Effectiveness of Mindfulness-Based Stress Reduction(MBSR) on illness perception, illness acceptance, difficulties with emotion regulation and cognitive flexibility in Systemic Lupus Erythematosus Patients
the effectiveness of Mindfulness-Based Stress Reduction Therapy on illness perception, illness acceptance, difficulties with emotion regulation, and cognitive flexibility in patients with systemic lupus erythematosus
Design
A randomized clinical trial with a control group on the waiting list, without a blind strain, with a one-month follow-up phase on 20 patients.
Settings and conduct
First, 20 patients with Systemic Lupus Erythematosus will be selected through the purposive sampling of patients referred to the Rheumatology clinic of Al-Zahra Hospital in Isfahan and will be assigned to experimental and control groups. Then patients of both groups will complete the pre-test questionnaires. Patients in the experimental group will be treated with Mindfulness-Based Stress Reduction during weekly sessions over 2 months. The intervention will be provided by a clinical psychologist. During this period, patients in the control group will not receive any intervention. At the end of the intervention for the experimental group, all patients will answer the post-test questionnaires and after one month, the follow-up questionnaires. Upon completion of the project, patients on the waiting list will receive the above intervention.
Participants/Inclusion and exclusion criteria
A minimum of 6 months and a maximum of 3 years have elapsed since the diagnosis of systemic lupus erythematosus
Do not have another physical illness at the same time
No concomitant psychiatric disorders
Do not take any other medicines (except medicines used to treat Lupus)
exclusion criteria : staring Lupus flare
Intervention groups
The groups consist of the experimental group and the control group.
Main outcome variables
illness perception, illness acceptance, difficulties with emotion regulation and cognitive flexibility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201006048952N1
Registration date:2021-03-06, 1399/12/16
Registration timing:prospective
Last update:2021-03-06, 1399/12/16
Update count:0
Registration date
2021-03-06, 1399/12/16
Registrant information
Name
Shirin Irani
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 3860
Email address
shirin_irani@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-05-04, 1400/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Mindfulness-Based Stress Reduction(MBSR) on illness perception, illness acceptance, difficulties with emotion regulation and cognitive flexibility in Systemic Lupus Erythematosus Patients
Public title
Effectiveness of Mindfulness on cognitive and emotional factors in Systemic Lupus Erythematosus Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A minimum of 6 months and a maximum of 3 years have elapsed since the diagnosis of Systemic Lupus Erythematosus
Do not have another physical illness at the same time
No concomitant psychiatric disorders
Do not take any other medicines (except medicines used to treat lupus)
Minimum diploma education
Score less than 14 in the Hospital Anxiety and Depression Scale
Exclusion criteria:
starting lupus flares
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
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 commettee of University of Isfahan
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8134816515
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.UI.REC.1399.094
Health conditions studied
1
Description of health condition studied
Systemic Lupus Erythematosus
ICD-10 code
M32
ICD-10 code description
Systemic lupus erythematosus (SLE)
Primary outcomes
1
Description
Illness perception
Timepoint
Before intervention, after intervention, follow up
Method of measurement
Brief Illness Perception Questionnaire(BIPQ)
2
Description
illness acceptance
Timepoint
Before intervention, after intervention, follow up
Method of measurement
Chronic Illness Acceptance Questionnaire (CIAQ)
3
Description
Difficulties with emotion regulation
Timepoint
Before intervention, after intervention, follow up
Method of measurement
Difficulties in Emotion Regulation Scale
4
Description
Cognitive flexibility
Timepoint
Before intervention, after intervention, follow up
Method of measurement
Cognitive Flexibility Inventory (CFI)
Secondary outcomes
1
Description
clinical characteristics of systemic lupus erythematosus patients
Timepoint
Pretest, Post test and follow up
Method of measurement
Blood test, Clinical examinations, Systemic Lupus Erythematosus Disease Activity Index
Intervention groups
1
Description
The standard mindfulness-based stress reduction treatment (MBSR) protocol will be used to educate patients. This protocol includes 8 sessions of mindfulness-based stress reduction therapy, each of which regularly and separately includes the complete content as follows: Instructional videos for the therapist (theoretical concepts to be taught to patients along with instruction on how to Presenting materials, explanations and examples), therapist training booklets, client training booklets, teaching mindfulness techniques (formal and informal exercises), audio files of techniques and worksheets for clients' homework. In each treatment session, the researcher will provide theoretical basics for patients. In the first to fifth sessions, after presenting the theoretical concepts, a practical mindfulness technique related to the same theoretical concepts will be taught to the clients to better understand the content. And they are asked to do the technique in the meeting. Formal and informal exercise training will then be provided, and patients should complete one round of formal exercise per session. Doing both formal and informal exercises will be part of your homework for next week. The training booklets provided by the treatment protocol for learning and educating clients at home are translated, compiled and compiled for clients under the title of "Home Learning Booklet" for clients and presented to them each session along with homework worksheets. will be. Worksheets include tables where clients should record formal and informal mindfulness exercises and the types of meditations they perform at home on a weekly basis and bring them to the next session.
Category
Behavior
2
Description
Control group: The standard mindfulness-based stress reduction treatment (MBSR) protocol will be used to educate patients. This protocol includes 8 sessions of mindfulness-based stress reduction therapy, each of which regularly and separately includes the complete content as follows: Instructional videos for the therapist (theoretical concepts to be taught to patients along with instruction on how to Presenting materials, explanations and examples), therapist training booklets, client training booklets, teaching mindfulness techniques (formal and informal exercises), audio files of techniques and worksheets for clients' homework. In each treatment session, the researcher will provide theoretical basics for patients. In the first to fifth sessions, after presenting the theoretical concepts, a practical mindfulness technique related to the same theoretical concepts will be taught to the clients to better understand the content. And they are asked to do the technique in the meeting. Formal and informal exercise training will then be provided, and patients should complete one round of formal exercise per session. Doing both formal and informal exercises will be part of your homework for next week. The training booklets provided by the treatment protocol for learning and educating clients at home are translated, compiled and compiled for clients under the title of "Home Learning Booklet" for clients and presented to them each session along with homework worksheets. will be. Worksheets include tables where clients should record formal and informal mindfulness exercises and the types of meditations they perform at home on a weekly basis and bring them to the next session.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Shirin Irani
Street address
Soffeh St.
City
Isfahan
Province
Isfehan
Postal code
8134816515
Phone
+98 31 3233 3860
Email
s.irani@edu.ui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Irani
Street address
Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
8134816515
Phone
+98 31 3233 3860
Email
s.irani@edu.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shirin Irani
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Shirin Irani
Position
Ph.D candidate of Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.139 - Ferdowsi Allay , Sheikhbahaiy St.
City
Isfahan
Province
Isfehan
Postal code
8134816515
Phone
+98 31 3233 3860
Email
s.irani@edu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Shirin Irani
Position
Ph.D candidate of Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 139,Ferdowsi Allay , Sheikhbahaiy St.
City
Isfahan
Province
Isfehan
Postal code
8134816515
Phone
009832333860
Email
s.irani@edu.ui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Shirin Irani
Position
Ph.D candidate of Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sheikhbahaiy St.
City
Isfahan
Province
Isfehan
Postal code
8134816515
Phone
009832333860
Email
s.irani@edu.ui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
This file will not be published because it contains personal and private information of the participants.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some of the documents obtained from this study will be available for the use of researchers interested in this field only after the completion of this trial, maintaining legal conditions, and criteria.
When the data will become available and for how long
accesibility= 12 months after printing results
To whom data/document is available
only academic researchers
Under which criteria data/document could be used
The use of the documents of this clinical trial will be possible only for academic researchers in a limited way, only with the permission of the person in charge of this clinical trial.
From where data/document is obtainable
please send an email to shirin_irani@ymail.com
What processes are involved for a request to access data/document
Send a complete written request to the corresponding person, providing the details and reasons why you need to use the test documentation. Your request will be reviewed and you will be notified of the result.