The aim of this study is to consider the effect of Mindfulness – based Cognitive Therapy (CT) on psychiatric symptoms and quality of life in patients with SLE.This was an experimental study with randomized clinical trial design, which included 46 patients with SLE who attended Shahrekord's Imam Ali clinic and performed at one year. The inclusion Criteria were Patients with at least 4 American College of Rheumatology criteria; The minimum level of literacy in primary; Participate of volunteered in the project and the exclusion Criteria were: The use psychiatric drugs; Receiving psychological treatment in 6 mounts ago.The patients were randomly chronologically, based on time of entrance into study, assigned to two trial and control groups. Both two groups were taken usual medical care and moreover trial group was taken singly Mindfulness – based Cognitive Therapy in 8 sessions. Participants were assessed at baseline, post-intervention and at six month intervals with General Health Questionnaire (GHQ-28) and Short form 36-items Health Survey Questionnaire (SF-36(V2)).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412018253N3
Registration date:2014-12-11, 1393/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-11, 1393/09/20
Registrant information
Name
Sayed Kamal Solati
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38133338157
Email address
kamal_solati@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2012-08-12, 1391/05/22
Expected recruitment end date
2013-08-13, 1392/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Mindfulness – based Cognitive Therapy on psychology symptoms and quality of life in Systemic Lupus Erythematosus patients
Public title
The effect psychological intervention on quality of life and psychology symptoms lupus patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:Patients with at least 4 American College of Rheumatology criteria ; The minimum level of literacy in primary; Participate of volunteered in the project.
Exclusion Criteria:The use psychiatric drugs;Receiving psychological treatment in 6 mounts ago.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
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
Shahrekord University of Medical Sciences
Street address
Psychiatry ward,Hajar Hospital,Shahrekord ,Iran
City
Shahrekord
Postal code
Approval date
2012-08-12, 1391/05/22
Ethics committee reference number
11-3-91
Health conditions studied
1
Description of health condition studied
Systemic Lupus Erythematosus
ICD-10 code
L93
ICD-10 code description
Lupus Erythematosus
Primary outcomes
1
Description
Quality of Life
Timepoint
Before of intervention,After of intervention,Follow-up
Method of measurement
SF-36 Scale
2
Description
Psychology Symptoms
Timepoint
Before of intervention,After of intervention,Follow-up
Method of measurement
GHQ-28 Scale
Secondary outcomes
1
Description
Not have
Timepoint
Not have
Method of measurement
Not have
Intervention groups
1
Description
Intervention group:Mindfullness based on Cognitive Therapy with drug therapy
Category
Behavior
2
Description
Control group: Drug therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali clinic
Full name of responsible person
Dr.Sayed Kamal Solati
Street address
Psychiatry ward,Hajar Hospital,Shahrekord ,Iran
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Sayed Kamal Solati
Street address
Psychiatry ward,Hajar Hospital,Shahrekord ,Iran
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Sayed Kamal Solati
Position
Ph.D/Associate
Other areas of specialty/work
Street address
Psychiatry ward,Hajar Hospital,Shahrekord ,Iran
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
Email
kamal_solati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Sayed Kamal Solati
Position
Ph.D/Associate
Other areas of specialty/work
Street address
Psychiatry ward,Hajar Hospital,Shahrekord Iran
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
Email
kamal_solati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Sayed Kamal Solati
Position
Ph.D in Psychology
Other areas of specialty/work
Street address
Psychiatry ward,Hajar Hospital,Shahrekord Iran
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
kamal_solati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)