The impact of Expressive Writing therapy on Psychological health of Patients with Vitiligo
Design
The intervention group will be under the expressive writing group. First, patients will complete the GHQ & the DLQI questionnaires. The intervention group is then asked to attend a three-week, 45-minute session with an emotional exposition training content within three weeks.They are asked to write their deepest thoughts and feelings about the experience of vitiligo. In the follow-up, after 12 weeks, the General Health Questionnaire (GHQ) and the Dermatology Life Quality Index (DLQI) are completed by the patients.
Settings and conduct
This study was conducted at the Molecular Dermatology Research Center of the Shiraz Faghihigh Hospital. Patients with vitiligo after completing the consent form will be fully satisfied with the project. the intervention group will undergo psychiatric treatment . First, complete public health and quality of life questionnaires then asked to participate in sessions in three 45-minute sessions with an emotional disclosure content within three weeks. In the follow-up, after 12 weeks of starting the study, patients were contacted by patients in the first 12 weeks after the start of the study.
Participants/Inclusion and exclusion criteria
The inclusion criteria were: (a) age>18 years, (b) the definite diagnosis of vitiligo confirmed by a dermatologist with onset of symptoms at least 6 months prior to the study, (c) the ability to read and write.
The Exit criteria : People who do not want to cooperate & People with cognitive impairment or psychiatric disorder Whose collaboration will limit the study
Intervention groups
The intervention group includes patients with vitiligo receiving treatment group intervention.This criteria does not have a control group.
Main outcome variables
thoughts and feelings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110731007160N7
Registration date:2019-02-17, 1397/11/28
Registration timing:retrospective
Last update:2019-02-17, 1397/11/28
Update count:0
Registration date
2019-02-17, 1397/11/28
Registrant information
Name
Nasrin Hamidizadeh
Name of organization / entity
Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
hamidizade@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2018-03-19, 1396/12/28
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-03-19, 1396/12/28
Trial completion date
2018-03-19, 1396/12/28
Scientific title
Study of the effect of expressive writing on Psychological health in vitiligo patients
Public title
The effect of expressive writing on Psychological health in vitiligo patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria were: (a) age>18 years, (b) the definite diagnosis of vitiligo confirmed by a dermatologist with onset of symptoms at least 6 months prior to the study, (c) the ability to read and write.
Exclusion criteria:
People who do not want to cooperate, People with cognitive impairment or psychiatric disorder whom their collaboration limits the study.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ethics committee , Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran .
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2017-10-27, 1396/08/05
Ethics committee reference number
IR.SUMS.REC.1396.82
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
thoughts and feelings in patients with vitiligo
Timepoint
after 12 week from the start of the study
Method of measurement
General Health Questionnaire (GHQ) و Dermatology Life Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group Therapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Department, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Nasrin Hamidizade
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
n.hamidizade.tahghighat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Nasrin Hamidizade
Position
Manager of MDRC
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
n.hamidizade.tahghighat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Nasrin Hamidizade
Position
Manager of MDRC
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
n.hamidizade.tahghighat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Ranjbar
Position
Staff
Latest degree
Master
Other areas of specialty/work
Others
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
s.ranjbar.mdrc@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data & Result
When the data will become available and for how long
6 month after publish
To whom data/document is available
Reseachers
Under which criteria data/document could be used
By obtaining a license from Vice-Chancellor for Research
From where data/document is obtainable
Vice-Chancellor for Research
What processes are involved for a request to access data/document
Referring to the Research and Technology Dept. of Research Affairs