Comparing the effectiveness of cognitive-behavioral therapy and mindfulness-based cognitive therapy on cognitive emotion regulation, psychological well-being, diabetes-related distress, and self-care in patients with type 2 diabetes
Comparison of the effectiveness of cognitive-behavioral therapy and cognitive therapy based on mindfulness on cognitive regulation of emotion, psychological well-being, distress related to diabetes and self-care of patients with type 2 diabetes
Design
Quasi-experimental with pre-test and post-test design with control group
Settings and conduct
we will be randomly placed in two experimental groups, CBT and MBCT, and a control group. Statistical sample: 30 patients will be selected as experimental group 1 and experimental group 2, and 15 patients will be selected as control group (the method of assignment to three random groups will be simple). Kalinzo and Ongbazi, 2007; Quoting Delavar and Kushki (2012), they mentioned the same number of samples required for experimental designs.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the sample are:
Received a diagnosis of type 2 diabetes by an endocrinologist
Age between 25 and 45 years
Has not taken any neuropsychiatric medication in the past three months
Not suffering from a serious physical illness such as cancer, MS, Alzheimer's, etc.
Not suffering from a serious psychiatric illness such as psychosis or the like (based on the initial clinical interview)
Have at least a high school diploma.
Complete an informed consent agreement regarding participation in the research project
Not undergoing treatment or other psychological interventions during the research.
Exclusion criteria for the sample group are:
Absent more than two sessions in treatment
It is known that the patient has taken neuropsychiatric medication or substances in the past 5 months
Suffering from mania or a psychotic disorder
Intervention groups
CBT
MBCT
Main outcome variables
Self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260719070251N1
Registration date:2026-08-17, 1405/05/26
Registration timing:prospective
Last update:2026-08-17, 1405/05/26
Update count:0
Registration date
2026-08-17, 1405/05/26
Registrant information
Name
Bahram Mirzaian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 9528
Email address
bahrammirzaian@iau.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2027-03-16, 1405/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of cognitive-behavioral therapy and mindfulness-based cognitive therapy on cognitive emotion regulation, psychological well-being, diabetes-related distress, and self-care in patients with type 2 diabetes
Public title
Comparing the effectiveness of cognitive-behavioral therapy and cognitive therapy based on mindfulness in patients with type 2 diabetes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Getting a diagnosis of type 2 diabetes from an endocrinologist
Age between 25 and 45 years
She has not taken any psychiatric medication in the past three months.
Not have a terminal physical illness such as cancer, MS, Alzheimer's, etc.
Do not suffer from a serious psychiatric illness such as psychosis or the like (based on the initial clinical interview)
They must have at least a high school diploma.
Complete an informed consent agreement regarding participation in the research project.
Do not undergo treatment or other psychological interventions during the research.
Exclusion criteria:
Presence of a severe and active psychiatric disorder, including psychotic disorders or a manic episode, based on the initial clinical interview.
Age
From 25 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Islamic Azad University, Sari Branch
Street address
7th km of Darya Road (Farahabad), Azad University
City
Sari
Province
Mazandaran
Postal code
48164-194
Approval date
2026-05-25, 1405/03/04
Ethics committee reference number
IR.IAU.SARI.REC.1405.086
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Cognitive emotion regulation
Timepoint
Before intervention
Method of measurement
After intervention
2
Description
: Psychological well-being
Timepoint
before intervention
Method of measurement
after intervention
3
Description
Diabetes distress
Timepoint
before intervention
Method of measurement
after intervention
4
Description
Self-care
Timepoint
before intervention
Method of measurement
after intervention
Secondary outcomes
1
Description
Self-care
Timepoint
Before intervention
Method of measurement
After intervention
Intervention groups
1
Description
Intervention Group 1:Patients with type 2 diabetes who are assigned to this group will receive Mindfulness-Based Cognitive Therapy (MBCT) over 8 weekly sessions. The sessions will include mindfulness training and exercises, body scan, focused breathing, awareness of thoughts and emotions, acceptance, seated meditation, and other exercises specified in the treatment protocol.
Category
Other
2
Description
Intervention group: Intervention Group 2:Patients with type 2 diabetes who are assigned to this group will receive Cognitive Behavioral Therapy (CBT) over 12 weekly sessions. The sessions will include education about diabetes and psychological factors, identification of automatic thoughts, behavioral activation, goal setting, identification of cognitive distortions, cognitive restructuring, and relapse prevention.
Category
Other
3
Description
Control group: Control Group:Patients with type 2 diabetes who are assigned to the control group will not receive any psychological intervention during the intervention period and will be placed on a waiting list. After completion of the study, the intended treatment will be provided to this group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Toba clinic
Full name of responsible person
Zahra Zamanpoor
Street address
Khazar Sq
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3303 2891
Email
Rohaaam2018@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghahraman Mahmoodi
Street address
Khzar Sq
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3303 3751
Email
Rohaaam2018@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Zahra Zamanpoor
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khazar Sq
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3303 2891
Email
Rohaaam2018@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Bahram Mirzaian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Khazar Sq
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3303 2891
Email
Bahrammirzaian@iau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Zamanpoor
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khazar Sq
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3303 2891
Email
Rohaaam2018@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available