Determining the Effectiveness of Mindfulness integrated Cognitive Behavior Group Therapy with Mindfulness on Psychological Symptoms in Patients with Multiple Sclerosis
Design
Clinical trial with control ,group Double blind, randomized
Settings and conduct
Shafa hospital in Kerman
Participants/Inclusion and exclusion criteria
The main inclusion criterion:MS-type retardation-related disease with diagnosis of a neurologist
The main inclusion criteria:Cause of other physical illnesses
Intervention groups
10 people receive cognitive-behavioral therapy integrated with mind-awareness, and 10 do not receive any treatment.
Main outcome variables
Depression, anxiety, sleep quality, fatigue, life expectancy
General information
Reason for update
Acronym
MiCBT
IRCT registration information
IRCT registration number:IRCT20160103025817N4
Registration date:2018-03-17, 1396/12/26
Registration timing:prospective
Last update:2018-03-17, 1396/12/26
Update count:0
Registration date
2018-03-17, 1396/12/26
Registrant information
Name
Ali Akbar Parvizi Far
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 330 8692
Email address
aa.parvizif@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study Effectiveness of Mindfulness integrated Cognitive Behavior Group Therapy on psychological symptoms in patients with Multiple Sclerosis
Public title
The Study Effectiveness of Mindfulness integrated Cognitive Behavior Group Therapy on patients with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Incidence of recurrent MS-type MS with diagnosis of neurologist
Confirmation of MS disease based on the results of diagnostic procedures (such as cerebrospinal fluid test, magnetic resonance imaging, MRI)
Awareness of patients from MS in the last year
The age range is between 50 to 18 years old
Conscious and written consent for participation in the research
Having at least a cycle education to complete questionnaires
Exclusion criteria:
affected by other physical illnesses
affected by Psychosis and delusional states
Existence of severe arousal (such as extreme anxiety or anger, impulsivity or uncontrollable restlessness)
Patients who use psychotherapy during research.
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:
20
Randomization (investigator's opinion)
Randomized
Randomization description
By simple randomized simple method, the individuals are assigned to the control and test group using the sealed envelope
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
Kermanshah University of Medical Sciences
Street address
Headquarter, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-02-14, 1396/11/25
Ethics committee reference number
KUMS.REC.1396.616
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
C81.18
ICD-10 code description
Nodular sclerosis classical Hodgkin lymphoma, lymph nodes of multiple sites
Primary outcomes
1
Description
Depression
Timepoint
First study،after the study،Follow up
Method of measurement
Beck Depression Inventory
2
Description
Anxiety
Timepoint
First study, after the study, follow up
Method of measurement
Beck Anxiety Inventory
3
Description
sleep quality
Timepoint
First study, after study, follow up
Method of measurement
Pittsburgh Sleep Quality Index
4
Description
Fatigue
Timepoint
First study, after study, follow up
Method of measurement
Fatigue Severity Scale
5
Description
Life expectancy
Timepoint
First study, after study, follow up
Method of measurement
Miller Life expectancy questionnaire
Secondary outcomes
1
Description
Quality of Life Score
Timepoint
First study, after study, follow up
Method of measurement
Beck Depression Inventory
2
Description
Life expectancy score
Timepoint
First study, after study, follow up
Method of measurement
Miller Life expectancy questionnaire
3
Description
Changing the cost of treatment
Timepoint
First study, after study, follow up
Method of measurement
Miller Life expectancy questionnaire
Intervention groups
1
Description
Intervention group: For eight consecutive two-hour sessions, Mindfulness integrated Cognitive Behavior Group Therapy .
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital in Kerman
Full name of responsible person
DR Akram Farmanbar
Street address
Kosar BLVD.Shafa Hospital in Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5783
Fax
Email
Rsahar2804@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
farid najafi
Street address
Thaleqani hospital.oil field
City
kermanshah
Province
Kermanshah
Postal code
4562388887
Phone
+98 83 3383 4180
Fax
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
دانشگاه علوم پزشکی کرمانشاه
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. AA. parvizifard
Position
phd counseling psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
kermanshah- bagh abrisham
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8239
Fax
Email
Parvizia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. A.A parvizifard
Position
Phd counselling psychology- member of faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8239
Email
Parvizia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. AA parvizifard
Position
موقعیت شغلی phd counseling psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
kermanshah- bagh abrisham
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 38358239083
Email
Parvizia@yahoo.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