Protocol summary

Summary
The aim of the present study is to determine the impact of cognitive behavioral group therapy and family psycho-education alongside pharmacotherapy on symptoms of depressed patients. This is a clinical trial using convenience sampling method to randomly recruit 60 patients admitted with major depression from psychiatry patiants in Hajar Hospital Shahrekord . The patients were randomly allocated into three groups, each consisting of 20 patients. The first group underwent pharmacotherapy as well as cognitive behavioral group therapy. The second group received pharmacotherapy, cognitive behavioral group therapy and family psycho-education. The third group, which served as the control group, only received pharmacotherapy. Beck Depression Inventory II was applied to all three groups before and after therapeutic intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111298253N1
Registration date: 2012-01-24, 1390/11/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-24, 1390/11/04
Registrant information
Name
Sayed Kamal Solati
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38133338157
Email address
kamal_solati@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2010-11-11, 1389/08/20
Expected recruitment end date
2011-02-18, 1389/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of cognitive behavioral group therapy and family psycho-education and pharmacotherapy in improving symptoms of major depressive disorder women patients
Public title
Effect of psychological intervention on symptoms and preventing recurrence depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: - At least five criteria from the nine diagnostic criteria have been present during the two week period with DSM-IV - The presence of criteria above two weeks at least. - Female sex The minimum level of literacy in primary. - Participate of volunteered in the project. Exclusion criteria: - The presence of periods of manic and hypomanic states. - The presence of organic damage and cognitive dysfunctions such as dementia and mental retardation. - The presence of periods of delusion and hallucinations symptoms. -A history of receiving ECT.
Age
No age limit
Gender
Female
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
8815713471
Approval date
2011-08-02, 1390/05/11
Ethics committee reference number
89-9-9

Health conditions studied

1

Description of health condition studied
Major depression disorder
ICD-10 code
F33
ICD-10 code description
Recurrent Depressive Disorder

Primary outcomes

1

Description
Dypression symptoms
Timepoint
Before of intervention,After intervention,Follow-up
Method of measurement
Beck Depression Inventory -2

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cognitive - Behavior group therapy with drug therapy
Category
Behavior

2

Description
Control group: drug therapy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatry Ward ,Hajar Hospital .Parastar St.Shahrekord ,Iran
Full name of responsible person
Dr.Sayed Kamal Solati
Street address
Psychiatry Ward ,Hajar Hospital .Parastar St.Shahrekord ,Iran
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
ِDr.Sayed Kamal Solati
Street address
Psychiatry Ward ,Hajar Hospital .Parastar St.Shahrekord ,Iran
City
Shahrekord
Grant name
89-9-9
Grant code / Reference number
89-9-9
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences
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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Sayed kamal Solati
Position
PhD in Psychology - Assistant professor
Other areas of specialty/work
Street address
Psychiatry Ward,Hajar Hospital,Paraster St. Shahrekord,Iran
City
Shahrekord
Postal code
8815713471
Phone
+98 3813812220016
Fax
Email
kamal_solati@yahoo.com
Web page address
www.skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Sayed Kamal Solati
Position
PhD in Psychology - Assistant Professor
Other areas of specialty/work
Street address
Psychiatry Ward ,Hajar Hospital,Parastar St.Shahrekord,Iran
City
Shahrekord
Postal code
8815713471
Phone
+98 3813812220016
Fax
+98 3813812243715
Email
kamal_solati@yahoo.com
Web page address
www.skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Sayed Kamal Solati
Position
PhD in Psychology- Assistant Professor
Other areas of specialty/work
Street address
Psychiatry Ward.Hajar Hospital,Parastar St.Shahrekord,Iran
City
Shahrekord
Postal code
8815713471
Phone
+98 3813812220016
Fax
+98 3813812243715
Email
kamal_solati@yahoo.com
Web page address
www.skums.ac.ir

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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