Protocol summary

Summary
The most common metabolic disorder is diabetes mellitus. Depression is one of the psychological disorders commonly accompanying diabetes.The objective of this randomized, double blind trial is to investigate the effect of cognitive behavior therapy on depression of diabetic patients refereed to diabetic clinic affiliated to Shiraz University of Medical Sciences in 2009. In this study 60 patients with required criteria were divided into two groups based on the convenience sampling method, using random block allocation. 30 patients in control group and 30 patients in experimental group. The experimental group was randomly divided into three groups of 10 and received 8 sessions of cognitive-behavior therapy. The level of depression was checked before,two weeks, four weeks, and two months after intervention in both groups. Blood glucose (glycosylated hemoglob in) was also checked before and two months after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110012812N4
Registration date: 2012-03-29, 1391/01/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-29, 1391/01/10
Registrant information
Name
Farkhondeh Sharif
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1212 2401
Email address
fsharif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2009-04-03, 1388/01/14
Expected recruitment end date
2009-10-23, 1388/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive group therapy on depression of diabetic patients referred to diabetic clinic affiliated to Shiraz University of Medical Sciences-2009
Public title
The effect of cognitive group therapy on depression of diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were as follows: willing to participate in the study, suffering from diabetes type 2 and not having major depression according to DSM-IV criteria, having a history of diabetes for more than one year, no background of committing suicide, mental disorder, or drug abuse.exclusion criteria were absence of more than 3 sessions and consuming psychiatric drugs. psychotherapeutic medication.
Age
From 18 years old to 70 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
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study 60 patients with required criteria were divided into two groups based on the convenience sampling method, using random block allocation.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street,central Building
City
Shiraz
Postal code
71345-1359
Approval date
2009-06-22, 1388/04/01
Ethics committee reference number
CT88-4714

Health conditions studied

1

Description of health condition studied
Dibetic Mellitus
ICD-10 code
E10-14
ICD-10 code description
Endocrine, nutritional and metabolic diseases

Primary outcomes

1

Description
Depression
Timepoint
Before the Intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group attended eight sessions of cognitive behavior therapy.each session lasting for 1.5 hour.
Category
Behavior

2

Description
Control Group received only the routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Mottahari Clinic
Full name of responsible person
Farkhondeh Sharif
Street address
Zand street, Shiraz University of Medical Sciences
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Vice chancellor for research
Full name of responsible person
DrGholamreza Hatam
Street address
Shiraz University of Medical Sciences,University Central Building,Zand street, beside red cross
City
Shiraz
Grant name
Grant code / Reference number
CT88-4714
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Vice chancellor for research
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
Shiraz University of Medical Sciences,
Full name of responsible person
Dr Hatam
Position
vICE CHANCELLOR FOR RESEARCH
Other areas of specialty/work
Street address
7th floor, Shiraz University of Medical Sciences, Zand street.
City
Shiraz
Postal code
71347-1359
Phone
+98 71 1230 5410
Fax
Email
research@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farkhondeh sharif
Position
Ph.D
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Central Building,Zand street
City
Shiraz
Postal code
71345-1359
Phone
+98 71 1823 9725
Fax
+98 71 1647 4252
Email
fsharif@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for updating data

Contact

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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