This study compared the effects of psychological training with citalopram drug for reducing symptoms of anxiety and depression in dialysis patients. 60 hemodialysis patients with the hospital anxiety depression scale score greater or equal to eight randomly divided into two groups and one group received a three-hour session teaching about anatomy and physiopathology of kidney, all kinds of treatments for renal failure, dialysis operation mechanism, the necessary care in dialysis patients, stage adaptive response in humans and problem solving training, stress management training and muscle relaxation. The other group treated with citalopram 20 mg a day. Again after six weeks, hospital anxiety and depression scale scores in both groups were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105012898N2
Registration date:2011-05-28, 1390/03/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-28, 1390/03/07
Registrant information
Name
Seyed Hamzeh Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3337 3844
Email address
shhosseini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-12-22, 1388/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
psychoeducation VS citalopram on depression and anxiety symptoms reduction among dialysis patients
Public title
psychoeducation VS citalopram on depression and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with renal disease that diagnosed by Nephrology specialist and treated by dialysis; Depression or anxiety HADS score ≥8
Exclusion criteria:
The new stressful events during the study period, according to Holmes-Rahe table stressful events; Any change in the dialysis program; Beginning of any other psychiatric treatment during the study; Known history of previous psychiatric disorder; 5- Having new stressors during the past six months other than renal disease; 6- Lack of participation in all educational sessions
Age
From 18 years old to 65 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran university of medical sciences
Street address
Moallem square
City
Sari
Postal code
Approval date
2009-04-16, 1388/01/27
Ethics committee reference number
88-45
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Organic anxiety disorder
2
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
HADS anxiety score
Timepoint
6 week
Method of measurement
Questionnaire
2
Description
HADS depression score
Timepoint
6 week
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Citalopram (20 mg for 6 week)
Category
Treatment - Drugs
2
Description
3 one hour psychological session
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hospital
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran university of medical sciences
Full name of responsible person
Dr Ahmad ALI Enayati
Street address
Deputy of research and thechnology of Mazandaran university of medical sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran university of medical sciences
Full name of responsible person
Hamzeh Hesseini
Position
Psychiatrist
Other areas of specialty/work
Street address
Emam Hospital
City
Sari
Postal code
Phone
+98 911 124 2487
Fax
Email
shhosseini@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran university of medical sciences
Full name of responsible person
Hamzeh Hosseini
Position
Associate
Other areas of specialty/work
Street address
Emam Hospital
City
Sari
Postal code
Phone
+98 911 124 2487
Fax
Email
shhosseini@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran university of medical sciences
Full name of responsible person
seyed hamzeh hosseini
Position
Other areas of specialty/work
Street address
City
sari
Postal code
Phone
Fax
Email
shhosseni@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)