Comparison of the effectiveness of metacognition Versus therapeutic reality on the treatment of care, quality of life, depression and biological variables in type 2 diabetes
The main purpose of this study was to determine and compare the effectiveness of metacognitive therapy and reality therapy on depression, self-care, quality of life and biological variables in patients with type 2 diabetes.
Design
The clinical trial will have a parallel control group, single-blind and randomized block groups on 75 patients.
Settings and conduct
This research is a randomized controlled trial and will benefit from three parts : pre - test , intervention and post - test and in Imam Ali hospital in Karaj
Participants/Inclusion and exclusion criteria
Inclusion criteria: completion and signing of written consent; no abuse of drugs and psychotropic drugs; age between 30-60 years old; more than a year has passed since the diagnosis; the minimum depression score is 8; fasting sugar should not exceed 135 mg / dL; HbA1c should not exceed 8%; failure to receive psychological treatment during the last 3 months; absence of severe physical diseases caused by diabetes such as kidney failure, vision and ...
Criteria for non-entry: creating severe physical diseases caused by diabetes such as kidney failure, vision and ...; receiving psychological therapies during the intervention; take any sedatives or neuroleptics; increase in the dose of diabetes-related drugs.
Intervention groups
1.Metacognitive therapy group; 2. The reality therapy group that has 8 sessions of intervention each; 3. The control group that will receive the treatments at the end and if they wish.
Main outcome variables
Self-care; quality of life; depression; biomarkers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200916048737N1
Registration date:2020-10-16, 1399/07/25
Registration timing:retrospective
Last update:2020-10-16, 1399/07/25
Update count:0
Registration date
2020-10-16, 1399/07/25
Registrant information
Name
Maryam Nasirdehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3254 9648
Email address
nasirdehghanmaryam58@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of metacognition Versus therapeutic reality on the treatment of care, quality of life, depression and biological variables in type 2 diabetes
Public title
The effectiveness of metacognitive therapy and reality therapy on self-care behavior, quality of life, depression and biological variables in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Completion and signing of written consent by the subject
No abuse of drugs and psychotropic drugs
Age between 30-60 years
More than a year has passed since the diagnosis of type 2 diabetes
The minimum depression score is 8
Fasting sugar should not exceed 135 mg per deciliter
HbA1c should not exceed 8%
Failure to receive psychological treatment during the last 3 months
Absence of severe physical diseases caused by diabetes such as kidney failure, vision and ...
Exclusion criteria:
Development of severe physical diseases caused by diabetes such as kidney failure, vision and ...
Receiving psychological therapies during the intervention
Consumption of any sedative or neuropsychiatric drugs
Increase in the dose of diabetes-related drugs
More than two absences
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; because we have three study groups, name each group with the English letters A. B and C and write the letters A, B and C in three envelopes or three pieces of paper and close them and then randomly remove one of the envelopes. And according to the letter inserted in that person, we attribute it to that group, and with the arrival of the second person, we choose one of the two remaining envelopes and assign that person to that group, and then the third person to the group written in the next envelope. Which has not been selected in the previous two selections will be awarded and for the fourth to sixth persons the steps 2 to 5 will be repeated and then for the next three persons and ... until the required number of samples is completed in all three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be unaware of the allocation of intervention groups, ie which treatment group they will be in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Karaj Azad University
Street address
Moazzen Boulevard,Rajai Shahr
City
Karaj
Province
Alborz
Postal code
3149968111
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.IAU.K.REC.1399.040
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention, immediately after the intervention and one month and three months later
Method of measurement
Beck Depression Inventory
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention, immediately after the study and one month and three months later
Method of measurement
SF36 Health Status Questionnaire
2
Description
Self care
Timepoint
Before the intervention, immediately after the study and one month and three months later
Method of measurement
Tobert and Glasgow Self-Care Questionnaire
3
Description
Fasting blood sugar
Timepoint
Before the intervention, immediately after the study and one month and three months later
Method of measurement
blood test
4
Description
Glycosylated hemoglobin
Timepoint
Before the intervention, immediately after the study and one month and three months later
Method of measurement
Blood test
5
Description
Blood pressure
Timepoint
Before the intervention, immediately after the study and one month and three months later
Method of measurement
Analog blood pressure monitor
Intervention groups
1
Description
Intervention group 1: Reality therapy in 8 sessions, Reality therapy protocol: Session 1: Greetings and acquaintance of group members with each other, group rules and establishing emotional relationships between members and therapist and performing tests Session 2: Training Concepts of reality therapy and examining and focusing on self-knowledge, identifying the strengths and weaknesses of people. Session 3: Introducing general behavior and acquainting people with the four components of general behavior (thought, action, feeling and physiology), teaching decision-making skills and The importance of the present in this treatment Session 4: Explain and introduce the four conflicts and forced behaviors of the session 5: Familiarity with emotions such as depression from the perspective of reality therapy and relaxation skills training Session 6: Introducing destructive and constructive behaviors in relationships and life education Session 7: Teaching the ten principles of the theory of choice and responsibility Classification and execution of tests
Category
Lifestyle
2
Description
Intervention group 2: Metacognitive therapy which contains 8 sessions.Therapeutic protocol of metacognitive therapySession 1: Performing tests, stating the rules, establishing a therapeutic relationship and proper communication between membersSession 2: Explaining the logic of metacognition, teaching documents: blaming or gaining credibility and recognitionSession 3: Review the previous session and teach the topic of early conclusionSession 4: Review previous sessions and learn how to change the belief systemSession 5: Review previous sessions and empathy trainingSession 6: Review previous sessions and memory enhancement trainingSession 7: Reviewing previous sessions and learning to avoid prejudice (tagging)Session 8: Review the previous sessions and teach self-esteem and mood and test performance
Category
Lifestyle
3
Description
Control group: Control group: This group does not receive treatment until the end of the sessions and until the quarterly follow-up, but in the end, if desired, metacognitive and reality therapies are performed on them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital in Karaj
Full name of responsible person
Habibe Taghavi Kojidi
Street address
Azimiyeh roads, At the beginning of Chalous road, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3256 2358
Email
dr.taghavi76@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Ghorbani
Street address
Moazzen Boulevard, Rajai Shahr, Karaj
City
karaj
Province
Alborz
Postal code
3149968111
Phone
+98 26 3418 2727
Fax
Email
m_ghorbani@kiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Karaj Branch
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Niloofar Tahmouresi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Karaj, Moazzen Boulevard, Rajai Shahr, Karaj
City
Karaj
Province
Alborz
Postal code
3149968111
Phone
+98 26 3418 2301
Email
niloofartahmouresi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Nasirdehghan
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Karaj, Moazzen Boulevard, Rajai Shahr, Karaj
City
karaj
Province
Alborz
Postal code
3149968111
Phone
+98 26 3425 9571
Email
nasirdehghanmaryam58@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Nasirdehghan
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Karaj, Moazzen Boulevard, Rajai Shahr, Karaj
City
karaj
Province
Alborz
Postal code
3149968111
Phone
026-34259571-9
Email
nasirdehghanmaryam58@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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
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
The access period starts after printing
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
In case of similar and complementary researches, the information of the present research will be available
From where data/document is obtainable
Contact by email
nasirdehghanmaryam58@gmail.com
What processes are involved for a request to access data/document
The applicant is required to email his / her scientific research documents and after access, he / she can access the information.