Protocol summary

Summary
The aim of this study was to determine effect of coping skills training in decreasing stress of patients with epilepsy. Inclusion criteria were both male and female, age between 18-50 years and duration of illness more than 2years. Exclusion criteria were age under 18 and more than 50 years, and duration of illness below 2 years. Participants include 60 patients with epilepsy (30 patients as experimental and 30 persons as control group) were selected from Isfahan Epilepsy Association in 2010 in Isfahan, Iran. Coping skill therapy was carried out for experimental group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206107339N2
Registration date: 2012-11-02, 1391/08/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-02, 1391/08/12
Registrant information
Name
Amrollah Ebrahimi
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 8818
Email address
a_ebrahimi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Payam Noor University, Center Tehran, Iran
Expected recruitment start date
2011-06-02, 1390/03/12
Expected recruitment end date
2011-08-03, 1390/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of coping skills therapy on reduce of tension in patients with epilepsy
Public title
Effictiveness of stress coping training on tention of epileptic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-50 years; duration of illness more than 2 years; Persian language. Exclusion criteria: age under 18 and more than 50 years; duration of illness below 2 years; other language except Persian.
Age
From 18 years old to 50 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Payam Noor University, Center Tehran, Iran
Street address
Payam Noor University, Center Tehran,Karimkhan zand Street,Nejatallahi Avn.P233,Tehran, Iran
City
Tehran
Postal code
Approval date
2010-04-21, 1389/02/01
Ethics committee reference number
10552/1/د/100247

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
In typical depressive episodes of mild, moderate or severe, reducing patient's mood, energy, and a decrease in the activity . Capacity for enjoyment, interest, and concentration decreases. Fatigue is common, even after a few minutes of effort. Sleep is u

2

Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Two or three of the above symptoms are usually present. The patient is usually distressed by these but will probably be able to continue with most activities.

3

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is

4

Description of health condition studied
Mixed Depressin and Anxiety
ICD-10 code
F41.2
ICD-10 code description
This category should be used when symptoms of anxiety and depression are both present, but neither is clearly predominant, and neither type of symptom is present to the extent that justifies a diagnosis if considered separately. When both anxiety and depr

Primary outcomes

1

Description
severity of depressive symptoms
Timepoint
before ,after intervention
Method of measurement
Questionnares

2

Description
severity of anxiety symptoms
Timepoint
before ,after intervention
Method of measurement
Questionnares

3

Description
severity of stress-tention- symptoms
Timepoint
before ,after intervention
Method of measurement
Questionnares

Secondary outcomes

1

Description
coping strategies
Timepoint
after intervention
Method of measurement
Questionnare

2

Description
severity of tention
Timepoint
before after intervention
Method of measurement
Questionnare

Intervention groups

1

Description
In intervention group: stress coping training protocol is conducted.8 sessions per week (2 hrs) continue for two months
Category
Behavior

2

Description
The control group did not receive any therapy they were on the waiting list
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Association of Epilepsy
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
psychosomatic Research Center,Isfahan University of Medical Sciences
Full name of responsible person
Amrollah Ebrahimi
Street address
psychosomatic Research Center,Shariati,Street,Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
psychosomatic Research Center,Isfahan 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
psychosomatic Reacherch Center,Isfahan University of Medical Sciences,isfahan,Iran
Full name of responsible person
Amrollah Ebrahimi
Position
assistant professor/PhD
Other areas of specialty/work
Street address
Psychosomatic Reacherch Center, Shariati Street,Isfahan,Iran
City
Isfahan
Postal code
Phone
+98 31 1624 1081
Fax
Email
a_ebrahimi@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
psychosomatic Reacherch Center,Isfahan University of Medical Sciences,Isfahan,Iran
Full name of responsible person
Amrollah Ebrahimi
Position
Assistant Professor/phD
Other areas of specialty/work
Street address
psychosomatic Reacherch Center,Shariati Street,Isfahan,Iran
City
Isfahan
Postal code
Phone
+98 31 1625 8818
Fax
Email
a_ebrahimi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
psychosomatic Reacherch Center,IsfahanUniversity of Medical sciences ,Isfahan,Iran
Full name of responsible person
Amrollah Ebrahimi
Position
PhD/assistant professor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

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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