Comparing the effectiveness of mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy on self-care activities, practice and acceptance of diabetes, fear of hypoglycemia, and quality of life in patients with type 2 diabetes
Comparing the effectiveness of cognitive therapy based on mindfulness and acceptance and commitment therapy on self-care activities, practice and acceptance of diabetes, fear of hypoglycemia and quality of life in patients with type 2 diabetes
Design
A clinical trial with two intervention groups and one control group, with parallel groups, no blinding, randomized, on 45 patients with type 2 diabetes, was used for randomization by lottery.
Settings and conduct
After obtaining code of ethics and permission from Azad University of Neishabur, he will refer to Parsian Diabetes Clinic in Mashhad. In the following, 45 people will be selected from the mentioned statistical population using the available sampling method and will be randomly divided into three groups of 15 people, the experimental group and the control group. Then pre-test, treatment sessions and post-test and two-month follow-up will be done.
Participants/Inclusion and exclusion criteria
Entry criteria
- Age between 30 and 50 years
- Having a minimum cycle degree
- Not suffering from psychiatric diseases (based on the patient's records that are asked about the person himself, as well as consultation by a specialist psychologist and review of the patient's medical record in the clinic)
- Not using psychiatric drugs
- Failure to receive any similar training programs before and during interventions
- Having informed consent to participate in the study
Exit criteria
- Voluntary withdrawal from the research
- Absence of more than two sessions in training sessions
- Lack of proper cooperation
Intervention groups
mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy
Main outcome variables
Improving self-care activities, improving the practice and acceptance of diabetes, reducing the fear of hypoglycemia and improving the quality of life in patients with type 2 diabetes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240211060960N1
Registration date:2025-02-08, 1403/11/20
Registration timing:retrospective
Last update:2025-02-08, 1403/11/20
Update count:0
Registration date
2025-02-08, 1403/11/20
Registrant information
Name
Tina Karbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3604 4326
Email address
karbasit2017@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-01, 1403/04/11
Expected recruitment end date
2024-08-01, 1403/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy on self-care activities, practice and acceptance of diabetes, fear of hypoglycemia, and quality of life in patients with type 2 diabetes
Public title
Comparing the effectiveness of mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy on self-care activities, practice and acceptance of diabetes, fear of hypoglycemia, and quality of life in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Age between 30 and 50 years
- having a minimum cycle degree
- Lack of psychiatric diseases (patients' records questioned by the person as well as consultation by a specialist psychologist and reviewing the patient's medical record at the clinic)
- Failure to use psychiatric drugs
- No drug abuse
Failure to receive any similar training programs before and during interference
- Regular participation in therapeutic sessions (cognitive therapy based on mentality and admission and commitment treatment) according to the therapy
- Having informed consent to participate in the study
Exclusion criteria:
Voluntary withdrawal from research
Absence of more than two sessions in training sessions
Lack of proper cooperation
Age
From 30 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
It will be done through simple randomization. According to this method, the names of each selected member are written on the paper as an example of the research. They are thrown into a box for drawing, then picking the paper pieces one by one and the first 15 (1-15) part of the Cognitive Therapy Experimental Group. On the consciousness, 15 seconds (16 to 30) of the Acceptance and commitment Experimental group and the last 15 (31 to 45) whose names come out of the lottery box will be members of the control group.
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
Ethical Committee of Azad University of Neyshabur branch
Street address
Pazhoohesh Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
۹۳۱۹۹۷۵۸۵۳
Approval date
2024-04-03, 1403/01/15
Ethics committee reference number
IR.IAU.Neyshabur.REC.1403.001
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
The score of self-care activities in the self-care questionnaire
Timepoint
At the beginning of the study, after treatment sessions and follow-up two months after treatment
Method of measurement
Self-care: In this research, the state of self-care is the score that the subject will get from the self-care questionnaire of patients with diabetes Tobert et al. (2000).
2
Description
the score of diabetes practice and acceptance in the diabetes practice and acceptance questionnaire
Timepoint
At the beginning of the study, after treatment sessions and follow-up two months after treatment
Method of measurement
Acceptance and Action: In this research, acceptance and action are the scores that the subject will get from the Acceptance and Action Questionnaire AAQ-R Bund et al. (2007).
3
Description
the fear of hypoglycemia score in the hypoglycemia questionnaire
Timepoint
At the beginning of the study, after treatment sessions and follow-up two months after treatment
Method of measurement
Quality of life: In this research, quality of life is the score that the subject will get from the questionnaire on the quality of life of diabetic patients by Broth et al. (2004).
4
Description
the quality of life score in the quality of life questionnaire of patients with diabetes
Timepoint
At the beginning of the study, after treatment sessions and follow-up two months after treatment
Method of measurement
Fear of hypoglycemia: In this research, fear of hypoglycemia is the score that the subject will get from the fear of hypoglycemia questionnaire or HFS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Cognitive therapy based on mindfulness: Cognitive therapy based on mindfulness or MBCT is one of the types of therapy based on cognition and behavior. This therapy integrates presence of mind as a treatment goal with exercises such as conscious thought cessation and non-judgmental observation of one's own thoughts. Mindfulness emerges through purposeful and non-judgmental attention to the present moment and situation in a specific way. In this research, the experimental group of 8 sessions of 60 minutes each week are treated based on cognitive-behavioral protocol interventions based on mindfulness. This training program is based on Crane's book on cognitive therapy based on mindfulness.
Category
Treatment - Other
2
Description
Intervention group 2: Treatment based on commitment and acceptance: therapy based on commitment and acceptance is a mixture of 4 approaches: awareness, acceptance, commitment and behavior change. The basis of treatment is based on the acceptance and commitment of Relational Frame Theory (RFT). which is a result of the third wave of psychotherapy introduced by Steven Hayes and his colleagues in 1982. The word ACT is actually derived from: A: accepting thoughts and feelings and being in the present, C: choosing a valuable direction and T: acting. Treatment sessions will be held in the form of 8 sessions of 60 minutes each week.
Category
Treatment - Other
3
Description
Control group: The control group will not receive treatment, but after a two-month follow-up, it will undergo treatment sessions chosen by the members.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsian diabetes clinic
Full name of responsible person
AliAkbar Raouf Saeb
Street address
No. 222, between lashgar Cross and bisim Cross, Bahar Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 3858 4040
Email
Info@parsiandiabetes.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Reza Bazzaz Zadeh Torbati
Street address
Pazhoohesh Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
۹۳۱۹۹۷۵۸۵۳
Phone
+98 51 4262 1901
Email
Neyshabur@iau-neyshabur.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
Tina Karbasi
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.87, Jalal AlAhmad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188878361
Phone
+98 51 3604 4326
Email
Karbasit2017@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tina karbasi
Position
Ph D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 87, Jalal Al Ahmad 21 Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9188878361
Phone
+98 51 3604 4326
Email
Karbasit2017@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tina karbasi
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 87, Jalal Al Ahmad 21 Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188878361
Phone
+98 51 3604 4326
Email
Karbasit2017@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data will be published in the student's article and thesis, and the identity information of the participants will be preserved.
When the data will become available and for how long
Since 1404
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
After completing the treatment and follow-up sessions, writing a doctoral thesis, defending the thesis and research articles will be published in reputable scientific journals.
From where data/document is obtainable
Tina karbasi
What processes are involved for a request to access data/document
A message containing the request for research documents should be sent to the email of the author of the article.