Developing the integrated Package of compassion focused therapy with acceptance and commitment Therapy and Comparison its effectiveness with cognitive behavioral therapy on depression, Psychological Well-being, interpersonal forgiveness and HbAIC in Female Patients with Type II diabetes.
The purpose of this study is :The effetiveness of acceptance and commitment therapy and compassion focused therapy on depression of diabetic females.
Design
Semi experimental method with 3 experimental groups and 1 control group were assigned randomly.
Settings and conduct
Shahid Shabani diabetic center _ 61 diabetic females in 3 experimental groups and 1 control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria : patient's tendency to participate in the study and obtaining informed consent from them , being able to read and write (having literacy), age range 30 - 60 years old and being female. Exclusion criteria : refraining from participation in the research and absence from more than 3 sessions in the group therapy.
Intervention groups
"Intervention group 1" ( ACT group - compassion focused }
"Interventoion group 2" ( CFT group - ACT focused }
"Intervention group 3" ( CBT group ) and Control group.
Main outcome variables
Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180607039996N1
Registration date:2018-12-10, 1397/09/19
Registration timing:retrospective
Last update:2018-12-10, 1397/09/19
Update count:0
Registration date
2018-12-10, 1397/09/19
Registrant information
Name
Shahin Khayatan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3264 1704
Email address
shahin.khayatan@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-24, 1396/03/03
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing the integrated Package of compassion focused therapy with acceptance and commitment Therapy and Comparison its effectiveness with cognitive behavioral therapy on depression, Psychological Well-being, interpersonal forgiveness and HbAIC in Female Patients with Type II diabetes.
Public title
Developing the integrated Package of compassion focused therapy with acceptance and commitment Therapy and Comparison its effectiveness with cognitive behavioral therapy on depression, Psychological Well-being, interpersonal forgiveness and HbAIC in Female Patients with Type II diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining informed consent.
The age range of 30 - 60 years old.
Female patients.
Exclusion criteria:
Refraining from participation in the research.
Absence from more than 3 sessions.
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
61 subjects were randomly ( through lottery ) assigned to 3 experimental groups and 1 control group. Referring to Shahid Shabani diabetic center in Isfahan, 61 diabetic females who were referring to this center for treatment were purposefully selected for research, and after obtaining informed consents from them, were assigned randomly in four groups including three experimental groups and one control group.
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
IR.IAU.KHUISF.REC.
Street address
Moshtagh-hamze-lane4-12
City
Isfahan
Province
Isfehan
Postal code
8158835441
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.037
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08.0
ICD-10 code description
Diabetes mellitus due to underlying condition with hyperosmolarity
Primary outcomes
1
Description
Depression
Timepoint
Pre-test post _test follow up
Method of measurement
Beck depression inventory
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group 1": { CFT group - ACT focused }
Category
Treatment - Other
2
Description
"Intervention group 2 ": { ACT group - CFT focused }
Category
Treatment - Other
3
Description
'Intervention group 3 ": { CBT group }
Category
Treatment - Other
4
Description
Control group: control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Shabani diabetic center
Full name of responsible person
DR. Roya Zolfaghari
Street address
Charbagh Street
City
Isfshsn
Province
Isfehan
Postal code
8158835441
Phone
+98 31 3265 7960
Email
AMOOZESHTAMIN@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reseacher:Shahin Khayatan
Street address
Isfahan، Arghavanie Street، Islamic Azad University (Isfahan) Branch
City
Isfahan
Province
Isfehan
Postal code
81595158
Phone
+98 31 3535 4001
Email
shahin.khayatan@khuisf.ac.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
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
2
Sponsor
Name of organization / entity
َََ Islamic Azad University،Isfahan (Khorasgan)Branch
Full name of responsible person
Shahin Khayatan
Street address
isfahan،moshtagh،lane 4 ،12
City
Isfahan
Province
Isfehan
Postal code
8158835441
Phone
+98 31 3264 1704
Email
shahin.khayatan@khuisf.ac.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،Isfahan (Khorasgan)Branch