This study will investigate the effectiveness of multimodal therapy on stress in multiple sclerosis. We have two groups and we intervene in experimental group for 12 sessions. Assessments will done in pre, post and follow up. In the end of the therapy, we will compare scores between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102615166N1
Registration date:2014-01-07, 1392/10/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-07, 1392/10/17
Registrant information
Name
Mahmood Bahramkhani
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0045
Email address
m.bahramkhani@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2013-11-01, 1392/08/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of multimodal therapy on perceived stress in multiple sclerosis
Public title
Treatment of stress in MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: affection on MS; acquisition score upper than 23 in GHQ; rule out psychotic and major personality disorder; acqusition high score in Cohen stress questionnaire.
Exclusion criteria: acquisition of the score lower than 23 in general health questionnaire; diagnosis of psychotic and personality disorders; low score in stress questionnaire.
Age
No age limit
Gender
Both
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Unversity of Soicial Welfare and Rehabilitation Sciences
Street address
Kodakyar street, Velenjak
City
Tehran
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
uswr.rec.1392.35
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
Perceived stress
Timepoint
pre and post and 3 months follow-up
Method of measurement
Cohen questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Lazarus multimodal therapy in treatment group. this intervention method based on cognitive behavior therapies that people assess based on seven modality. then by some behavior and cognitive techniques, patients cope with their problems.
Category
Behavior
2
Description
we will not apply any intervention in this group. this group only will apply to compare with intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bolandian Heallth center
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Treatment Adjutancy of Qazvin
Full name of responsible person
Abdollah Keshavarz
Street address
Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Treatment Adjutancy of Qazvin
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
Unversity of Soicial Welfare and Rehabilitation Sciences
Full name of responsible person
Mahmood Bahramkhani
Position
Ph.D condidate
Other areas of specialty/work
Street address
Unversity of Soicial Welfare and Rehabilitation Sciences, Kodakyar street, Velenjak
City
Tehran
Postal code
Phone
+98 21 2288 0045
Fax
Email
m.bahramkhani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Unversity of Soicial Welfare and Rehabilitation Sciences
Full name of responsible person
Mahmood Bahramkhani
Position
Ph.D condidate
Other areas of specialty/work
Street address
Unversity of Soicial Welfare and Rehabilitation Sciences, Kodakyar street, Velenjak
City
Tehran
Postal code
Phone
+98 21 2288 0045
Fax
Email
m.bahramkhani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Unversity of Soicial Welfare and Rehabilitation Sciences
Full name of responsible person
Mahmood Bahramkhani
Position
Ph.D condidate
Other areas of specialty/work
Street address
Unversity of Soicial Welfare and Rehabilitation Sciences, Kodakyar street, Velenjak
City
Tehran
Postal code
Phone
+98 21 2288 0045
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)