1- Determining the effectiveness of acceptance-based emotion regulation group therapy on diabetes scale.
Design
present randomized clinical trial is semi-experimental and includes three stages: pre-test, post-test and follow-up with equivalent control groups. 60 people with type 2 diabetes were selected and randomly divided into three groups.
Settings and conduct
The study started with 60 patients who were divided into three intervention and control groups by random replacement method:
Treatment sessions for each of the intervention groups were provided on two separate occasions so that the number of people in the groups was 10 people. Thus, there were 4 intervention groups in this research. Treatment sessions for people who were on the waiting list were held after the end of the follow-up.
Also, the follow-up phase was implemented 6 months after the last group therapy session, and the group members completed the questionnaires of this phase and performed their blood sugar test.
Participants/Inclusion and exclusion criteria
inclusion:
1) diagnosis of type 2 diabetes by an endocrinologist and metabolism specialist,
2) age range of 35 to 65 years,
3) treatment under the supervision of a doctor with endocrine and metabolism expertise,
4) Having a medical record under the supervision of an endocrinology and metabolism specialist,
Intervention groups
Acceptance based emotion regulation
Acceptance and commitment group
Treatment as usual group
Main outcome variables
The outcome variables of the research are diabetes control scales, which include self-care, quality of life, and glycosylated hemoglobin(HbA1c).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230401057794N1
Registration date:2023-04-21, 1402/02/01
Registration timing:retrospective
Last update:2023-04-21, 1402/02/01
Update count:0
Registration date
2023-04-21, 1402/02/01
Registrant information
Name
Elnaz Hajati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2251 4091
Email address
elnazhajati@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2019-10-23, 1398/08/01
Actual recruitment end date
2019-12-22, 1398/10/01
Trial completion date
2020-03-10, 1398/12/20
Scientific title
Effectiveness of acceptance based emotion regulation on diabetes control scale on type 2 diabetes.
Public title
Psychotherapy on diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis if type 2 diabetes by endocrinologist
Age between 35-65
Treatment under endocrinologist
Medical report
Exclusion criteria:
New drug treatment with the start of intervention
Not suffering from other type of diabetes
Sever psychiatric disorder
Substance abuse disorder
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method of the current research is restricted randomization, and random allocation rule is used to select people in the intervention groups. At first, codes were assigned to all three groups, and then by lottery, the order of the groups was determined in order of acceptance based emotion regulation, acceptance and commitment, and the waiting list. In the next step, the code was assigned to the sample people. Then each code was drawn by lottery and assigned to the groups based on the order they were placed until the codes were finished. 20 people were in the acceptance based emotion regulation group, 20 people were in the acceptance and commitment group, and 20 people were in the waiting list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
خیر
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee if iran university
Street address
satarkhan
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-10-16, 1398/07/24
Ethics committee reference number
IR.IUMS.REC.1398.760
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11.6
ICD-10 code description
Type 2 diabetes mellitus with other specified complications
Primary outcomes
1
Description
Quality of life
Timepoint
Pre test, post test, follow up
Method of measurement
The adult of diabetes-dependent quality of life
2
Description
Self-care
Timepoint
Pre test, post test, follow up
Method of measurement
Summary of diabetes self-care activities
3
Description
HbA1c
Timepoint
Pre test, post test, follow up
Method of measurement
Blood Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The acceptance based emotion regulation The therapeutic intervention takes place during 14 sessions, and during these sessions, the role of emotions, their function, how to identify and properly express them, strategies for regulating unpleasant emotions and the role of values in giving meaning to life conditions are discussed. Each session is held once a week for 1:30. The people present in this intervention sit around each other in a room and the therapist, after introducing and teaching the points of the session, leads them to joint discussion and group exercises. The content of each session is prepared with the help of educational aids such as PowerPoint and session summaries and is provided to them.
Category
Treatment - Other
2
Description
Control group 1: acceptance and commitment group/ The therapeutic intervention takes place during 12 sessions and during these sessions the role of values, adherence to them and acceptance of inevitable aspects of life are discussed. The content of each session is detailed in the protocol of this treatment. Each session is held once a week for 1:30. The people present in this intervention sit around each other in a room and the therapist, after introducing and teaching the points of the session, leads them to joint discussion and group exercises. The content of each session is prepared with the help of educational aids such as PowerPoint and session summaries and is provided to them.
Category
Treatment - Other
3
Description
Control group 2: Treatment as usual/This group receive drug treatment and routine education of the Diabetes Association.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian diabetes association
Full name of responsible person
Dr.Rajab
Street address
Satarkhan
City
Tehran
Province
Tehran
Postal code
123345555
Phone
+98 21 8824 8124
Fax
Email
iraniandiabetessociety@yahoo.com
Web page address
http://diabeteshom.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Banafshe Gharaee
Street address
Satarkhan
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir
Web page address
http://iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Banafshe Gharraee
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Satarkhan
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
b.gharraee@gmail.com
Web page address
http://iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Banafshe Gharraee
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Satarkhan
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
b.gharraee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Banafshe Gharraee
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Satarkhan
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
b.gharraee@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Main result
When the data will become available and for how long
6 month after publication
To whom data/document is available
University
Under which criteria data/document could be used
For research
From where data/document is obtainable
elnazhajati@yahoo.com
What processes are involved for a request to access data/document