Protocol summary

Study aim
The Effectiveness of Group Therapy Based on Mindfulness and cognitive-behavioral therapy (CBT) in the anxiety, metabolic control and quality of life in type 2 diabetic patients
Design
A randomized clinical trial with parallel groups
Settings and conduct
In order to conduct research, by attending the Diabetes Association of Tehran, while explaining the nature and objectives of the research and obtaining patients' consent, individually from each case, first the initial evaluation in terms of anxiety, metabolic control and pre-test quality of life will be performed. The mindfulness test group will be in 2 sessions of 90 minutes per week for 8 sessions, the cognitive-behavioral group will be in the form of 2 sessions per week for 8 sessions of 90 minutes after the sessions both groups will be anxious again. , Metabolic control and quality of life will respond.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age range 25 to 45 years, having type 2 diabetes, a sense of cooperation and a willingness to participate in medical intervention and being literate was at least a diploma (for reading and writing). Exclusion criteria included chronic mental disorders, severe depression, chronic physical illness with diabetes such as blindness and amputation.
Intervention groups
For the first group of mindfulness cognitive group psychotherapy, For the second group, cognitive behavioral therapy will be performed.
Main outcome variables
anxiety, metabolic control and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200305046699N1
Registration date: 2020-04-22, 1399/02/03
Registration timing: registered_while_recruiting

Last update: 2020-04-22, 1399/02/03
Update count: 0
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
Fatemeh Rezaei kookhdan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2233 9948
Email address
f.rezaeikookhdan@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-07, 1398/10/17
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Group Therapy Based on Mindfulness and cognitive-behavioral therapy (CBT) in the anxiety, metabolic control and quality of life in type 2 diabetic patients
Public title
The Effectiveness of Group Therapy Based on Mindfulness and cognitive-behavioral therapy (CBT) in the anxiety, metabolic control and quality of life in type 2 diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 25 to 45 years Having type 2 diabetes Having a sense of cooperation and satisfaction in participating in therapeutic intervention Have at least a diploma literacy (to read and write)
Exclusion criteria:
Having chronic mental disorders Having severe depression Having a chronic physical illness with diabetes, such as blindness Amputation
Age
From 25 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Using the block randomization method by the statistical consultant, the following randomization is done in 3 groups of mindfulness-based cognitive therapy, cognitive-behavioral therapy, and control: First, the list of names of qualified people is provided and coded. In block randomization, the number of participants in all groups will be very close, this is done by building blocks of sequences and intersections so that the same number of participants are allocated to study groups within each group. First, we encode the groups based on the Latin letters as follows: A = mindfulness-based cognitive therapy, B = cognitive-behavioral therapy and C control group In this study, with three groups A, B, and C, we create the following six groups and assign the numbers 1 to 6 to each: ABC-ACB-BAC-BCA-CAB-CBA Then, using the table of random numbers, we contract that if the numbers 1, 2, 3, 4, 5, 6, and 6 appear in order, one of these blocks will be selected, and if another number appears, we will assume it to be null and void and move on to the next selection. In fact, we have obtained a random sequence of numbers with a table of random numbers, which we consider the order of the assigned allocation for each number. In this way, the number of people in the groups will be almost 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.2, Shahid Karami Alley, North Allameh, Sa'adatabad
City
Tehran
Province
Tehran
Postal code
2255689744
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.317

Health conditions studied

1

Description of health condition studied
Diabetes Type II
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Anxiety
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Spielberger State-Trait Anxiety Inventory

2

Description
Metabolic control
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Blood glucose test

3

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
Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group one: It is a collection of training and treatment instructions and homework that will be presented to people during 8 sessions of one and a half hours. The Practical Guide to Mindfulness Therapy will be used to help people (Kabat-Zinn, 2012), and the Personalized Mindfulness Therapy Handbook will be used as the main source of therapeutic techniques. Mindfulness-based cognitive therapy was taught to participants based on Kabat‐Zinn (2012) in 8 sessions (two sessions per week, each session for 90 minutes) and during one month.
Category
Treatment - Other

2

Description
Second Intervention Group: It is a collection of training and treatment instructions and homework that will be presented to people during 8 sessions of one and a half hours. The Practical Guide to Cognitive-Behavioral Therapy will be used to help people take control of their lives (Lam, 2008), and the Individual Guide to Cognitive Behavioral Therapy and the Guide to Group Cognitive Behavioral Therapy will be used as the main source of therapeutic techniques. But there is no limit to the use of other cognitive-behavioral techniques. In this study, cognitive-behavioral intervention with the help of Lam Training Package (2008) was taught to participants in 8 sessions (one session per week and 90 minutes per session) for one and a half months.
Category
Treatment - Other

3

Description
Control group: No Intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Association of Tehran
Full name of responsible person
Fatemeh Rezaei Kookhdan
Street address
No. 2, Shahid Karami Alley, North Allameh, Sa'adatabad
City
Tehran
Province
Tehran
Postal code
2255689744
Phone
+98 21 8974 5679
Email
mrezaei1388@yahoo.com

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
Fatemeh Rezaei kookhdan
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.2, west 14th, North Allameh st, Saadatabad
City
Tehran
Province
Tehran
Postal code
2255689744
Phone
+98 21 2233 9948
Fax
Email
f.rezaeikookhdan@iaukishint.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Rezaei kookhdan
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.2, west 14th, North Allameh st, Saadatabad
City
Tehran
Province
Tehran
Postal code
2255689744
Phone
+98 21 2233 9948
Fax
Email
f.rezaeikookhdan@iaukishint.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Rezaei kookhdan
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.2, west 14th, North Allameh st, Saadatabad
City
Tehran
Province
Tehran
Postal code
2255689744
Phone
+98 21 2233 9948
Fax
Email
f.rezaeikookhdan@iaukishint.ac.ir

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
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