Protocol summary

Summary
Aim:Cognitive behavioral stress management effects on depression, anxiety and pain control in patients with migraine headaches. We study all patients with migraine who refer to emam reza clinic and vali-asr hospital, Birjand, Iran. After being visited by neurologist, will examine through clinical interview and Beck depression and anxiety test; among them those of their scores is clinically significant, are treated with cognitive behavioral stress management. At the end of the intervention period, we retest Beck depression and anxiety test. Inclusion criteria: patients with migraine headache and patients with significant anxiety and depression test score. Exclusion criterion: lack of regular attendance in classes. Intervention: Holding 8 sessions Class 1/5 hour cognitive behavioral stress management

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201301144607N2
Registration date: 2013-02-10, 1391/11/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-02-10, 1391/11/22
Registrant information
Name
Mohammad Dehghani Firoozabadi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 0447
Email address
mdehghani@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cognitive behavioral stress management effects on depression, anxiety and pain control in patients with migraine headaches.
Public title
Psychotherapy effect on anxiety and depression in migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with migraine headache and patients with significant anxiety and depression test score. Exclusion criterion: lack of regular attendance in classes.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Ghaffari Street.Birjand University of Medical Sciences
City
Birjand
Postal code
Approval date
2012-12-31, 1391/10/11
Ethics committee reference number
19

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
common migraine

Primary outcomes

1

Description
Anxiety
Timepoint
preintervention, postintervention
Method of measurement
Beck test

2

Description
Depression
Timepoint
preintervention, postintervention
Method of measurement
Beck test

3

Description
Migraine headache
Timepoint
preintervention, postintervention
Method of measurement
Frequency of headaches

Secondary outcomes

empty

Intervention groups

1

Description
Eight sessions 1/5 hour cognitive behavioral stress management class
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand University of Medical Sciences clinic
Full name of responsible person
Dr.Dehghani Mohammad
Street address
Taleghani Street. Birjand
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences
Full name of responsible person
Dr. Zarban Asghar
Street address
Ghaffari Street
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dehghani Firoozabadi Mohammad
Position
Assistant professor, Neurologist
Other areas of specialty/work
Street address
Ghaffari Street
City
Birjand
Postal code
Phone
+98 56 1444 7746
Fax
+98 56 1444 7746
Email
mdehghani@bums.ac.ir; mdehghani44@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dehghani Firoozabadi Mohammad
Position
Assistant proffessor, Neurologist
Other areas of specialty/work
Street address
Ghaffari Street
City
Birjand
Postal code
Phone
+98 56 1444 7746
Fax
+98 56 1444 7746
Email
mdehghani@bums.ac.ir; mdehghani44@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dehghani Firoozabadi Mohammad
Position
Assistant proffessor, Neurologist
Other areas of specialty/work
Street address
Ghaffari Street
City
Birjand
Postal code
Phone
+98 56 1444 7746
Fax
+98 56 1444 7746
Email
mdehghani@bums.ac.ir; mdehghani44@yahoo.com
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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