Determining the Effect of 8-Week Psychological Therapy on Positive Depression, Anxiety, Stress and Glycemic Control Indicators in Type 2 Diabetes
Design
Clinical trials with control group, with parallel groups, randomized
Settings and conduct
The study was conducted in 1398 in Isfahan. The target population of type 2 diabetes mellitus, referred to the Imam Ali Hospital's comprehensive health center (Isfahan).
Participants/Inclusion and exclusion criteria
Type 2 diabetes with the approval of a specialist
The history of regular visits to the center for at least the past 6 months
Age between 30 and 59 years
HbA1C between 9-7%
Absence of alcohol and substance abuse
Have at least high school education level
Exclusion Criteria
Absence in more than 3 sessions in the treatment process
Unwillingness to continue treatment
The occurrence of major stresses and unexpected accidents in each stage of the study
Acute psychological illness in each stage of the study
Having chronic illnesses, such as cancer or any other serious medical condition, except diseases associated with complications of diabetes or diseases associated with diabetes
Need to start insulin treatment during the design
Participate in psychotherapy sessions outside the research project protocol.
Intervention groups
A total of 40 people are randomly selected for each group, and then the participants are allocated to intervention and control groups.
For the intervention group, eight sessions of 2 hours a week, once a positive psychological education is conducted by a psychologist with a skill in this field. And then they will do homework for 4 weeks, which is reported weekly in the form of a self report.
Main outcome variables
HbA1C; FBS; The amount of anxiety; Depression and stress levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N27
Registration date:2019-02-26, 1397/12/07
Registration timing:prospective
Last update:2019-02-26, 1397/12/07
Update count:0
Registration date
2019-02-26, 1397/12/07
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of positive psychology’s effect on depression, anxiety, stress and glycemic control in diabetic type 2 patients
Public title
Evaluation of positive psychology’s effect on depression, anxiety, stress and glycemic control in diabetic type 2 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes with the approval of a specialist
The history of regular visits to the center for at least the past 6 months
Age between 30 and 59 years
HbA1C between 9-7%
Absence of alcohol and substance abuse
Have at least high school education level
Ability to attend medical sessions
Lack of pregnancy and lactation
The history of diabetes for at least 6 months
Earn a minimum score of 7 from the DASS 21 questionnaire before starting the study
Failure to receive psychological treatment in the past year
Exclusion criteria:
Absence in more than 3 sessions in the treatment process
Unwillingness to continue treatment
The occurrence of major stresses and unexpected accidents in each stage of the study
Acute psychological illness in each stage of the study
Having chronic illnesses, such as cancer or any other serious medical condition, except diseases associated with complications of diabetes or diseases associated with diabetes
Need to start insulin treatment during the design
Participate in psychotherapy sessions outside the research project protocol.
Age
From 30 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomization block, randomization unit: Individual, Random layer: not done Randomization, tool: Random sequence generation software (Excel), How to create random sequence: Using random blocks, each block contains 4 people And assign a number from 1 to 6 to each block.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical sciences, Hezar Jareeb street,Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2018-02-09, 1396/11/20
Ethics committee reference number
IR.MUI.REC.1396.3.369
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
beginning of study and 8 weeks after intervention
Method of measurement
Using the Pars Test Kit, Made by Iran
2
Description
HbA1C
Timepoint
beginning of study and 8 weeks after intervention
Method of measurement
Using the Pars Test Kit, Made by Iran
3
Description
Anxiety, depression and stress
Timepoint
beginning of study and 8 weeks after intervention
Method of measurement
DASS 21 anxiety, depression and stress questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8 weekly 2-hour sessions of Positive Psychology Training is conducted by a PhD in Psychology. And then they will do homework for 4 weeks, which is reported weekly in the form of a self report.
Category
Rehabilitation
2
Description
Control group: There is no treatment on this group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali City Comprehensive Health Center
Full name of responsible person
Dr Anahita Babak
Street address
W Toosi St, Isfahan, Iran
City
Isfehan
Province
Isfehan
Postal code
81649 69459
Phone
+98 31 3661 7371
Email
babakanahita@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjooe Javanmard
Street address
Medical School of Isfahan, Deputy of Research
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8092
Fax
+98 31 3669 2174
Email
sh_haghjoo@med.mui.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Anahita Babal
Position
Associated Proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Medical University, Hezar Jarib Ave, Isfahan, Iran
City
isfehan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3792 7653
Email
babakanahita@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Anahita Babak
Position
Associated Proffessor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Alzahra hospital, Sofe street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31366855555
Fax
+98 31 3624 4221
Email
babakanahita@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Anahita Babak
Position
Associated Proffessor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Alzahra hospital, Sofe street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31366855555
Fax
+98 31 3624 4221
Email
babakanahita@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
whole data will be available
When the data will become available and for how long
immediately after publishing manuscript
To whom data/document is available
to whom is in need of this data
Under which criteria data/document could be used
Email to Dr Anahita Babak E.Mail: babakanahita@yahoo.com
From where data/document is obtainable
Dr Anahita Babak E.Mail: babakanahita@yahoo.com
What processes are involved for a request to access data/document