The effectiveness of online Mindfulness-Based Stress Reduction (MBSR) intervention on physical, psychological and cognitive health indicators in adolescents with type 1diabetes in Isfahan
Investigating the effect of online mindfulness-based stress reduction intervention on hemoglobin A1C, diabetes distress, psychological well-being and attention bias in adolescents with type 1 diabetes.
Design
Clinical trial has two experimental and control groups, with parallel groups, randomized with Excel software
Settings and conduct
The sample group will be 50 adolescents with type 1 diabetes who have a file in the Endocrine and Metabolism Research Center of Isfahan, located in the Hazrat Sedigheh Tahereh Research and Training Center. And will be randomly assigned to the experimental and control groups. After the pre-test, all members of the experimental group will receive the online intervention in eight sessions (one session per week for two hours) by the Mindfulness-Based Stress Reduction intervention (MBSR) instructor. At the end of the intervention sessions, the post-test will be performed on the experimental and control groups. Also, in order to observe ethical considerations, after the post-test, the MBSR intervention will be performed on the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adolescents 15 to 25 years old with type 1 diabetes who have had diabetes for at least a year and have a hemoglobin A1C level above 7%.
exclusion criteria: having severe psychiatric illnesses; Use of drugs or psychotropic drugs; Physical and mental disabilities; Being pregnant; Having other autoimmune diseases in addition to diabetes.
Intervention groups
Intervention group: mindfulness-based stress reduction intervention will be conducted online in 8 weekly sessions (two hours each session). Homework will also be provided daily.
Control group: The control group will not receive any intervention.
The effectiveness of online Mindfulness-Based Stress Reduction (MBSR) intervention on physical, psychological and cognitive health indicators in adolescents with type 1diabetes in Isfahan
Public title
The effect of mindfulness on diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents with type 1 diabetes who have had diabetes for more than a year.
Adolescents with type 1 diabetes who have a hemoglobin A1C above 7%.
Adolescents with type 1 diabetes who have the ability to work with e-learning software and access the Internet.
Adolescents with type 1 diabetes who live in Isfahan province.
Exclusion criteria:
People with severe psychiatric illnesses.
People with other autoimmune diseases in addition to diabetes.
Those who use psychotropic drugs or substance abuse.
Those with physical and mental disabilities.
Those who are pregnant.
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the restricted randomization method of the type of "random allocation law" will be implemented by a person separate from other researchers. In this way, in the first stage, the required number of specified samples (50 people) will be selected from the people who meet the inclusion criteria. And in the second step, we assign a number from 1 to 50 to each of these people, respectively. In the third step, we produce 50 random numbers without repetition between 1 and 50 by Excel software and this is the random sequence we want. Each of these numbers corresponds to the number assigned to each of the people we have specified in the initial list of 50 selected. In this study, we consider even numbers for the intervention group and odd numbers for the control group, and of course this is not obvious to the participant before performing random allocation.
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 Isfahan University
Street address
Room 325, 3rd Floor, Central Building, University of Isfahan, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۴۱۸۱۷۴۶
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.UI.REC.1399.061
Health conditions studied
1
Description of health condition studied
Type one diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Diabetes distress
Timepoint
Before and after the intervention
Method of measurement
Problem Areas in Diabetes Questionnaire; Iranian version
2
Description
Blood sugar control
Timepoint
Before and after the intervention
Method of measurement
Blood test for hemoglobinA1C
3
Description
Psychological well-being
Timepoint
Before and after the intervention
Method of measurement
Ryff's Scales of Psychological Well-being; Short Form
4
Description
Attentional bias
Timepoint
Before and after the intervention
Method of measurement
Modified Stroop Test (emotional)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Mindfulness-based stress reduction is an 8-week training program that uses formal and informal mindfulness exercises. The regular agenda of each session will include reviewing the homework of the previous session, feedback, troubleshooting questions, teaching content and techniques, meditation skills, discussing stress, coping method and homework. The material presented during the 8 sessions includes the following: Introduction of mindfulness training, training and exercises related to the state of mindfulness exercises, attention to breathing, body scanning exercises, doing sitting care, doing yoga movements, doing mind eating exercises Consciously, taking care of conscious mind walking, preparing a personal mindfulness program. Participants are asked to do mindfulness exercises for 45 minutes on a daily basis as homework.
Category
Behavior
2
Description
Control group: The control group is under routine care and no intervention is performed on them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Sedigheh Tahereh Endocrine and Metabolism Training, Treatment and Research Center
Full name of responsible person
Dr. Maryam Esmaili
Street address
First Floor, Faculty of Educational Sciences and Psychology, University of Isfahan, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
mar_yam_es@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoi Javanmard
Street address
Vice Chancellor for Research and Technology, Hezar Jerib St. Isfahan University of Medical Sciences and Health Services, Building No. 4, No. 4,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Nouri Sari
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 15, Moin Alley, Farrokhi St.
City
Najaf Abad
Province
Isfehan
Postal code
8514758994
Phone
+98 31 4264 4635
Email
z.noooori1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Esfahan
Full name of responsible person
Dr. Maryam Esmaili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology, University of Isfahan, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 5500
Email
mar_yam_es@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan university
Full name of responsible person
Zahra Nouri Sari
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 15, Moin Alley, Farrokhi St.
City
Najaf Abad
Province
Isfehan
Postal code
8514758994
Phone
+98 31 4264 4635
Email
z.noooori1994@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Part of the patients' demographic information and the main outcome can be shared.
When the data will become available and for how long
One year after printing the results
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Zahra Nouri Sari
z.noooori1994@gmail.com
What processes are involved for a request to access data/document