The aim of this study was to compare the effect of combined cognitive behavior therapy with drug therapy and only drug therapy on the post-stroke depression. In this clinical trial, 28 women with post stroke depression were randomly assigned into intervention or control group. The intervention group received combined drug therapy and cognitive behavior therapy but the control group received only antidepressant drug. Intensity of depressive symptoms was measured by using Beck depression test and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008214607N1
Registration date:2010-10-10, 1389/07/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-10, 1389/07/18
Registrant information
Name
Mohammad Dehghani Firoozabadi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 0447
Email address
mdehghani@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2010-03-06, 1388/12/15
Expected recruitment end date
2010-06-05, 1389/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of effectiveness of combined cognitive behaviour and drug therapy and drug therapy on poststroke depression
Public title
Effectiveness of cognitive behaviour therapy on poststroke depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of post-stroke depression by neurologist and DSM IV-TR criteria, stroke clinical symptoms, findings of damage in brain CT scan or MRI
Exclusion criteria: severe motor or sensory deficit, aphasia, loss of consciousness
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
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
Islamic Azad University, Birjand Unit
Street address
Central Organization of Islamic Azad University, Ghaffari St.
City
Birjand
Postal code
9717813118
Approval date
2010-03-08, 1388/12/17
Ethics committee reference number
8550
Health conditions studied
1
Description of health condition studied
Depressive episode
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
poststroke depression
Timepoint
Before intervention, 8th week, end of intervention
Method of measurement
Beck depression test apply
Secondary outcomes
empty
Intervention groups
1
Description
Citalopram, tablet 20-80 mg daily, once daily, for three months
Category
Treatment - Drugs
2
Description
Citalopram, tablet 20-80 mg daily, once daily, for three months as well as Cognitive behaviour therapy included negative thoughts cognition and be conflict them, relaxation, pleasurable activity planning, 12 sessions one and half hour, one session per week, for three months
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital Special Clinic
Full name of responsible person
Dr. Mohammad Dehghani Firoozabadi
Street address
Emamreza Hospital, Taleghani St.
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr.Dehghani Mohammad
Street address
Birjan University of Medical Sciences, Ghaffari St.
City
Birjand
Grant name
---
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Full name of responsible person
Zahra Danaie Sij
Position
MS on clinical psychology
Other areas of specialty/work
Street address
Unit 3, Last home, Left side, End of Ghaffari 24, Ghaffari St.
City
Birjand
Postal code
9717944577
Phone
+98 56 1444 8962
Fax
+98 56 1444 0447
Email
mdehghani@bums.ac.ir mdehghani44@yahoo.com
Web page address
www.bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Dehghani Firoozabadi
Position
Neurologist
Other areas of specialty/work
Street address
University of Medical Sciences, Ghaffari St.
City
Birjand
Postal code
9717853577
Phone
+98 56 1444 0447
Fax
+98 56 1444 0447
Email
mdehghani@bums.ac.irmdehghani44@yahoo.com
Web page address
www.bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Dehghani Firoozabadi
Position
specialist/ Member of Scientific Board
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Postal code
9717853577
Phone
+98 56 1444 0447
Fax
+98 56 1444 0447
Email
mdehghani@bums.ac.irmdehghani44@yahoo.com
Web page address
www.bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)