The Comparison of Effectiveness of Self-Compassion Education and Lifestyle Modification Education On Psychological Symptoms and Self_Care in type 2 Diabetic Patients
The Comparison of Effectiveness of Self-Compassion Education and Lifestyle Modification Education On Psychological Symptoms and Self-Care in type 2 Diabetic Patients
Design
A randomized clinical trial with parallel groups
Settings and conduct
After collecting the pre-test data, one experimental group of patients with type 2 diabetes received 8 sessions of 45-minute self-compassion based on psychological and self-care components and the other group received 8 sessions of lifestyle modification training. Each week, they were subjected to the above-mentioned components for 90 minutes, then the post-test from all three groups was re-tested, and finally, the effectiveness of the two methods was first measured on each of the psychological and self-care symptom indicators.
Participants/Inclusion and exclusion criteria
Inclusion criteria were type 1 diabetes with physician approval for at least one year, hemoglobin A1c levels above 7%, no psychological treatment since diagnosis, no acute or chronic medical illnesses in medical records such as Epilepsy, Skeletal Diseases, Heart and Respiratory Failures, etc., which can cause problems in blood sampling and prolonged sessions, lack of severe mental illnesses such as psychotic disorders and inadequate use of psychotropic drugs or substance abuse. Now to the psychologist's approval.
Severe complications of diabetes that lead to hospitalization, absence of more than two sessions in treatment sessions and major stress due to unforeseen events will also be considered as exclusion criteria.
Intervention groups
For the first group, lifestyle modification training, for the second group, self-compassion training. The third group will be the control group that will receive no intervention.
Main outcome variables
Psychological Symptoms; Self-Care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200212046474N1
Registration date:2020-02-22, 1398/12/03
Registration timing:registered_while_recruiting
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Ali Mozaffaripour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 5322 2757
Email address
a.mozafari@aiukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-11, 1398/09/20
Expected recruitment end date
2020-03-09, 1398/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Effectiveness of Self-Compassion Education and Lifestyle Modification Education On Psychological Symptoms and Self_Care in type 2 Diabetic Patients
Public title
The Comparison of Effectiveness of Self-Compassion Education and Lifestyle Modification Education On Psychological Symptoms and Self_Care in type 2 Diabetic Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 1 diabetes with a doctor's approval for at least one year
hemoglobin A1c levels above 7%
no acute or chronic medical illness in medical records such as epilepsy, illness Skeletal disorders, heart and respiratory failure, etc., which can cause problems with blood sampling and prolonged sessions
no psychiatric treatment since diagnosis
lack of severe mental illnesses such as psychotic disorders
lack of psychotropic drugs or substance abuse at the moment to the approval of the psychologist
Exclusion criteria:
Severe complications of diabetes that lead to hospitalization
absence of more than two sessions in treatment sessions
major stress due to unforeseen events
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
The block randomization method is performed by the statistical consultant as follows: Randomization is performed in two groups of Self-Compassion Education and Lifestyle Modification Education. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows:
A = Lifestyle Modification Education, B = Self-Compassion Education
In this study, with two groups A and B, we create the following two groups and assign each of the numbers 1 to 2:
-AB-BA
Then we use a random number table to select one of these blocks whenever the numbers 1 and 2 appear, and if there is another number, we consider it null and move on to the next choice. In fact, we have obtained a random sequence of numbers with a random number table that we consider the order of assignment for each number. This way the number of people in the groups will be approximately equal.
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 Hormozgan University Of Medical Sciences
Street address
North Karegar Street 17 Veteran Street 24 P 64
City
Tehran
Province
Tehran
Postal code
1437697419
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.314
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Psychological Symptoms
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Psychological Symptoms (SCL-90-R) 90-Question Scale (Dragoutis et al., 1973)
2
Description
self-care
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Self-Care Scale (Tobert & Glasgow, 1990)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one: Skills that were taught by Alijani et al. (2015) in 8 sessions (two sessions per week and 90 minutes each).
Category
Lifestyle
2
Description
Intervention group II: Skills taught by Gilbert et al. (2012) in a specialized and workshops in 8 sessions (two sessions per week for 90 minutes each).
Category
Lifestyle
3
Description
Control group: The control group received no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Association and Guilanbari County Hospitals
Full name of responsible person
Ali Mozafari Pour
Street address
South Kurdistan Highway - 17th Street - Janbazan Street - 24p 61st 4th West
City
Tehran
Province
Tehran
Postal code
2246578941
Phone
+98 21 2288 1908
Email
a.mozafari@aiukishint.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Roosta
Street address
Islamic Azad University of Kish International Branch, Free Zone Organization Square, Sana'i Boulevard, Kish Island.
City
Kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Email
a.mozafari@aiukishint.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
20
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
Islamic Azad University
Full name of responsible person
Ali Mozaffaripour
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No 6. Fattahpour Alley, Gilan Gharb
City
Kermanshah
Province
Kermanshah
Postal code
7941775883
Phone
+98 83 5322 2757
Fax
Email
A.mozafari@aiukishint.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Mozaffaripour
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No 6. Fattahpour Alley, Gilan Gharb
City
Kermanshah
Province
Kermanshah
Postal code
7941775883
Phone
+98 83 5322 2757
Fax
Email
A.mozafari@aiukishint.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Mozaffaripour
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No 6. Fattahpour Alley, Gilan Gharb
City
Kermanshah
Province
Kermanshah
Postal code
7941775883
Phone
+98 83 5322 2757
Fax
Email
A.mozafari@aiukishint.ac.ir
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing 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
any type of analysis on the data delivered is permitted
From where data/document is obtainable
Ali Mozafaripour, No. 6. Fattahpour Alley, Gilan Gharb.
What processes are involved for a request to access data/document
The request will be sent by email to: a.mozafari@aiukishint.ac.ir