This study aimed to determine the effect of group therapy based on the metacognitive model of detached mindfulness on cognitive performance in patients with multiple sclerosis.The study is a quasi-experimental research which was designed in two groups (intervention and control groups), in three stages of pre-test, post-test, and two months follow-ups. The independent variable of group therapy was based on the metacognitive model of detached mindfulness. It was applied in the interventional group and its effect on the test scores of post-test and follow-up was investigated and compared with the control group. Studied samples were selected among all patients referred to health care centers of Farshchian during 2016.
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 Randomizer site. Each of these groups consisted of 35 individuals. Intervention group during eight week sessions (each session lasting one hour) were treated by group therapy based on the metacognitive model of detached mindfulness. In the first session (before treatment) and eighth session (after treatment) the intervention group patients were asked to perform neuropsychological tests (Pre-test and post-test). It should be noted that the time taken to complete the neuropsychological tests for any member of the intervention and control groups was ranged from 45 minutes to one hour. follow-up session was held after two months in the same place.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112728119N5
Registration date:2016-12-09, 1395/09/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Marzieh Nazaribadie
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 6085
Email address
marzieh.nazari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2016-12-31, 1395/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Group Therapy Based on metacognitive Model of Detached Mindfulness on
Cognitive functions in patients with Multiple sclerosis
Public title
The effect of Group Therapy Based on metacognitive Model of Detached Mindfulness on
Cognitive functions in patients with Multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
Cases diagnosed with multiple sclerosis with EDSS=4; and 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; Absence for more than two sessions.
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
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 Commitee of Hamadan University of Medical Science
Street address
Hamadan
City
Hamadan
Postal code
65167-4-8741
Approval date
2016-11-21, 1395/09/01
Ethics committee reference number
IR.UMSHA.REC.1395.382
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
Cognitive performances
Timepoint
Pre.post and follow
Method of measurement
Inverntory
Secondary outcomes
1
Description
Cognitive performances
Timepoint
Pre, post and follow
Method of measurement
Inventory
Intervention groups
1
Description
The control group will not receive treatment
Category
Behavior
2
Description
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 cognitive performance.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Frschian Hospital
Full name of responsible person
Marzieh Nazaribadie
Street address
Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Hamadan University of Medical Sciences
Full name of responsible person
Sohila Panahi
Street address
Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research,Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Marzieh Nazaribadie
Position
Ph.d
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 3821 6085
Fax
Email
Mnazaribadie@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamamadan University of Medical Sciences
Full name of responsible person
Marzieh Nazaribadie
Position
Ph.d
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 3821 6085
Fax
Email
Mnazaribadie@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Marzieh Nazaribadie
Position
Ph.d
Other areas of specialty/work
Street address
Hamedan
City
Hamedan
Postal code
Phone
+98 81 3821 6085
Fax
Email
Mnazaribadie@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)