The effectiveness of mindfulness-based stress reduction on fatigue severity, functional disability and emotion dysregulation among patients with multiple sclerosis
The effectiveness of mindfulness-based stress reduction on fatigue severity, functional disability and emotion dysregulation among patients with multiple sclerosis
Design
Randomization (random number table), without placebo control, single arm trial. The sample size of this study is 50 individuals: divided into 2 groups of 25 people.
Settings and conduct
Neyshabour society for support of patients with MS.
Participants/Inclusion and exclusion criteria
50 patients with Multiple Sclerosis referred to Neyshabour society for support of patients with MS.
Inclusion criteria: Age of 20 to 55 years; Diagnosis of MS by a specialist; Having reading and writing skills; Passed at least 12-6 months from the onset of MS disease.
Exclusion criteria: History of using psychiatric drugs; Mental retardation; Mental illness; History of drug abuse.
Intervention groups
Control group: Only for comparison with intervention group, no treatment is performed.
Intervention group: 25 patients referring according to treatment protocol of mindfulness-based stress reduction (MBSR) are treated in 8 sessions. In order to be effective of before and after the intervention, and 2 months after the intervention, the measurements are carried out.
Main outcome variables
Fatigue Severity; Functional inability.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N33
Registration date:2018-07-19, 1397/04/28
Registration timing:registered_while_recruiting
Last update:2018-07-19, 1397/04/28
Update count:0
Registration date
2018-07-19, 1397/04/28
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-13, 1396/11/24
Expected recruitment end date
2018-08-15, 1397/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based stress reduction on fatigue severity, functional disability and emotion dysregulation among patients with multiple sclerosis
Public title
The effectiveness of mindfulness-based stress reduction on fatigue severity, functional disability and emotion dysregulation among patients with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 55 years
Diagnosis of MS by a specialist
Having reading and writing skills
Passed at least 12-6 months from the onset of MS disease
Exclusion criteria:
History of using psychiatric drugs
Mental retardation
Mental illness
History of drug abuse
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 2).
Using Excel software to generate random number tables.
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
Ethics committee of Neyshabur University of Medical Sciences
Street address
Neyshabur University of Medical Sciences, Moalem Square, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318614139
Approval date
2018-04-15, 1397/01/26
Ethics committee reference number
IR.NUMS.REC.1397.4
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
Fatigue Severity
Timepoint
Before and after intervention and 2 months after intervention