The effect of cognitive-behavioral education combined with motivational interviewing in comparison with cognitive-behavioral education on depression, drug adherence and hemoglobin A1C in patients with type 2 diabetes with depressive symptoms
Determining the effect of cognitive-behavioral education combined with motivational interviewing in comparison with cognitive-behavioral education on depression, drug adherence and hemoglobin A1C in patients with type 2 diabetes with depressive symptoms referred to Zahedan Diabetes Clinic in 2016
Design
Clinical trial with two groups receiving behavioral cognitive training with motivational interview and behavioral cognitive training group, with parallel, non-blind, randomized groups, on 90 patients
Settings and conduct
Diabetes Clinic of Bu Ali Hospital in Zahedan, selecting patients by available sampling method and then dividing them randomly into two groups of cognitive-behavioral training with motivational interview and cognitive-behavioral group
Participants/Inclusion and exclusion criteria
Inclusion criteria
Willingness to participate in the study
Diagnosis of type 2 diabetes based on patient records
Hemoglobin A1C in the amount of 8 and more
Age range 60-20 years
Obtain a score of at least 21 from the Beck Depression Inventory and with the Confirmation of Depression in the Mental Status Examination (MSE).
No known other psychiatric illnesses
6 months to a year of illness passed
Full consciousness and no communication problem
No addiction and substance abuse
No history of participating in a rehabilitation, counseling or training program at the same time
Exclusion criteria
Critical illness, hospitalization, death, or any unexpected occurrence during the study
Do not attend more than one treatment session
Intervention groups
Behavioral cognitive training group with motivational interview and behavioral cognitive training group
Main outcome variables
Depression, hemoglobin a1c, drug adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160924029954N14
Registration date:2020-11-23, 1399/09/03
Registration timing:retrospective
Last update:2020-11-23, 1399/09/03
Update count:0
Registration date
2020-11-23, 1399/09/03
Registrant information
Name
Ali navidian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
alinavidian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-31, 1399/06/10
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
The effect of cognitive-behavioral education combined with motivational interviewing in comparison with cognitive-behavioral education on depression, drug adherence and hemoglobin A1C in patients with type 2 diabetes with depressive symptoms
Public title
the effect of cognitive-behavioral training along with motivational interviewing in comparison with cognitive-behavioral training on depression, medication adherence and level of hemoglobin A1C in type 2 diabetic patients with depression signs
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Hemoglobin a1c in the amount of 8 and more
Obtaining a score of 21 from the Beck Depression Inventory and confirming depression in the mental state examination
No other psychiatric illnesses
6 months to 1 year of illness
Full consciousness and no communication problem
No addiction and substance abuse
No history of participating in a counseling or training rehabilitation program at the same time
Willingness to participate in the study
Diagnosis of type 2 diabetes based on the patient's record
Age range 20 to 60 years
Exclusion criteria:
Critical illness, hospitalization, death, or any unexpected events during the study
Do not attend more than one treatment session
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
From patients diagnosed with type 2 diabetes referred to clinics based on inclusion criteria, by available sampling method, the patients will be selected. Due to the fact that the study population is patients with type 2 diabetes with depression, if they have general conditions, first with the help of Beck Depression Inventory, patients with a score above 21 are identified and then with clinical examination and mental status (MSE) of the depressed. The presence of patients with diabetes will be ensured as one of the most important inclusion criteria. Patients with depressive type 2 diabetes who are selected in this way will be randomly assigned to two groups of cognitive-behavioral education with motivational interview and cognitive-behavioral education. Thus, 90 colored balls (45 white balls for cognitive-behavioral education) And 45 red balls for cognitive-behavioral training combined with motivational interviews) randomly taken out of the container and based on the color of the extracted ball, group membership will be recorded on the list, respectively. By referring to the research environment and selecting and entering eligible patients, gradually and in order of the list, the membership of each patient will be determined in the order of inclusion in the study and the relevant intervention will be performed about him.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
does not have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Zahedan University Of Medical Sciences & Health Services
Street address
Administrative Complex Of Zahedan Medical Science Campus، Persian Gulf Blvd، Dr. Hesabi Square، Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.ZAUMS.REC.1399.190
Health conditions studied
1
Description of health condition studied
Diabetic patients
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
2
Description of health condition studied
depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
People whose Beck questionnaire score is above 21.
Timepoint
"Measurement of depression at the beginning of the study and 3 months after the intervention"
Method of measurement
Beck Depression Inventory
2
Description
The score they get from the Drug Adherence Questionnaire.
Timepoint
Measurement of drug adherence at the beginning of the study and three months after the intervention
Method of measurement
Moriski Drug Adherence Questionnaire
3
Description
Percentage of globin a1c reported by the laboratory
Timepoint
Measurement of hemoglobin a1c at the beginning of the study and three months after the intervention
Method of measurement
Laboratory measurement of hemoglobin a1c
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention procedure: 1: Cognitive-behavioral training with motivational interview: 8 sessions of cognitive-behavioral training with motivational interview Three sessions per week (each session averages 90 to 100 minutes with a break time in each session). Content of motivational interview sessions Session 1: Start the session, introduce the motivational approach and determine the rules of the group. ● Practice determining the stages of change and determining the stage of change ● Ending the session ● Session 2: Start the session and introduce the topic ● Describe one by one the self-care behaviors during the day ● Discuss the activities ● Discuss the Complications of carelessness ● Ending the session ● Session 3: Starting the session and introducing the values and how to determine its hierarchy ● Discovering the conflict between individual values and health-related behaviors ● Introducing and practicing identifying positive dimensions and Negative behavior change ● Measuring the balance of decision-making and ending the session ● Session 4: Start the session and introduce the topic and identify motivators ● Tempters, confidence in behavior control and self-confidence ● Goal setting, vision and Preparing a plan and behavior change plan. دادن Ending the session. Content of cognitive-behavioral sessions: First session: ● Starting the session and introducing the cognitive-behavioral model, determining the group rules ● Familiarity with ABC sheets related to RET treatment Session 2: ● Start the session and introduce the topic of stress and diabetes ● Discuss the effect of stress on diabetes ● Teach stress management techniques ● End the session and present the task of the third session: ● Start the session and introduce Awa Diabetes ● Concern or Anxiety ● Coping with Anxiety ● Ending Session Session 4: ● Starting the Session and Introducing Diabetes and Social Relations ● Diabetes and Social Support ● Learning Ways to Increase Social Support ● Ending Sessions and Periods.
Category
Behavior
2
Description
Intervention group: Intervention group 4: 2 sessions of cognitive-behavioral training 2 sessions per week (face to face and with the help of audio-visual aids): Content of cognitive-behavioral sessions: First session: ● Start the session and introduce the cognitive-behavioral model ● Familiarity with sections D and E of ABC worksheet ● End the session and assign the second session: ● Start the session and introduce the topic of stress and diabetes ● Discuss the effects of stress on diabetes ● Teach stress management techniques ● End the session and present the task of the third session: ● Start the session and introduce complications ● Worrying or Anxiety ● Coping with Anxiety ● Ending the Session Session 4: ● Starting the Session and Introducing Diabetes and Social Relations ● Diabetes and Social Support ● Learning Ways to Increase Social Support ● Ending the Session and Period
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Bu Ali Hospital
Full name of responsible person
Zahra Miri
Street address
Amir Al-Momenin St., Bouali Hospital
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9813617697
Phone
+98 54 3322 8102
Email
mirizahra174@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Normohamad Bakhshani
Street address
Dr Hesabi Square, Zahedan،Vice Chancellorfor Research And Technology Overs Universityof Medical Sciences Zahedan، Iran
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
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
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Miri
Position
Master Student Of Pychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing Midwifery، Mashahir Square، Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9916713335
Phone
+98 54 3721 2364
Email
mirizahra174@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Field Of Fame - Zahedan Nursing And Midwifery Faculty
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
alinavidian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir Street Univercity Of Nursing - Midwifery
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2481
Email
alinavidian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants information is confidential
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
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
the method of implementation of the plan is explained in the thesis
When the data will become available and for how long
En The post-graduation study protocol is described in the thesis
To whom data/document is available
The analysis is done in the dissertation.
Under which criteria data/document could be used
There is no plan to publish it
From where data/document is obtainable
The thesis is explained
What processes are involved for a request to access data/document