The aim of this study was to investigate the effect of psychoeducation on depression and anxiety symptoms among dialysis patients. A total of 60 hemodialysis patients with the depression or anxiety HADS score ≥8 were assigned into investigation and waiting groups, after matching for the important risk factors (sex, marital status, educational level, time and frequency of dialysis). Three an-hour sessions about the kidney anatomy and physiopathology, treatments of ESRD, the mechanism of dialysis, adjustment steps in human, problem solving, stress management and relaxation training were held for the investigation group. The HADS inventory was completed for both group before and a week after the educational session.
General information
Acronym
non
IRCT registration information
IRCT registration number:IRCT138805282353N1
Registration date:2012-05-17, 1391/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-17, 1391/02/28
Registrant information
Name
Arefeh Bigom Shafaat
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 2955
Email address
ashafaat@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2008-07-22, 1387/05/01
Expected recruitment end date
2010-01-20, 1388/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of psychoeducation on depression and anxiety symptoms among dialysis patients
Public title
Effect of psychoeducation on depression and anxiety symptoms among dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: depression or anxiety scores greater or equal to 8 scale HADS
patients with renal failure being treated with hemodialysis
Exclusion criteria: 1. Experiencing new stressful events during the time of study based on Holmz-Rahe list of stressful life events
2. Any change in the dialysis schedule
3. Starting any other psychiatric treatment during the period of study
4. A known history of previous psychiatric disorder
5. Having a new stressor during previous 6 months except for those related to kidney disease
6. Failure to attend in all educational sessions
Age
No age limit
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
non
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for Research of Mazandaran University of Medical Sciences and Health Services
Street address
Moallem square
City
Sari
Postal code
Approval date
2008-06-23, 1387/04/03
Ethics committee reference number
24-85
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
F33
ICD-10 code description
Recurrent depressive disorder
Primary outcomes
1
Description
Depression
Timepoint
before and 1 week after intervention
Method of measurement
HADS Questionnaire
2
Description
Anxiety
Timepoint
before and 1 week after intervention
Method of measurement
HADS Questionnaire
Secondary outcomes
1
Description
non
Timepoint
non
Method of measurement
non
Intervention groups
1
Description
Three an-hour group education, by a nephrologist and psychiatrist. Content of educational sessions include: 1. Describing the anatomy and pathophysiology, all causes of kidney failure, the advantages and disadvantages of various treatments for renal failure, mechanism of function of dialysis, care needed in dialysis patients, 2. The adaptive response in human learning and problem solving skills 3. Stress management training and muscle relaxation
Category
Behavior
2
Description
psychoeducation
Category
Other
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
Moallem Square
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 Hosseini
Position
Associste professor
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
Associated professor
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
arefeh shafaat
Position
Assistant professor
Other areas of specialty/work
Street address
Zare hospital
City
Sari
Postal code
4843185774
Phone
+98 32 85109
Fax
Email
arefeh_shafaat@YAHOO.COMashafaat@mazum.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)