The comparison of the effectiveness of Acceptance and Commitment Therapy with the Lifestyle Intervention of promoting health on disease perception, disease adjustment, and HbA1c Levels in Type II Diabetes patients
The purpose of this study is to compare the efficacy of acceptance and commitment therapy with lifestyle intervention of promoting health in a sample of type II diabetes patients.
Design
60 type 2 diabetes patients who, after matching by age and gender, are divided to three groups,Two experimental and one control,will participate in the research
Settings and conduct
Diabetes and metabolic disorders specialty clinic
Participants/Inclusion and exclusion criteria
Sample persons are type II diabetes patients and should not have received psychological intervention since a year ago. People who can not participate in the study include those with type 1 diabetes or those who are
suffering from mental disorders, as well as those who have physical problems culminating in type 2 diabetes.
Intervention groups
In the research, the first group will have psychological treatment of acceptance and commitment. The second group has the lifestyle intervention of promoting health for type 2 diabetes patients. The third group is the control group.
Main outcome variables
Disease perception ;Disease adjustment ; Level of Hb A1C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039185N1
Registration date:2018-05-28, 1397/03/07
Registration timing:registered_while_recruiting
Last update:2018-05-28, 1397/03/07
Update count:0
Registration date
2018-05-28, 1397/03/07
Registrant information
Name
Nasim Soltanian
Name of organization / entity
Psychplogy and Education faculty of Semnan university
Country
Iran (Islamic Republic of)
Phone
+98 21 6161 1538
Email address
n.soltanian@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of Acceptance and Commitment Therapy with the Lifestyle Intervention of promoting health on disease perception, disease adjustment, and HbA1c Levels in Type II Diabetes patients
Public title
Effect of ACT on diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes patients
lack of getting psychological treatment since a year ago
Exclusion criteria:
Type 1 diabetes patients
Patients with Psychological disorders and Physical problems culminating in diabetes
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple random sampling. Having matched the samples in terms of age and gender, a number in the range of one to three will be given to evry group. Then the numbers randomly will be assigned to the title of evry group, like control group, ACT group and lifestyle group by a computeized program
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 Semnan University of Medical Science
Street address
Mahdishahr ;Education and psychology faculty of semnan university
City
Semnan
Province
Semnan
Postal code
3564111156
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.SEMUMS.REC.1396.257
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
Disease Perception
Timepoint
Before and after of Intervention
Method of measurement
The Brief Illness Perception Questionnaire (BIPQ)
2
Description
Disease adjustment
Timepoint
Before and after of Intervention
Method of measurement
Problem Areas in Diabetes Questionnaire(PAID)
3
Description
HbA1C
Timepoint
Before and after of Intervention
Method of measurement
Blood analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acceptance and commitment therapy (ACT). The name of ACT stemming from one of its main message: Accept what you can’t change and control it and commit to improve everything you can enrich and change it in your life. The purpose of ACT is attaining psychological flexibility. ACT has six core processes: Contacting the present moment; Defusion of thoughts; Acceptance; Values; Commitment and Self as a context. This protocol takes around two months to run. It has eight sessions. In fact the intervention aims at improving the quality of life of diabetes patients to cope with their disease toward having an active life. This program lays emphasis on medical issues along with psychological matters.
Category
Behavior
2
Description
Intervention group: Lifestyle intervention for promoting health. In fact this protocol is a medical approach for diabetes. It emphasizes on self-care behaviors like blood sugar tests, walking, mild exercise and diet. In this course patients will learn about risks and disease resulting from diabetes and will learn how to prevent them. This program comprises six sessions taking three weeks. This approach lays little emphasis on psychological variables.
Category
Lifestyle
3
Description
Control group: None intervention, only as evidence group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes and metabolic disorders speciality clinc
Full name of responsible person
Dr Fatemeh Bandarian
Street address
karegar-e-shomali Diabetes and metabolic disorders speciality clinic
City
Tehran
Province
Tehran
Postal code
1411715851
Phone
+98 21 8833 4192
Fax
Email
emri_diabetes@tumc.ac.ir
Web page address
http://emri.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of semnan- Psychology faculty
Full name of responsible person
Dr Eshagh Rahimian Bougar
Street address
Mahdishahr,Psychology faculty,Semnan University
City
Semnan
Province
Semnan
Postal code
356411156
Phone
+98 23 3362 4250
Email
psychology@semnan.ac.ir
Web page address
http://psy.semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
This is a PHD Dissertation
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
Faculty of Psychology and Education of Semnan university
Full name of responsible person
Nasim Soltanian
Position
PHD Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.4, 9 laleh, 35 metrieh laleh, Marzdaran blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1461874373
Phone
+98 21 4422 1959
Email
n.soltanian@semnan.ac.ir
Web page address
http://psy.semnan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Semnan
Full name of responsible person
Eshagh Rahimian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mahdishahr, Education and Psychology faculty of Semnan university
City
Semnan
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 4250
Email
i_rahimian@semnan.ac.ir
Web page address
http://psy.semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Semnan
Full name of responsible person
Nasim Soltanian
Position
PHD Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mahdishahr,semnan, Education and Psychology faculty of Semnan university
City
Semnan
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 4250
Email
n.soltanian@semnan.ac.ir
Web page address
http://psy.semnan.ac.ir
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
Not applicable
Title and more details about the data/document
Total research results will be published in scientific journals
When the data will become available and for how long
The documentation and research results are likely to be published in 2018-2019
To whom data/document is available
The full research document will be available to Semnan faculty of Psychology. Research results will be available to researchers as an article and book
Under which criteria data/document could be used
Using the results with the number and type of community and the research sample as well as the intervention can be used.
From where data/document is obtainable
Faculty of Psychology and Educational Sciences of Semnan University.
Information and Documentation Center of Iran (IranDoc)
Or sending a message to researcher : n.soltanian@semnan.ac.ir or n.soltanian@gmail.com
What processes are involved for a request to access data/document
Visiting the Irandoc center or Semnan University Library
Or one week after sending email to the writer