The general purpose of this study is to evaluate the effectiveness of treatment focused on self-critical compassion, internalized shame, resilience, and quality of life in patients with vitiligo.
Design
The clinical trial has a control group and is studied on 40 patients who are assigned to two groups based on a random table.
Settings and conduct
A quasi-experimental clinical trial is performed in Razi Hospital on 40 patients who were randomly selected and randomly assigned to a group of 20 people and a double-blinding method is used in which patients and researchers do not know how to allocate patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of the disease based on clinical evidence such as the appearance of skin lesions and, if necessary, skin biopsy and confirmation of vitiligo by a dermatologist
- Age range 20 to 45 years
Having at least a basic education
At least six months of history of the disease
- Completing the informed consent form based on voluntary participation in the study and not receiving psychological services outside the treatment session
Exclusion criteria: Having diagnostic criteria for obvious psychiatric disorders based on clinical interview
Addiction or alcohol consumption
History of being hospitalized in psychiatric wards
- Consumption of psychiatric drugs
Participate in compassion-focused treatment programs over the past six months
Intervention groups
The group receives a therapy package based on the principles, foundations, and techniques of compassion-focused therapy in 8 two-hour sessions based on Gilbert's book on compassion-focused therapy.
Main outcome variables
Self-critical, internalized shame, resilience and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201103049252N1
Registration date:2020-11-17, 1399/08/27
Registration timing:prospective
Last update:2020-11-17, 1399/08/27
Update count:0
Registration date
2020-11-17, 1399/08/27
Registrant information
Name
Abbas Masjediarani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
a.masjediarani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-01-12, 1400/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Compassion-Focused Therapy (CFT) on Self Criticism, Internalized Shame, Resilience and Quality of Life in Patients with Vitiligo
Public title
The Effect of Compassion-Focused Therapy (CFT) in Patients with Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Diagnosis of the disease based on clinical evidence such as the appearance of skin lesions and, if necessary, by skin sampling and confirmation of vitiligo by a dermatologist 2. Age range 20 to 45 years 3. Having at least primary education 4. At least six months of disease history 5. Completing the informed consent form based on voluntary participation in the study and not receiving psychological services outside the treatment session
Exclusion criteria:
1. Have diagnostic criteria for obvious psychiatric disorders based on clinical interview 2. Addiction or alcohol consumption 3. History of being hospitalized in psychiatric wards 4. Consumption of psychiatric drugs 5. Participate in treatment programs related to compassion-focused treatment during the past six months
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The sample is selected as available, after identifying 40 samples based on the inclusion criteria that have referred to Razi Hospital, using a simple randomization method individually using a random number table of 20 people for the treatment group and 20 people for the group Selected and specialized controls are given.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, the purpose of the study is first explained to the patients and they participate in the study if they are satisfied, but the participants are not given information about how to be in the group, and even the researchers who are doing the patient evaluation work. They will not have any information about assigning the subjects to the information group.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University Medical Sciences
Street address
Evin, Daneshjoo Blvd., Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
3311123322
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.SBMU.MSP.REC.1399.343
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Self-critical
Timepoint
The variable is measured before performing the protocol. After performing the protocol, the variable is measured and then measured again three weeks later
Method of measurement
Thomson and Zarov self-critical levels scale
2
Description
Internalized shame
Timepoint
The variable is measured before performing the protocol. After performing the protocol, the variable is measured and then measured again three weeks later
Method of measurement
Internalized Shame Scale
3
Description
Resilience
Timepoint
The variable is measured before performing the protocol. After performing the protocol, the variable is measured and then measured again three weeks later
Method of measurement
Connor & Davidson Resilience Scale
4
Description
Quality of Life
Timepoint
The variable is measured before performing the protocol. After performing the protocol, the variable is measured and then measured again three weeks later
Method of measurement
World Health Organization Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The treatment package was based on the principles, foundations and techniques of compassion-focused treatment in 8 two-hour sessions based on the book of compassion-focused treatment written by Gilbert and will be performed for the intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
razi hospital
Full name of responsible person
abbas masjedi arani
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
a.masjediarani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Zayayi
Street address
Tehran - Shahid Chamran Highway - Yemen Street - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences Postal Code:
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9951
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Masjedi Arani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
a.masjediarani@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Masjedi Arani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
a.masjediarani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Masjedi Arani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
a.masjediarani@sbmu.ir
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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After the intervention and the results of the research, the results are shared in general without mentioning the names of the people.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All students and professors of psychology
Under which criteria data/document could be used
Can be used for review and meta-analysis research.
From where data/document is obtainable
Refer to Shahid Beheshti University of Medical Sciences and then to Dr. Masjedi Arani.
What processes are involved for a request to access data/document
After collecting the sample and then analyzing the data and then publishing the article, people can access the results through Google Scholar.