Protocol summary

Summary
The goal of this study is the effect of cognitive behavioral stress management on quality of life in patients with psychosomatic disorder refers to the Isfahan psychiatry clinic in 2013. This study is randomized control trail and has two groups. every groups are 35 persons.we have 8 sessions weekly for intervention group. we give an audio CD to control group after intervention.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2014071418481N1
Registration date: 2014-11-04, 1393/08/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-04, 1393/08/13
Registrant information
Name
Esmat Rahimi
Name of organization / entity
Isfahan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3441 7223
Email address
rahimiesmat44@yahoo.com
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2014-05-08, 1393/02/18
Expected recruitment end date
2014-09-11, 1393/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive behavioral stress management on quality of life in patients with psychosomatic disorder refers to the Isfahan psychiatry clinic in 2013.
Public title
The effect of stress management on quality of life in patients psychosomatic disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria; Age up 18; Don't have any sever mental disease like schizophrenia and MDD; Don't have substance abuse Exclusion criteria; Absent up 2 session; Don't want stay at study
Age
From 18 years old to 139 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Isfahan University of Medical Sciences
Street address
Nursing midwifery school; Isfahan University of Medical Science; Hezar garib St; Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2004-05-06, 1383/02/17
Ethics committee reference number
393158

Health conditions studied

1

Description of health condition studied
psychsomatic disorders
ICD-10 code
F54
ICD-10 code description
Psychological and behavioural factors associated with disorders or diseases classified elsewhere

Primary outcomes

1

Description
quality of life
Timepoint
pre- 2 monthes after and 1 month fallowing end of program
Method of measurement
sf-36 questioner

Secondary outcomes

1

Description
Quality of life and its 8 dimens
Timepoint
pre- 2 monthes fter and 1 month after fallowing program
Method of measurement
SF36 score

Intervention groups

1

Description
For intervention group 8 session weekly cognitive behavioral stress management
Category
Lifestyle

2

Description
For control group after filled the questioner; will give them a book about psychosomatic disorders and audio CD
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Psychological Clinic
Full name of responsible person
Hamid Afshar Zanjani
Street address
Isfahan Psychological Clinic; Shariati St; Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ashraf Kazemi
Street address
Isfahan University of Medical Sciences; Hezar jarib ST; Isfahan
City
Isfahan
Grant name
393158
Grant code / Reference number
393158
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Isfahan University of Medical Science
Full name of responsible person
Fariba Taleghani
Position
nursing PHD
Other areas of specialty/work
Street address
nusing midwifery school; Isfahan University of Medical Science; Hezar garib St; Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2901
Fax
-
Email
webmaster@nm.mui.ac.ir
Web page address
http:/nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Mohsen Yazdani
Position
Master
Other areas of specialty/work
Street address
Nursing and Midwifery School; Isfahan University of Medical Scien;ce; Hezar garib St; Isfahan
City
Isfahan
Postal code
-
Phone
+98 31 3792 2960
Fax
-
Email
mohsen_yazdani@nm.mui.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Yazdani
Position
Masters of degree
Other areas of specialty/work
Street address
nursing midwifery school; Isfahan University of Medical sciences; Hezar garib St; Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2960
Fax
-
Email
mohsen_yazdani@nm.mui.ac.ir
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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