Objective: This study aimed to determine the effects of cognitive behavioral group therapy on stress, anxiety and depression in women with multiple sclerosis.Methods: This study is a clinical trial, single blind(about patients in the control group), Two groups and three phases. from all of the women attending the MS clinic of alzahra & Kashani hospitals in Isfahan in 1393, 70 women who meet the inclusion criteria would randomly selected and assigned to two groups : test and control groups.the Test group will attend in 8 weekly sessions of cognitive behavioral therapy, which will carriy out for 90 minutes. the control group will participate in 3 sessions that organized by fellow researcher, and they will discuss and share their experiences . both groups will answer a questionnaire on stress, anxiety and depression (DASS-42) in three stages: before and immediately after the intervention and also one month after the intervention .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012720833N1
Registration date:2015-03-06, 1393/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-06, 1393/12/15
Registrant information
Name
Samira Abbasi
Name of organization / entity
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3228 7822
Email address
s.abbasi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Isfahan University of Medical Sciences
Expected recruitment start date
2014-10-07, 1393/07/15
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group cognitive behavioral therapy on stress, anxiety and depression in women with Multiple Sclerosis
Public title
The effect of cognitive behavioral therapy on stress, anxiety and depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a definite diagnosis of multiple sclerosis by a neurologist and a minimum of six months from the time it is diagnosed; any relapse during the past month; willingness to participate in the study; Previous participate in meetings of complementary medicine such as relaxation therapy, cognitive therapy, and etc until six months before the study ; having mild stress, anxiety and depression based on DASS-42 ; absence of mental and physical disease (acute and chronic) such as heart disease, kidney disease, severe depression, speech or hearing difficulties;any psychotropic drugs at least 3 months before treatment; non of medical staff (doctors, nurses, etc); lack of other complementary treatments such as physical therapy, acupuncture, yoga and psychotherapy sessions during the study; points 5.5- 0 expanded disability status scale (EDSS) Exclusion criteria: 1) lack of desire to continue cooperation in research; lack of attendance at meetings (an absence of more than two sessions) ; dealing with the crisis and the severe stress during the study.
Age
From 19 years old to 50 years old
Gender
Female
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences, School of Nursing and Midwifery
Street address
isfahan, hezarjarib Ave.
City
isfahan
Postal code
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
393513
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
stress
Timepoint
Before the intervention,Immediately after the intervention,One month after the intervention
Method of measurement
DASS-42 questionnaire
2
Description
anexiety
Timepoint
Before the intervention,Immediately after the intervention,One month after the intervention
Method of measurement
DASS-42 questionnaire
3
Description
depression
Timepoint
Before the intervention,Immediately after the intervention,One month after the intervention
Method of measurement
DASS-42 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention in the test group: The treatment program will held eight weekly sessions of cognitive behavioral therapy and each session for 90 minutes.
Category
Treatment - Other
2
Description
Intervention in the control group: the control group will participate in 3 sessions that will organize by fellow researcher, and women will discuss and share their experiences.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Azahra hospital
Full name of responsible person
Dr.Masoud Etemadifar
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
kashani hospital
Full name of responsible person
Dr.Shaigan nejad
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of Isfahan University of Medical Sciences
Full name of responsible person
Saeed Pahlavanzadeh
Street address
Isfahan University Of Medical Sicences Hezarjarib Avenue
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
Saeed Pahlavanzadeh
Position
Msc of Psychiatric Nursing,Nursing and Midwifery Research Care Center, faculty member of psychiatri
Other areas of specialty/work
Street address
Hezarjarib, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2960
Fax
Email
pahlavanzadeh@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of nursing and midwifery, Isfahan university of medical sciences, Isfahan
Full name of responsible person
Samira Abbasi
Position
Msc of psychiatric Nursing
Other areas of specialty/work
Street address
Hezarjarib Avenue,Isfahan
City
Isfahan
Postal code
Phone
+98 31 3228 7822
Fax
Email
s.abbasi@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Samira Abbasi
Position
Msc of Psychiatric Nursing
Other areas of specialty/work
Street address
Isfahan university of medical sciences
City
Isfahan
Postal code
Phone
+98 31 3228 7822
Fax
Email
samiraabbasi6853@gmail.com s.abbasi@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)