Assess the effect of spirituality educational program on the anxiety and depression in patients with multiple sclerosis
Design
This study is a randomized controlled trial that is designed before and after with control group.
Sixty eligible patients will be recruited to the study. They will be randomly allocated to an experimental and a control group using a table of random numbers
Settings and conduct
In the experimental group, patients will receive spirituality educations in eight ninety-minute weekly sessions in the Multiple Sclerosis Association, and in the control group, participants will receive routine illness education. anxiety and depression will be assessed one month after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definite diagnosis of multiple sclerosis(MS) for at least one year; having educational level of guidance school or higher; Having the minimum age of 20 and maximum of 50; Obtain score 16 to 28 from Beck Depression Inventory and 12-26 from Beck Anxiety Inventory;
Exclusion criteria: having a history of psychotic disorders, dementia, and delirium; having history of using psychiatric medications in the past month; drug addiction; taking psychological therapies
Intervention groups
In the experimental group, patients will receive spirituality education in eight ninety-minute weekly sessions in the multiple sclerosis association, and in the control group, participants will receive routine education
Main outcome variables
Depression and Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170404033212N2
Registration date:2018-02-16, 1396/11/27
Registration timing:registered_while_recruiting
Last update:2018-02-16, 1396/11/27
Update count:0
Registration date
2018-02-16, 1396/11/27
Registrant information
Name
Siamak Amiri
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 4829
Email address
amiri.s@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Alborz University of Medical Sciences
Expected recruitment start date
2018-02-01, 1396/11/12
Expected recruitment end date
2018-05-01, 1397/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Spirituality Education Program on Depression and Anxiety in Patients with Multiple Sclerosis
Public title
Effect of Spirituality Education Program on Depression and Anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of Multiple Sclerosis based on Patients’ Medical Records
Having at least one year of history of suffering from multiple sclerosis
Having educational level of guidance school or higher
Having a minimum age of 20 and maximum of 50
Obtain score 16 to 28 from Beck Depression Inventory (mild to moderate depression)
Obtain 12-26 Beck Anxiety Inventory (mild to moderate anxiety)
Exclusion criteria:
History of Psychotic Disorders, Dementia, or Delirium (based on their medical records)
Taking psychiatric drugs (Anti-anxiety, Antidepressant, mood stabilizer) in the past month
Having psychological therapies
Drug Addiction (based on medical records and patients' self-reports)
Age
From 20 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)
Randomized
Randomization description
Table of random numbers
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 Alborz University of Medical Sciences,
Street address
North Taleghani st., shahrak edari
City
Karaj
Province
Alborz
Postal code
3193914714
Approval date
2015-08-26, 1394/06/04
Ethics committee reference number
abzums.rec.1394.39
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
Depression score in the Beck Depression Inventory
Timepoint
before and after 30 days
Method of measurement
Beck Depression Inventory
2
Description
Anxiety score in the Beck Anxiety Inventory
Timepoint
Before and After 30 days
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group, patients will receive spirituality education in eight ninety-minute weekly sessions
Category
Prevention
2
Description
Patients in the control group will receive routine multiple sclerosis-related educations
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz MS Association
Full name of responsible person
Shahrokh Abadian
Street address
Azadegan sq , Karaj
City
Karaj
Province
Alborz
Postal code
3193914714
Phone
+98 26 3256 7670
Email
info@msalborz.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Noori Sepehr
Street address
North Taleghani, Shahrak Edari
City
Karaj
Province
Alborz
Postal code
3146883411
Phone
+98 26 3255 8924
Email
abzums.research@gmail.com
Web page address
http://www.abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Siamak Amiri
Position
Faculty member instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
First Golestan St, Eshteraki Ave, Nursing and Midwifery School
City
Karaj
Province
Alborz
Postal code
3146883411
Phone
+98 26 3433 4829
Fax
Email
siamakamiri16@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Siamak Amiri
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
ّFirst Golestan St, Eshteraki Ave, Nursing and Midwifery School
City
Karaj
Province
Alborz
Postal code
3193914951
Phone
+98 26 3433 4829
Fax
Email
siamakamiri16@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Siamak Amiri
Position
Instructor/ College Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
ّFirst Golestan St, Eshteraki Ave, Nursing and Midwifery School
City
Karaj
Province
Alborz
Postal code
3193914951
Phone
+98 26 3433 4829
Fax
Email
siamakamiri16@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available