Comparison of the effects of mindfulness-based stress reduction and cognitive behavioral therapy on psychological symptoms, quality of life, and disease activity index of patients with rheumatoid arthritis
The aim of this study is to compare the effects of mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) on psychological symptoms, quality of life, and disease activity index of patients with rheumatoid arthritis.
Design
Randomized clinical trials with control group, community based and pragmatic with parallel groups, non blinded
Settings and conduct
In this study, 75 patients suffering from rheumatoid arthritis will enroll into the study, based on rheumatologist's diagnosis and according to EULAR-ACR criteria, using the convenience sampling method, from the rheumatology department of Imam Ali Clinic in Shahrekord.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Rheumatoid arthritis according to EULAR-ACR criteria and Age over 18 years old.
Exclusion criteria: Patients having History of taking psychiatric medications or history of undergoing psychotherapy, within the past six months and Severe psychiatric illness (psychosis, bipolar disorder, and mental retardation).
Intervention groups
Patients will be divided into three groups. The first intervention group will receive 8 sessions of mindfulness-based stress reduction and second intervention group will receive 8 sessions of cognitive behavioral therapy. The control group will not receive any psychological intervention.
Main outcome variables
Changes in the psychological symptoms; Changes in quality of life; Changes in
disease activity index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110514006480N18
Registration date:2019-01-01, 1397/10/11
Registration timing:registered_while_recruiting
Last update:2019-01-01, 1397/10/11
Update count:0
Registration date
2019-01-01, 1397/10/11
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of mindfulness-based stress reduction and cognitive behavioral therapy on psychological symptoms, quality of life, and disease activity index of patients with rheumatoid arthritis
Public title
Effects of mindfulness-based stress reduction and cognitive behavioral therapy on patients with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Rheumatoid arthritis according to EULAR-ACR criteria
Age over 18 years old
Exclusion criteria:
History of taking psychiatric medications, within the past six months
History of undergoing psychotherapy, within the past six months
Severe psychiatric illness (psychosis, bipolar disorder, and mental retardation)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience Sampling will be done and patients will be randomly divided into three groups using three categories of cards that listed on them the letters A, B and C.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Research Deputy, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2015-08-11, 1394/05/20
Ethics committee reference number
IR.SKUMS.REC.1394.219
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
Changes in the psychological symptoms
Timepoint
Before the intervention, after the intervention and three months after intervention
Method of measurement
General Health Questionnaire (GHQ-28)
2
Description
Quality of life status
Timepoint
Before the intervention, after the intervention and three months after intervention
Method of measurement
SF-36 quality of life questionnaire
3
Description
Changes in disease activity index
Timepoint
Before the intervention, after the intervention and three months after intervention
Method of measurement
Disease Activity Score of 28 Joints(DAS28)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: They will receive 8 sessions of mindfulness-based cognitive behavioral therapy (MBSR).The overall structure of the MBSR program was 2- to 2.5-hour sessions over an eight week period. A structured program of homework including 45 minutes of daily practice, formal exercises, and in some days unofficial mind-boggling exercises to reduce stress was also used.
Category
Lifestyle
2
Description
Intervention group 2: They will receive 8 sessions of cognitive behavioral therapy (CBT). The overall structure of the CBT program was 2- to 2.5-hour sessions over an eight week period. A structured program of homework including 45 minutes of daily practice, formal exercises, and in some days unofficial exercises was also used, and sometimes the individual recorded his/her observations of his/her own daily experiences.
Category
Lifestyle
3
Description
Control group: This group will not receive any psychological treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Clinic of Shahrekord
Full name of responsible person
Doctor Seyed-Kamal Solati
Street address
Shariati Street, Emam Ali Clinic of Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3224 2696
Email
kamal_solati@yahoo.com
Web page address
https://imamaliclinic.skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Kamal Solati
Street address
Kashani Boulevard, Vice Chancellery for Research and Technology, Shahrekord , Medical Sciences University Of
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Web page address
https://research.skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Seyed Kamal Solati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Ayatollah Kashani hospital, Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3334 2414
Fax
Email
kamal_solati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Seyed Kamal Solati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Ayatollah Kashani hospital, Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3334 2414
Fax
Email
kamal_solati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Seyed Kamal Solati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Ayatollah Kashani hospital, Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3334 2414
Fax
Email
kamal_solati@yahoo.com
Web page address
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
Undecided - It is not yet known if there will be 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