A randomized trial will be performed to determine the effect of written emotional disclosure on psychological distress and quality of life in patients with vitiligo. PATIENTS AND METHODS: 72 vitiligo patients completing medical treatment will be assigned randomly to intervention and control groups. Intervention group will write about their deepest thoughts and feelings during four weeks but control group will take only routine medical treatment. Psychological distress and Quality of life outcomes will be assessed before and 1 month after intervention. Instruments: 1) Dermatologic Quality of life Index: It is a simple 10-question validated questionnaire which has been used in 33 different skin conditions in 32 countries. At present the DLQI is the most frequently used instrument in randomized controlled trials in dermatology. 2) The GHQ is used to detect psychiatric disorder in general patients and out-patients. It assesses the respondent’s current state and asks if that differs from his or her usual state. It is therefore sensitive to short-term psychiatric disorders but not long-standing attributes of the respondent. The four sub-scales, each containing seven items, are as follows: A– somatic symptoms (items 1-7) B– anxiety/insomnia (items 8-14) C– social dysfunction (items 15-21) D– severe depression (items 22-28).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801161788N1
Registration date:2009-08-12, 1388/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-08-12, 1388/05/21
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical sciences and health Services
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of therapeutic writing on quality of life and psychological distress in patients with vitiligo
Public title
Impact of therapeutic writing on quality of life and psychological distress in patients with vitiligo
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Age>18 years, lasting more than 6 month after diagnosis, literacy at least primary school
Exclusion Criteria: psychosis, systemic and chronic illness, no consent to participate in study
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Nursing and Midwifery School, Iran University of Medical Sciences
Street address
Nursing and Midwifery School, Yasemi street, Vanak SQ
City
Tehran
Postal code
Approval date
2009-02-17, 1387/11/29
Ethics committee reference number
1156087
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Psychological distress and quality of life
Timepoint
1 month
Method of measurement
Questionnare
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: education of writing therapy in 60 minute session individualy and writing by pateients daily for 4 weeks + current treatment
Category
Other
2
Description
Control Group: current treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mortazavi
Street address
Vahadat eslami street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Fourogh Rafiee
Street address
Nursing and Midwifey School, Yasemi Street, Vanak Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran university of Medical Sciences, Nursing and Midwifery School
Full name of responsible person
Leili Borimnejad
Position
Assistant professor
Other areas of specialty/work
Street address
Nursing and Midwifery School, Yasemi Street, Vanak SQ
City
Tehran
Postal code
Phone
+98 21 8247 1711
Fax
Email
borimnej@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran university of Medical Sciences
Full name of responsible person
Leili Borimnejad
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Midwifery School, Yasemi Street, Vanak SQ
City
Tehran
Postal code
Phone
+98 21 8247 1711
Fax
Email
borimnej@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)