusion criteria:
Mental (psychosis) and physical disorders are required to receive medication or a special diet, such as diabetes;
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Studied samples were selected among all patients referred to health care centers of Farshchian during 2019. First, the subjects were randomly selected from available samples, then in the patient list, 70 patients were randomly selected as a pilot study and were randomly divided into two intervention and control groups using the Randomized site. Each of these groups consisted of 35 individuals
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
The Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan
City
Hamadan
Province
Hamadan
Postal code
65167-4-8741
Approval date
2019-02-10, 1397/11/21
Ethics committee reference number
IR.UMSHA.REC.1397.770
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, anxiety, fatigue and well - being and depression
Timepoint
Before and after the intervention and two months after the completion of the intervention
Method of measurement
Inventory
Secondary outcomes
1
Description
Stress, anxiety, fatigue and well - being and depression
Timepoint
Before and after intervention and two months after the intervention
Method of measurement
Inventory
Intervention groups
1
Description
Intervention group: Intervention in interventional group is group therapy based on metacognitive model of detached mindfulness is treatment that is applied on the experimental group and evaluated impact on stress, anxiety, depression, fatigue and well - being.
Category
Behavior
2
Description
Control group: Routine care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Farschian Hospital
Full name of responsible person
Mona Arji
Street address
Hamadan,Farschian Hospital
City
Hamadan
Province
Hamadan
Postal code
6515957133
Phone
+98 81 3824 9499
Email
Mona.arji@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Said Bashirian
Street address
Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
s_Bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mona Arji
Position
Ph.d
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hamedan
City
Hamedan
Province
Hamadan
Postal code
65167-4-8741
Phone
+98 81 3824 9499
Email
mona.arji7@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
mona arji
Position
Ph.d
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jahanpour Street, Etemadiyeh district
City
Hamadan
Province
Hamadan
Postal code
65167-4-8741
Phone
+98 81 3824 9499
Fax
+98 81 3826 9808
Email
mona.arji7@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
mona arji
Position
Ph.d
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hameda
City
Hameda
Province
Hamadan
Postal code
65167-4-8741
Phone
+98 81 3824 9499
Email
mona.arji7@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
Due to the the lack of any data in the outset of the study, we are not able to share with other people.
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