The objective of this clinical trial is to investigate the effect of cognitive behavioral group therapy on anxiety and depression of hemodialysis patients. In this study, 36 patients who meet the inclusion and exclusion criteria will be recruited and randomly assigned into intervention or control group. The patients in the intervention group will receive cognitive behavioral group therapy for 12 sessions. The patients in the control group will not receive any intervention. After the intervention, intensity of anxiety and depression will be measured and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109177573N1
Registration date:2011-11-07, 1390/08/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-07, 1390/08/16
Registrant information
Name
Zahra Sepehrmanesh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1444 3025
Email address
ahmadvand-a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Akhavan Hospital
Expected recruitment start date
2008-01-20, 1386/10/30
Expected recruitment end date
2008-04-20, 1387/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of grouptherapy on anxiety and depression of dialysis patients
Public title
Effect of group therapy in dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-45 years, having an education level at least as primary school, score of 8 and more in Beck anxiety interview and score of 16 and more in Beck depression interview
Exclusion criteria: presence of severe medical problem
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
18
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
Kashan University of Medical Sciences
Street address
Kashan
City
Kashan
Postal code
Approval date
2008-11-02, 1387/08/12
Ethics committee reference number
29/5/1/3247
Health conditions studied
1
Description of health condition studied
Anxiety and depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Intensity of depression
Timepoint
before and after intervention
Method of measurement
Beck depression test
2
Description
Intensity of anxiety
Timepoint
Before and after intervention
Method of measurement
anxiety test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention includes cognitive becavioral group therapy in 12 section , each section last for 60 to 90 minutes. these sections carried out by clinical psychologist and nurse. Sections of grouptherapy includes ; section 1:Group members were introduced and was explained rules . Section 2 and 3 : needs and problems of patients was declared and answered to them such as illness and its consequences and drugs .
in the next sections(4-12) grouptherapist ( psychologist )explain these issues 1) our feelings are made by our thoughts. 2) train thoughts analysing to patients. 3) train finding of problematic thoughts 4-5)chang of incorrect thoughts .6) education of relaxtion in end of each section .7-8-9 ) train of self-punishment and self-admiration10-11-12) train logical analysis and imagination method.
Category
Rehabilitation
2
Description
control group recieved no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Hospital
Full name of responsible person
Zahra Sepehrmanesh
Street address
Akhavan Hospital, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Akhavan Hospital
Full name of responsible person
Zahra Sepehrmanesh
Street address
Akhavan Hospital
City
Kashan
Grant name
000
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Akhavan Hospital
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
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sepehrmanesh
Position
Assistant Professor
Other areas of specialty/work
Street address
Akhavan Hospital
City
Kashan
Postal code
00983614443025
Phone
+98 36 1444 3025
Fax
+98 36 1444 1515
Email
z.sepehrmanesh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sepehrmanesh
Position
Assistant Professor
Other areas of specialty/work
Street address
Akhavan hospital
City
Kashan
Postal code
8713783981
Phone
+98 36 1444 3025
Fax
+98 36 1444 1515
Email
z.sepehrmanesh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Afshin Ahmadvand
Position
Assistant Professore
Other areas of specialty/work
Street address
Akhavan Hospital
City
Kashan
Postal code
Phone
+98 36 1444 3025
Fax
+98 36 1444 1515
Email
psychiatric.department@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)