Effect of Mindfulness-based stress reduction and Cognitive behavior Therapy on Emotional Strategies, Executive function, Activity of disease, quality of life and sleep in Rheumatoid Arthritis Patients
Comparison of the effectiveness of MBSR and CBT on anxiety, stress, depression, chronic fatigue, executive performance, quality of life and sleep, and decreased disease activity in patients with rheumatoid arthritis
Design
This is a randomized study with three groups of MBSR and CBT and the control group. Subsequently, 75 patients with arthritis who have the criteria for entering the thesis will be selected on a sample-based basis. The sampling is based on the goal and Participants were randomly assigned to participate in the intervention and control groups, and all three groups were grouped according to known factors. Subsequently, individuals in the 25-person control, MBSR treatment, and CBT treatment will be replaced. LP
Settings and conduct
The place of doing the research in Kashan Shahid Beheshti Hospital was carried out and the patients were referred to the hospital for first sampling and 75 patients were randomly assigned into three groups (two treatment groups, one control group). This research is a blind clinical trial. Members of each group come to treatment for different days and hours, and the members of the three groups do not meet each other.
Participants/Inclusion and exclusion criteria
A definitive diagnosis of rheumatoid arthritis
Intervention groups
MBSR 8-session treatment once a week
CBT 10-session treatment once a week
Control group: A group whose members receive the same drugs as the rest of the participants.
Main outcome variables
Stress-Depression-Anxiety-Chronic fatigue symptom-Sleep quality-Quality of life-Executive performance-disease activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181128041778N1
Registration date:2019-04-20, 1398/01/31
Registration timing:retrospective
Last update:2019-04-20, 1398/01/31
Update count:0
Registration date
2019-04-20, 1398/01/31
Registrant information
Name
Shafigheh Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5520 3112
Email address
yousefi-sh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Mindfulness-based stress reduction and Cognitive behavior Therapy on Emotional Strategies, Executive function, Activity of disease, quality of life and sleep in Rheumatoid Arthritis Patients
Public title
Effect of Mindfulness-based stress reduction and Cognitive behavior Therapy in Rheumatoid Arthritis Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of RA with arthritis
At least six months have passed since the diagnosis of rheumatoid arthritis
Age of 18 to 60 years
Minimum Cycle Education
Diagnosis of other joints
Exclusion criteria:
There is another joint disease
Drug Addiction
Suicidal ideation or suicidal thoughts
Abuse of alcohol
Absence of more than one session in the treatment of MBSR
There are more than two sessions in the treatment of CBT
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
75 patients are randomly selected for rheumatoid arthritis. Subsequently, they are randomly divided into three groups (MBSR intervention, CBT, control) of 25 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, after the participants are selected, we begin the treatment randomly without knowing what other interventions are in other groups, but the treatment that will be applied to them will be explained. The participants' The treatment is that they do not know that there is another treatment group and another treatment. But after the end of the treatment, we will find out about the rest of the treatments and they will be treated if they are willing to treat them. The right to which group What treatments apply is knowledgeable.
Placebo
Not used
Assignment
Parallel
Other design features
Regarding the classification of patients with rheumatoid arthritis in grade 3, patients will be included in the study of the severity of rheumatoid arthritis due to the active status of the disease and the first and second grades.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Kashan University of Medical Sciences
Street address
Ethics Committee of Kashan University of Medical Sciences, Ghotb Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
3713979671
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.62
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Stress
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
DASS-21
2
Description
Depression
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
DASS-21
3
Description
Anxiety
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
DASS-21
4
Description
Chronic fatigue
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
Chronic fatigue syndrome (CFS)
5
Description
Sleep Quality
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire (PSQI)
6
Description
Quality of life
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
Short Form Health Survey (SF-36)
7
Description
Executive functions
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
Tower of London test
8
Description
Disease activity
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: MBSR : Therapeutic intervention is an 8 session that lasts once a week for 90 minutes, during which participants are taught to communicate at an instant, without judgment, with full attention and awareness to the world inside and outside. This approach comes in line with the CABAT Zein treatment protocol (2013).
Category
Behavior
2
Description
Intervention group: CBT In this research, cognitive-behavioral therapy education is a cognitive-behavioral group method that is provided by the researcher based on therapeutic packages available in this area during 11 sessions of 60 minutes to modify the mental, emotional and behavioral patterns of the members. To be Additionally, being in the group, members can use the feedback from others and decide on the changes they want to do. That is, members can compare their own perceptions of their own with the perceptions of others and then decide what they can do with this information.
Category
Behavior
3
Description
Control group: The control group is the same group that does not receive any treatment except its medication.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Autoimmune Research Center of Beheshti Hospital, Kashan
Full name of responsible person
Dr. Batul Zamani
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences, Kashan, Isfahan, Iran
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
ADRC@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafshe
Street address
Kashan University of Medical Sciences.Ghotb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
88715973474
Phone
+98 31 5554 0021
Email
medicine@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
shafigheh Yousefi
Position
clinical psychology master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 0634
Email
sh.yusefi2012@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
shafigheh yousefi
Position
clinical psychology master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 0634
Email
sh.yusefi2012|@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Shafigheh yousefi
Position
Clinical psychology master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 0634
Email
Sh.yusefi2012@yahoo.com
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