Comparison of the Effectiveness of Compassionate Therapy and Positive Psychology with Well-being Approach on Alexithymia, Adaptive Behavior, Adherence of Treatment and Biological Factors in Patients with Diabetes Type2
The effectiveness of each treatment approach focused on CFT & positive psychology with the well being approach and comparing the effectiveness of these two approaches.
Design
clinical trial has control group, with parallel groups, single blind side, randomized, three groups of 15 people selected from 100 people, for choosing members have been used simple random selection.
Settings and conduct
Before COVID-19 Outbreak : two sections have been held in hospital, each section 2 hours a day.
After COVID-19 Outbreak and limitations : six sections have been held online.
Participants/Inclusion and exclusion criteria
Patients with type 2 diabetes for more than six months
High school education or more
Patient willingness and satisfaction to participate in research
30 years old or above
Intervention groups
there is 3 groups:
group 1. treatment with CFT
group 2. treatment with positive psychology and well being approach
group 3. control
Main outcome variables
The effectiveness and comparative effect of a separate treatment approach based on CFT and positive psychology onAlexithymia, Adaptive Behavior, Adherence of Treatment and Biological Factors in Patients with Diabetes Type2.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191023045222N1
Registration date:2020-06-12, 1399/03/23
Registration timing:retrospective
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Mahnaz Bahadori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 4091
Email address
p.askary@iauahvaz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-05-28, 1399/03/08
Actual recruitment start date
2020-05-21, 1399/03/01
Actual recruitment end date
2020-05-28, 1399/03/08
Trial completion date
2020-07-15, 1399/04/25
Scientific title
Comparison of the Effectiveness of Compassionate Therapy and Positive Psychology with Well-being Approach on Alexithymia, Adaptive Behavior, Adherence of Treatment and Biological Factors in Patients with Diabetes Type2
Public title
Comparison of the Effectiveness of Compassionate Therapy and Positive Psychology with Well-being Approach on Alexithymia, Adaptive Behavior, Adherence of Treatment and Biological Factors in Patients with Diabetes Type2
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes for more than six months
High school education or more
Patient willingness and satisfaction to participate in research
30 years old or above
Exclusion criteria:
Lack of mental disorder
type 1 diabetes
Gestational Diabetes
Diabetes is caused by other factors
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
By referring to the endocrinology department of Golestan Hospital, under the supervision of a specialist doctor who is my advisor in this research and by participating in the Great Diabetes Conference by preparing the consent form for participating in the course and demographic form and giving the necessary explanations, out of 500 people, 110 people announced their readiness. Then the names of the individuals were written one by one on the specific size sheets and the names were selected by lottery in the box.
Blinding (investigator's opinion)
Single blinded
Blinding description
Individuals were divided into three groups.
Apart from the control group, which did not intervene and only answered the questionnaires, the other two groups participated in educational-therapeutic classes, but without knowing in which aspect there was a change, effectiveness or effect.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Shahid chamran Blvd.
City
Hormozgan
Province
Hormozgan
Postal code
7916613885
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.HUMS.REC.1399.105
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
Alexithymia
Timepoint
It is before the intervention and 8 sessions later (two sessions per week)
Method of measurement
Toronto Alexithymia Scale
2
Description
Adaptive Behavior
Timepoint
It is before the intervention and 8 sessions later (two sessions per week)
Method of measurement
The Psychosocial Adjustment to Illness Scale (PAIS)
3
Description
Adherence of Treatment
Timepoint
It is before the intervention and 8 sessions later (two sessions per week)
Method of measurement
Modanloo adherence of treatment scale
Secondary outcomes
1
Description
mental health
Timepoint
After the intervention
Method of measurement
use Psycho-social Adjustment with Illness Scale
2
Description
Quality of Life
Timepoint
After the intervention
Method of measurement
use Modanlo Adherence of Treatment questionnaire
Intervention groups
1
Description
Intervention group 1: Compassionate Therapy group
Category
Treatment - Other
2
Description
Intervention group 2 : Positive psychology
Category
Treatment - Other
3
Description
Control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Leila Moradi
Street address
Farvardin Ave., Golestan Town.
City
َAhvaz
Province
Khouzestan
Postal code
6135733183
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
Golestanjpsital@yahoo.com
Web page address
https://hgolestan.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Rosta
Street address
Islamic azad university of Kish, Free Zone Organization Square, Sanaei Blvd, Kish
City
Kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Fax
+98 76 4442 3957
Email
Info@IaukishInt.Ac.Ir
Web page address
https://iaukish.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mahnaz Bahadori
Position
Family counselor & Teacher in Islamic Azad University of Ahvaz
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 142, Niloofar Ave, Newside
City
Ahvaz
Province
Khouzestan
Postal code
6173933481
Phone
+98 61 3443 4091
Email
m.bahadori96@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Mahnaz Mehrabizadeh Honarmand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No 338, Laleh Ave, Ostadan Town
City
Ahvaz
Province
Khouzestan
Postal code
6135713773
Phone
+98 912 604 9225
Email
m-mehrabizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Bahadori
Position
Family counselor & Teacher in Islamic Azad University of Ahvaz
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 142, Niloofar Ave, Newside
City
Ahvaz
Province
Khouzestan
Postal code
6173933481
Phone
+98 61 3443 4091
Email
m.bahadori96@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants' personal information will not be published, but data analysis is required in Chapter Four, as it relates to the PhD thesis.
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
Participant information was required for admission to psychotherapy, which we obtained after obtaining the consent form. This information is require in the demographic tables of chapters three and four of the thesis.
When the data will become available and for how long
After the dissertation has been defended then approved by the judges, it will be accessible.
To whom data/document is available
Colleges, professors , researchers and the people who are interested into science and research issues.
Under which criteria data/document could be used
1- For scientific experiments with license from related authorities.
2- Get the necessary permission from the supervisors, consultants and researchers of this research.
From where data/document is obtainable
1- Islamic Azad University, Kish International Branch.
2- After being indexed, it is available on more popular sites.
What processes are involved for a request to access data/document
Visit the Islamic Azad University, Kish International Branch's library and deliver the request to research unit.