Comparison the Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) and Short-Term Axis-based treatment as Therapeutic Supplements with Drug Therapy in Improving the Quality of Life in Multiple Sclerosis(MS) Patients .____________________________________________________________________________
Comparison the Effectiveness of Mindfulness Based Cognitive Therapy and Short-Term Axis-based treatment as Therapeutic Supplements with Drug Therapy in Improving the Quality of Life in Multiple Sclerosis Patients
Design
The present study is a semi-experimental study with pre-test and post-test with control group. The sample size in this study is 60 people, Each group has 20 subjects.
Settings and conduct
The statistical population of patients with multiple sclerosis is a recurrent type that will be referred to Mashhad's treatment centers in the second six months of 1396. The statistical sample will be selected from the statistical community in an accessible manner according to the criteria of entry, and then will be randomly assigned to the control and testing groups
Participants/Inclusion and exclusion criteria
Entry requirements : Diagnosis of Multiple Sclerosis . Age between18_50Year . Minimum Diploma Education . Being in the Phases of Relapsing Remiting .
Conditions of failure to enter : Pass the stage of Relapsing Remiting . Taking psychedelic Drugs .
Intervention groups
A group based on knowledge-based cognitive therapy as well as another experimental group will be treated as a complementary treatment based on the short-term solution-based treatment, but the control group will have drug treatment, and all groups will respond to pre-test and post-test at the same time
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180522039785N1
Registration date:2019-02-02, 1397/11/13
Registration timing:retrospective
Last update:2019-02-02, 1397/11/13
Update count:0
Registration date
2019-02-02, 1397/11/13
Registrant information
Name
hamid afshar shandiz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3727 5753
Email address
mind200011@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2018-11-22, 1397/09/01
Trial completion date
empty
Scientific title
Comparison the Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) and Short-Term Axis-based treatment as Therapeutic Supplements with Drug Therapy in Improving the Quality of Life in Multiple Sclerosis(MS) Patients .____________________________________________________________________________
Public title
Comparison the Effectiveness of Mindfulness Based Cognitive Therapy and Short-Term Axis-based treatment as Therapeutic Supplements with Drug Therapy in Improving the Quality of Life in Multiple Sclerosis Patients .____________________________________________________________________________
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Multiple Sclerosis.
Age between18_50Year.
Minimum Diploma Education.
Being in the Phase of Relapsing Remiting
Exclusion criteria:
Pass the Stage of Relapsing Remiting
Taking Psychedlic Drugs
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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 Committee of Mashhad University of Medical Sciences
Street address
.Mashhad University of Medical Sciences.University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.MUMS.REC.1397.027
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Quality of Life
Timepoint
The quality of life questionnaire is taken before the intervention and after the intervention, pre-test and post-test
Method of measurement
Measurement based on the scale of the questionnaire was used to quantify the quality of life of multiple sclerosis patients in 54 questions
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group receives mindfulness based cognitive therapy,which is for a period of 8 weeks, a weekly session of 2 hours. Intervention includes components such as internal experience, thoughts and mood, and external experiences and interactions with other people.It should be noted that the group is taking cinnovex drug .
Category
Behavior
2
Description
Intervention group: . The second intervention group receives a short-term axis-based treatment, which is for a period of 8 weeks, a weekly session of 2 hours. The intervention includes components such as positive seeing, no labeling, and having a referral capability.It should be noted that the group is taking cinnovex drug .
Category
Behavior
3
Description
Control group: . The third group is a control group that does not receive any intervention. It should be noted that the group is taking cinnovex drug .
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
Hamid afshar shandiz
Street address
Ghaem Hospital in Mashhad.Ahmadabad Street
City
Mshhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
i_rahimian@semnan.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University, Faculty of Psychology and Educational Sciences
Full name of responsible person
Isaac Rahimian Booger
Street address
Mahdish Shahr - Faculty of Psychology and Educational Science
City
semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 3300
Email
i_rahimian@semnan.ac.ir
Web page address
http://psy.semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University, Faculty of Psychology and Educational 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
Semnan University - Faculty of Psychology and Educational Sciences
Full name of responsible person
آHamid Afshar Shandiz
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No426.Tohid18.Tohid street
City
Mashhad
Province
Razavi Khorasan
Postal code
9139786555
Phone
+98 51 3727 5753
Email
mind200011@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Semnan, Faculty of Psychology and Educational Sciences
Full name of responsible person
Hamid Afshar Shandiz
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No426.Tohid18.Tohid Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9139786555
Phone
+98 51 3727 5753
Email
mind200011@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Semnan, Faculty of Psychology and Educational Sciences
Full name of responsible person
Hamid Afshar Shandiz
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No426.Tohid18.Tohid Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9139786555
Phone
+98 51 3727 5753
Email
mind200011@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Related data can share.
When the data will become available and for how long
Starting the access period from 1399
To whom data/document is available
Data will only be available to researchers working in academic institutions.
Under which criteria data/document could be used
Data is provided by researchers for statistical use and statistical analysis.
From where data/document is obtainable
Visit the Central Library of Ferdowsi University of Mashhad to receive data.
What processes are involved for a request to access data/document
Usually, the use of data is done in person and on the Internet.