Regarding the high prevalence of type 2 diabetes, its severe complications in the community, the association of this disease with the lifestyle of the individual and the lack of medical interventions. we should used psychological interventions along with medical interventions. The aim of this study was to determine the effectiveness of Acceptance and Commitment Therapy on Self-efficacy and HbA1C in type 2 diabetic patients.
Design
A clinical trial with a pretest and post test design with a control group that 60 patients with diagnosis type 2 diabetes were randomly assigned to two groups of intervention and control
Settings and conduct
Before and after the intervention,from both groups received questionnaires and HbA1C tests
Participants/Inclusion and exclusion criteria
Inclusion criteria
Having an age of 40 til 55 years
Diagnosis of Type II diabetes by Endocrinologist
Having a degree in secondary education or higher
Having Type 2 diabetes at least for one year
Exit criteria
Receiving another psychological treatments in a recent year and research time
Failing to participate in more than two sessions of the study
Need to change medication or hospitalization during the study
Having diabetes complications that prevent the study
Intervention groups
Intervention group: The intervention group includes routine medicine treatment that depends on Endocrinologist diagnosis and receiving Acceptance and Commitment Therapy in eight 90- minutes sessions for two months.
Control group: Control group includes routine medicine treatment that depends on Endocrinologist diagnosis without psychotherapy .
Main outcome variables
Independent variable: Acceptance and Commitment Therapy
Dependent variable: Self-efficacy and HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181127041774N1
Registration date:2019-01-04, 1397/10/14
Registration timing:retrospective
Last update:2019-01-04, 1397/10/14
Update count:1
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
Fahimeh Nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
f99n99@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-25, 1396/07/03
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
2017-09-25, 1396/07/03
Actual recruitment end date
2017-11-01, 1396/08/10
Trial completion date
2019-02-01, 1397/11/12
Scientific title
Effectiveness of group Acceptance and Commitment Therapy on Self-efficacy and HbA1C in type II diabetic patients.
Public title
Effect of ACT on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 55 years old
Diagnosis of type 2 diabetes by doctor
Having a degree in secondary education or higher
Having Type 2 diabetes at least for one year
Exclusion criteria:
Receiving another psychological treatments in a recent year and research time
Failing to participate in more than two sessions of the study
Need to change medication or hospitalization during the study
Having diabetes complications that prevent the study
Age
From 40 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized
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 Kashan university of medical science
Street address
Qotb ravandi blv
City
kashan
Province
Isfehan
Postal code
8713781147
Approval date
2017-09-06, 1396/06/15
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.60
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
Self-efficacy
Timepoint
Before intervention, After intervention
Method of measurement
The Diabetes Management Self-efficacy Scale (DMSES)
2
Description
Hemoglobin A1c
Timepoint
Before and after the intervention
Method of measurement
Blood-test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group includes routine medicine treatment that depends on Endocrinologist diagnosis and receiving Acceptance and Commitment Therapy in eight 90- minutes sessions for two months.
Category
Behavior
2
Description
Control group: control group includes routine medicine treatment that depends on Endocrinologist diagnosis without psychotherapy .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid beheshti hospital
Full name of responsible person
mozafari
Street address
Ravand Blv
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
kashan university of medical science, ghotbe ravandi blv, Kashan
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 9111
Email
f99n99@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Nasiri
Position
MSc student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 9111
Email
f99n99@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Nasiri
Position
MSc student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 9111
Email
f99n99@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Nasiri
Position
MSc student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 9111
Email
f99n99@yahoo.com
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
All information about questionnaires and tests is available
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers who works in academic institutions and university
Under which criteria data/document could be used
If data is only intended to facilitate another research work, and the use of this information alone is not permissible in other articles.