The Effectiveness of the Therapeutic Life-based Appearance Package Based on Adoption Therapy and the Special Therapeutic Commitment of Female Patients with Type 2 Diabetes and Its Comparative Effect with Mindfulness-Based Cognitive Therapy, Self-Care, Resilience, Depression, Adherence to Treatment, and Glycosylated Hemoglobin
The purpose of this study was to investigate the effect of the package of lifestyle-based health on the basis of treatment and acceptance and to compare the effect of this package with cognitive therapy on mind-awareness on self-care, resilience, depression, tolerance to treatment and glycosylated hemoglobin in women with type II diabetes Isfahan city. The intervention stage was a semi-experimental, pre-test, post-test, and follow-up period with a control group.
Design
Clinical trials with community based and pragmatic control group with parallel, blind, randomized groups
Settings and conduct
The efficacy of a phenomenal package of lifestyle based on the treatment of admission and special commitment of patients with type 2 diabetes and its comparison with cognitive therapy based on mind-awareness, the statistical population of women with type 2 diabetes in Isfahan and at a medical charity center
Participants/Inclusion and exclusion criteria
Women with type 2 diabetes
Intervention groups
Group 1: Health Lifestyle Intervene with Acceptance and Commitment, Group 2: Intervention of Cognitive Therapy Based on Mindfulness, Group III: Group on the waiting list of treatment and currently do not receive interventional control group.
Main outcome variables
depression, self-care, resilience, adherence to treatment and glycated hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180522039786N1
Registration date:2018-08-27, 1397/06/05
Registration timing:retrospective
Last update:2018-08-27, 1397/06/05
Update count:0
Registration date
2018-08-27, 1397/06/05
Registrant information
Name
Maryam Hor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3338 4716
Email address
marya.hor@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-06, 1397/03/16
Expected recruitment end date
2018-08-19, 1397/05/28
Actual recruitment start date
2018-06-05, 1397/03/15
Actual recruitment end date
2018-08-19, 1397/05/28
Trial completion date
empty
Scientific title
The Effectiveness of the Therapeutic Life-based Appearance Package Based on Adoption Therapy and the Special Therapeutic Commitment of Female Patients with Type 2 Diabetes and Its Comparative Effect with Mindfulness-Based Cognitive Therapy, Self-Care, Resilience, Depression, Adherence to Treatment, and Glycosylated Hemoglobin
Public title
Preparing a phenomenological package for Healthy Life Style Treatment Based on Acceptance and Combination and Compare the Effect of Its Combination with Mindfulness Based on Cognitive Therapy on Self-care,Ressilience,Depression,Adherence to Treatment & Glycated Hemoglobin
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent,.
,Definite diagnosis of type 2 diabetes is at least one year old,
Age range between 35 and 69 years
Medium to severe depression score and low or moderate score in resilience
Access to patients and their lack of participation in other research projects simultaneously
Exclusion criteria:
Having acute psychiatric disorder based on clinical interview,
Age
From 35 years old to 69 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
15
Woman with type 2 diabetes
Actual sample size reached:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Islamic Azad University,Isfahan(khorasgan)Branch
Street address
Islamic Azad University, Isfahan (Khorasgan) branch, Arqavanieh, Jay Street, Isfahan, Iran. Box: 81595-158
City
Isfahan
Province
Isfehan
Postal code
158-81595
Approval date
2018-04-13, 1397/01/24
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.014
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
7
ICD-10 code description
E10-E14
Primary outcomes
1
Description
Depression score in Beck questionnaire is higher than 10,
Timepoint
Trimester
Method of measurement
. Back depression inventory (1961)
2
Description
Resonance increase based on Connor and Davidson questionnaire above 30
Timepoint
Trimester
Method of measurement
Resilience Conner inventory (2003)
3
Description
Increased self-care based on the scale of self-care activities of diabetic patients (SDSCA) above 4
Timepoint
Trimester
Method of measurement
Tobert self-care inventory (2000),
Secondary outcomes
1
Description
Glycosylated hemoglobin decreased by less than 6.5
Timepoint
Trimester
Method of measurement
Electrophoresis test in medical diagnostic laboratory
Intervention groups
1
Description
Intervention group: Life style health package based on acceptance and commitment
Category
Lifestyle
2
Description
Intervention group: MBCT
Category
Lifestyle
3
Description
Control group: 15 people without medical intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Charity Center for Training, Control, Prevention of Isfahan Diabetes
Full name of responsible person
Dr. Mohammad Ali Attari
Street address
street J, Lahore Street ،Isfahan,
City
Esfhan
Province
Isfehan
Postal code
158-81595
Phone
+98 31 1325 8444
Email
Diabetes_ngo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Majid Touhyani
Street address
Isfahan (Khorasgan) branch, Arqavanieh, Jay Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
158-81595
Phone
+98 31 1535 4001
Email
Marya.hor@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Hor
Position
Staff
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Isfahan (Khorasgan) branch, Arqavanieh, Jay Street, Isfahan, Iran
City
Isfhan
Province
Isfehan
Postal code
158-81595
Phone
+98 983115354001
Email
Marya.Hor@khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Hor
Position
Staff
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Isfahan (Khorasgan) branch, Arqavanieh, Jay Street, Isfahan, Iran
City
Isfhan
Province
Isfehan
Postal code
158-81595
Phone
+98 31 1535 4001
Email
MaryaHor@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Hor
Position
Staff
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Isfahan (Khorasgan) branch, Arqavanieh, Jay Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
158-81595
Phone
+98 31 1535 4001
Email
MaryaHor@khuisf.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
Part of the data can be shared after unidentifiable people
When the data will become available and for how long
2021
To whom data/document is available
For researchers, diabetes will be available at university institutes
Under which criteria data/document could be used
Use of any documentation is allowed for scholars.
From where data/document is obtainable
Maryam hor
Marya.hor@khuisf.ac.ir
What processes are involved for a request to access data/document
Posting emails and surveys will allow the submission of documentation.