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Comparison of the Effectiveness of Cognitive-Behavioral Therapy Based on Mindfulness and Education on Health Promoting Lifestyle on Psychological Well-being, Hope and Quality of Life in Patients with Diabetes

Protocol summary

Study aim
Comparison of the Effectiveness of Cognitive-Behavioral Therapy Based on Mindfulness and Education on Health Promoting Lifestyle on Psychological Well-being, Hope and Quality of Life in Patients with Diabetes
Design
A randomized controlled clinical trial with parallel groups, Randomized block, sample size 45 (15 persons per group)
Settings and conduct
Both groups completed psychological well-being, hope and quality of life questionnaires before beginning the sessions. Experimental group A (Cognitive-behavioral therapy based on mindfulness) and experimental group B (health-promoting lifestyle education) were trained weekly in diabetic patients in diabetes centers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetes with physician-approved for at least one year, hemoglobin A1c levels above 7%, having a minimum age of 20 and a maximum of 50 years, having a minimum secondary education, not receiving psychological treatment. Since diagnosis, acute or chronic medical illnesses such as epilepsy, skeletal diseases, heart, and respiratory failure, etc. which can cause problems in blood sampling and long sessions, lack of severe mental illnesses such as disorders Psychotic and non-use of psychotropic drugs or substance abuse at present. Exclusion criteria: Severe complications of diabetes that lead to hospitalization, absence of more than two sessions in treatment sessions and major stress due to unforeseen events.
Intervention groups
In the first group, there will be no mindfulness-based cognitive-behavioral therapy, in the second group health-promoting lifestyle training and in the third group, there will be no intervention control.
Main outcome variables
Psychological well-being, hopefulness, and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200226046625N1
Registration date: 2020-03-15, 1398/12/25
Registration timing: retrospective

Last update: 2020-03-15, 1398/12/25
Update count: 0
Registration date
2020-03-15, 1398/12/25
Registrant information
Name
Maryam Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 9783
Email address
m.ghorbani@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-15, 1398/09/24
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Cognitive-Behavioral Therapy Based on Mindfulness and Education on Health Promoting Lifestyle on Psychological Well-being, Hope and Quality of Life in Patients with Diabetes
Public title
Comparison of the Effectiveness of Cognitive-Behavioral Therapy Based on Mindfulness and Education on Health Promoting Lifestyle in In treatment of diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes with a doctor's approval for at least one year Hemoglobin A1c levels above 7% Minimum age of 20 and maximum of 50 years Minimum secondary education equivalent Lack of psychological treatment since diagnosis Lack of acute or chronic medical illnesses such as epilepsy, skeletal diseases, heart and respiratory failure, etc. which can cause problems in blood sampling and long sessions Lack of severe mental illness such as psychotic disorders No psychotropic drugs or substance abuse at present
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
From 20 years old to 50 years old
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
The block randomization method is performed by the statistical consultant as follows: Randomization is performed in 3 groups of Cognitive-Behavioral Therapy based on mindfulness, health-promoting lifestyle training and control group: First, the list of eligible people is provided and coded. Be. 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 = Mindfulness-based Cognitive-Behavioral Therapy, B = Health-Promoting Lifestyle Training, and C Control Group In this study with three groups A, B and C we create the following six groups and assign 1 to 6 each: ABC-ACB-BAC-BCA-CAB-CBA Then we use a random number table to select one of these blocks whenever the numbers 1, 2, 3, 4, 5, 6 appear, and if the other number appears, consider null and go 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
No. 64, Janbazan Ave., North Karegar Street
City
Tehran
Province
Tehran
Postal code
2245986743
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.325

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 Well-being
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Ryff Psychological Well-being Scale

2

Description
Quality of Life
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
The World Health Organization Quality of Life Questionnaire

3

Description
Hopefulness
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Snyder hope scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In the present study, the goal of mindfulness-based cognitive-behavioral therapy is 8 sessions of mindfulness-based cognitive-behavioral therapy that were held two sessions per week (one month) and each session 60 minutes.
Category
Treatment - Other

2

Description
Intervention group 2: In this study, the purpose of health promoting lifestyle training is 10 sessions of health promoting lifestyle training that were held two sessions per week (one and a half months) and each session 60 minutes.
Category
Treatment - Other

3

Description
Control group: No Intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers and Diabetes Association of Tehran
Full name of responsible person
Maryam Ghorbani
Street address
No. 64, Janbazan Ave., North Karegar Street
City
Tehran
Province
Tehran
Postal code
2245986743
Phone
+98 21 6655 9783
Email
m.ghorbani@iaukishint.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
Info@Iaukishint.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
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
Islamic Azad University
Full name of responsible person
Maryam Ghorbani
Position
Ph. D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sattarkhan St., Khosrow South, Atabaki Mehr Ave.
City
Tehran
Province
Tehran
Postal code
2245986743
Phone
+98 21 6655 9783
Fax
Email
m.ghorbani@iaukishint.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Ghorbani
Position
Ph. D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sattarkhan St., Khosrow South, Atabaki Mehr Ave.
City
Tehran
Province
Tehran
Postal code
2245986743
Phone
+98 21 6655 9783
Fax
Email
m.ghorbani@iaukishint.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Ghorbani
Position
Ph. D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sattarkhan St., Khosrow South, Atabaki Mehr Ave.
City
Tehran
Province
Tehran
Postal code
2245986743
Phone
+98 21 6655 9783
Fax
Email
m.ghorbani@iaukishint.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
Maryam Ghorbani Sattarkhan St., Khosrow South, Atabaki Mehr Ave.
What processes are involved for a request to access data/document
The request will be sent by email to: m.ghorbani@iaukishint.ac.ir
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