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The effect of Cognitive behavior group training on HbA1C self efficacy, depression, illness perception and quality of life in patient with diabetes type II

Protocol summary

Summary
The aim of current study is the effect of Cognitive-behavioral group training on HbA1c (glycosylated hemoglobin), self-efficacy, depression, illness perception and quality of life on patients with type II diabetes .This study is a pretest- post test study with control group.The sample consisted of 30 patients with diabetes type II from 4000 diabetes population with file in sari. they will dividing randomly into 15 people in control and experimental groups. The main inclusion criteria are:1) type II diabetes patients with file 2) live in Sari,3) patients eligible criteria of Major depressive disorder 4)patients Having at least a high school diploma 5) age of patients between 20-55 years old.The main exclusion criteria are: Non-use of psychiatric antidepressant medications during the intervention. The experimental group receive 10 sessions of cognitive-behavioral training with Beck approach with 1.5 hours duration two times a week.The control group did not receive any intervention.In both control and experimental groups before the intervention, HbA1c testing will done and by all patients, the Beck Depression Inventory, diabetic self-efficacy, illness perception, diabetic quality of life will filled. In the follow-up, immediately after the intervention and one month later questionnaires will complete by patients but HbA1c testing will done only a month after the intervention. The primary outcomes of the study will include HbA1c and 4 psychological variables of, diabetic self-efficacy depression,illness perception and quality of life .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021832637N1
Registration date: 2017-05-12, 1396/02/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-12, 1396/02/22
Registrant information
Name
Mohammad Ali Barzegar Damadi
Name of organization / entity
Islamic Azad University - Sari Branch
Country
Iran (Islamic Republic of)
Phone
+98 11 4204 4744
Email address
mbarzegar2020@gmail.com
Recruitment status
Recruitment complete
Funding source
with first writer MOHAMMAD ALI BARZEGAR DAMADI . 00989111241563
Expected recruitment start date
2012-04-29, 1391/02/10
Expected recruitment end date
2012-07-30, 1391/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cognitive behavior group training on HbA1C self efficacy, depression, illness perception and quality of life in patient with diabetes type II
Public title
Effect of cognitive behavior therapy on HbA1c and psychological factor on patient with diabetic type 2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients have diabetes type II; at least a diploma ; resident of Sari city; HbA1C between 6.5 – 8 % FBS ≥ 126 mg/dl , 2hrpp ≥ 180 mg / dl ; patients have depression disorder ٍExclusion criteria: Patients who received antidepressants.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
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
IAU- AZAD University
Street address
sari sea road
City
sari
Postal code
48164194
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.IAU.SARI.REC.1395.12

Health conditions studied

1

Description of health condition studied
Diabetes type 2 - Depression
ICD-10 code
E11,F32
ICD-10 code description
Non-insulin-dependent diabetes mellitus,Depressive episode

Primary outcomes

1

Description
HbA1c
Timepoint
pretest-posttest control group
Method of measurement
in medical lab with Nicocard kit

2

Description
Depression
Timepoint
pretest-posttest control group and one month follow-up.
Method of measurement
Beck depression Inventory

3

Description
Self- efficacy
Timepoint
pretest-posttest control group and one month follow-up.
Method of measurement
DMSES questionnaire

4

Description
Quality Of life
Timepoint
pretest-posttest control group and one month follow-up.
Method of measurement
D39 questionnaire

5

Description
Illness Perception
Timepoint
pretest-posttest control group and one month follow-up.
Method of measurement
IPQ questionnaire

Secondary outcomes

1

Description
without secondary measure
Timepoint
none
Method of measurement
none

Intervention groups

1

Description
Type of intervention: Cognitive- Behavioral group training ,5 weeks ,10 sessions, two days a week ,duration 1.5 hours/ Sessions
Category
Other

2

Description
The control group does not receive any treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hospital - Diabetes clinic
Full name of responsible person
Miss Akbardokht
Street address
Mostafavian Clinic Emam Hospital Sari
City
Sari

2

Recruitment center
Name of recruitment center
Dr akha MD- clinic
Full name of responsible person
Miss Doctor Akha MD
Street address
Gharan Street Sari
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University - Sari Branch
Full name of responsible person
Mohammad Farsi
Street address
Sea Road Kilometer 7
City
SARI
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University - Sari Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
with me corresponding writter
Full name of responsible person
mohammad ali barzegar damadi
Position
clinical psychologist MA
Other areas of specialty/work
Street address
sari
City
sari
Postal code
Phone
+98 11 4204 4744
Fax
Email
mbarzegar2020@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
IAU
Full name of responsible person
Bahram mirzaian
Position
General psychologist PHD
Other areas of specialty/work
Street address
Sea Road Kilometer 7
City
SARI
Postal code
Phone
+98 11 3325 9528
Fax
Email
bahrammirzaian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
this research is a thesis for Master degree in IAU in sari
Full name of responsible person
mohammad ali barzegar damadi
Position
clinical psychologist MA
Other areas of specialty/work
Street address
City
sari
Postal code
Phone
Fax
Email
mbarzegar2020@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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