Protocol summary

Summary
Objective: The aim of this study is to assess the effect of applying Journaling on Anxiety,Depression and Stress in patients with Multiple Sclerosis. Design: This study is a randomized clinical trial with Interventional and control groups. Setting and Conduct: 80 multiple sclerosis patients coming to Association of multiple Sclerosis patients charity, in Tehran, Iran selected by inclusion criteria and assessed by Depression, Anxiety and Stress Scale (DASS-21) then study intervention was down for intervention group, and after intervention patients of two groups reassessed with DAS-21 and results compared within and between groups. Participants and inclusion and exclusion criteria : 80 multiple sclerosis patients that divided two groups by random allocation. 40 patients for intervention group and 40 patients for control group. Inclusion criteria is diagnosis of Multiple Sclerosis, At least six months history of disease, age between 20 years to 40 years, moderate severity of disease. Exclusion criteria is relapse of disease, Hospitalization, increasing severity of disease to sever mode. Intervention: participants must writes negative feelings and emotions about his/her disease and traumatic event, 30 minutes a day for 30 days (one month). After 1 month patients of two groups reassessed with DASS-21 questionnaire. No intervention was done in the control group.In end of study results was compared within and between groups by paired T-test, chi square, analysis of variance by SPPS software. Main outcome: Level of Depression, Anxiety, Stress.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012071810315N1
Registration date: 2012-12-06, 1391/09/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-06, 1391/09/16
Registrant information
Name
Masoud Fallahi Khoshknab
Name of organization / entity
University of Social Wlfare & Rehabilitation(USWR)
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
fallahi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impacts of Journaling on Anxiety and stress and Depression in Iranian Multiple Sclerosis society patients in Tehran 2010
Public title
Depression, Anxiety and stress in Multiple Sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: "Age: 20-40 years"; " six months history of disease"; " physical and mental ability to move, writing and self care"; "both sex male and female". Exclusion criteria: "Relapse of disease" ; " Hospitalization" ; " Severity of disease" ; " increasing disability to move" ; " writing disability" ; " self care disability".
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Research commitee of University of Social Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjoo Ave, Evin, Tehran, Iran
City
Tehran
Postal code
1681944511
Approval date
2012-11-19, 1391/08/29
Ethics committee reference number
13678.ت.91.801.

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Stress
Timepoint
Before and after intervention
Method of measurement
Depression, Anxiety, Stress Scale (DASS-21)

2

Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Depression, Anxiety, Stress Scale (DASS-21)

Secondary outcomes

1

Description
Depression
Timepoint
Before and after intervention
Method of measurement
Depression, Anxiety and Stress Scale (DASS-21)

Intervention groups

1

Description
Intervention of this study is named " journalism". Journalism is catharsis of emotions and feeling by writing was down in intervention group and any intervention wasn't down in control group.
Category
Behavior

2

Description
The control group did not receive any intervention. only routine treatment continued.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Multiple Sclerosis Society
Full name of responsible person
Dr Shokofeh Alaee MD
Street address
No 35, Shams St, Vesal Shirazi Ave, Engehab Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr Hasan Shakeri
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjoo Ave, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjoo Ave, Evin, Tehran,
Full name of responsible person
Dr Masoud Fallahi Khoshknab PhD
Position
Associate professor/ psychiatric nurse
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjoo Ave, Evin, Tehran, Iran.
City
Tehran
Postal code
1681944511
Phone
+98 21 2218 0036
Fax
+98 21 2218 0036
Email
<fallahi@uswr.ac.ir> < msflir@yahoo.com>
Web page address
http://uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjoo Ave, Evin, Tehran,
Full name of responsible person
Dr Masoud Fallahi Khoshknab
Position
Phd in psychiatric Nursing/ Associated professor
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjoo Ave, Evin, Tehran, Iran.
City
Tehran
Postal code
1681944511
Phone
+98 21 2218 0036
Fax
+98 21 2218 0036
Email
<fallahi@uswr.ac.ir> <msflir@yahoo.com>
Web page address
http://uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjoo Ave, Evin, Tehran,
Full name of responsible person
Dr Masoud Fallahi Khoshknab
Position
PhD in Nursing/ Associated professor
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjoo Ave, Evin, Tehran, Iran.
City
Tehran
Postal code
1681944511
Phone
+98 21 2218 0036
Fax
+98 21 2218 0036
Email
<fallahi@uswr.ac.ir> <msflir@yahoo.com>
Web page address
http://uswr.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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