Objectives: The aim of this research is evaluation of effectiveness of Mindfulness Based Stress Reduction (MBSR) on psychological symptoms, quality of sleep and quality of life inwomen with Multiple Sclerosis in Ahwaz city. Setting and conduct: Statistical population includes all MS patients that are member of MS association of Ahwaz. Forty women with MS are chosen using available sampling method and they are assigned to two groups randomly (Mindfulness Based Stress Reduction and the control group). All of the groups will receive usual medication too. The Mindfulness Based Stress Reduction group is participated in therapy sessions. Participants of both groups will fill out Depression, Anxiety and Stress Scale (DASS), Petersburg Quality of Sleep (PSQG) and quality of life (SF-36) in three stages of pretest, post test and two month follow up. Major Inclusion and Exclusion criteria: inclusion criteria: being female;having at least 20 years and a maximum of 50years; having multiple sclerosis diagnosis by neurologist; having at least third-level education in guided school; agreement to participate in research according to informed consent and not receiving psychological treatment for at least a month before the study. Exclusion criteria:suffering from a diagnosed psychiatric illness; absence of more than three sessions and MS relapse. Intervention: the Mindfulness Based Stress Reduction group will receive eight weekly treatments. control group do not receive any psychotherapy. Main outcome measures: Depression, Anxiety and Stress, Quality of Sleep and quality of life
General information
Acronym
Mindfulness-based Stress Reduction on Multiple Sclerosis
IRCT registration information
IRCT registration number:IRCT201507087227N5
Registration date:2015-08-08, 1394/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-08, 1394/05/17
Registrant information
Name
Fatemeh Zargar
Name of organization / entity
Tehran Psychiatric Institute, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 8748
Email address
f.zargar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2013-12-01, 1392/09/10
Expected recruitment end date
2014-07-11, 1393/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Mindfulness-based Stress Reduction on Sleep Quality in Women Suffering from Multiple Sclerosis in Ahwaz
Public title
Effectiveness of Mindfulness Based Stress Reduction on psychological Symptom, Sleep and Quality of Life in Women with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged 20 to 50 who are diagnosed with multiple sclerosis by neurologists; at least third-level education in guided school; and absence of any other psychotherapy for three months. Exclusion criteria: suffering from a diagnosed psychiatric illness; absence of more than three sessions and MS relapse.
Age
From 20 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Azad University, Khorasgan branch
Street address
Isfahan, Azad University, Khorasgan branch
City
Isfahan
Postal code
Approval date
2014-09-01, 1393/06/10
Ethics committee reference number
382/821/د/93
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
Sleep Quality
Timepoint
pre-test, post- test and 2 months after starting intervention
Method of measurement
Pittsburgh sleep quality questionnaire
2
Description
psychologial symptoms
Timepoint
pre-test, post- test and 2 months after starting intervention
Method of measurement
Depression, Anxiety and Stress Scale
3
Description
quality of life
Timepoint
pre-test, post- test and 2 months after starting intervention
Method of measurement
quality of life questinnaire (36 items)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mindfulness based stress reduction
Category
Behavior
2
Description
control group: drug therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis Association of Ahwaz
Full name of responsible person
Nastaran Majdinasab
Street address
School of Rehabilitation, Golestan Hospital, Ahwaz
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
investigator
Full name of responsible person
Hoda Kolahkaj
Street address
700, Hossein Abad, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
investigator
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
Isfahan university in medical sciences
Full name of responsible person
Fatemeh Zargar
Position
Ph.D. in clinical psychology, assistant profesor
Other areas of specialty/work
Street address
700, Hossein Abad, Isfahan Isfahan
City
Isfahan
Postal code
۳۹۹۹۸-۸۱۵۵۱
Phone
+98 31 3621 6012
Fax
Email
fatemehzargar@gmail.com
Web page address
http://www.khuisf.ac.ir - http://en.khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university in medical sciences
Full name of responsible person
Fatemeh Zargar
Position
Ph.D. in clinical psychology, assistant profesor
Other areas of specialty/work
Street address
700, Hossein Abad, Isfahan Isfahan
City
Isfahan
Postal code
Phone
+98 31 3621 6012
Fax
Email
fatemehzargar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Khorasgan Azad university
Full name of responsible person
Bentolhoda Kolahkaj
Position
MSc in clinical psychology
Other areas of specialty/work
Street address
94 ,Yousefinejad Ave, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 6388 3569
Fax
Email
hodakolahkaj@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)