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The effectiveness of cognitive-behavioral therapy on stress, cognitive flexibility and quality of life in patients with migraine

Protocol summary

Study aim
The effectiveness of cognitive-behavioral therapy on stress, cognitive flexibility and quality of life in migraine patients
Design
In terms of the research method, the current research is a semi-experimental study with a pre-test and post-test design with a control group. Simple randomization was used on 40 patients with migraine.
Settings and conduct
The statistical population of this research includes patients with migraines who refer to medical centers in Rasht city. All participants complete the questionnaires of perceived stress by Cohen et al., the World Health Organization's short quality of life scale, and the cognitive flexibility questionnaire, and only the intervention group is subjected to cognitive-behavioral therapy, and at the end, a post-test will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria; A person's migraine disease must be confirmed by a doctor and a neurologist exit criteria; Not having migraine, Participant suffering from other physical diseases
Intervention groups
After completing the questionnaires, the patients participating in the research are divided into two groups, and then the intervention group is subjected to cognitive-behavioral therapy, and in the intervention group, the consent form to participate in the research is provided to them.The tasks and the way of conducting the sessions are explained, and the questions and doubts of the participants in the research are answered, so the participants are mentally prepared to attend the treatment sessions. The control group does not receive the treatment and Then at the end of the post-test in both groups.
Main outcome variables
Stress, cognitive flexibility, quality of life, cognitive behavioral therapy.

General information

Reason for update
Acronym
CBT
IRCT registration information
IRCT registration number: IRCT20220723055535N1
Registration date: 2022-07-30, 1401/05/08
Registration timing: registered_while_recruiting

Last update: 2022-07-30, 1401/05/08
Update count: 0
Registration date
2022-07-30, 1401/05/08
Registrant information
Name
Sahereh Asan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3188 4999
Email address
asansahereh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-29, 1401/05/07
Expected recruitment end date
2022-08-27, 1401/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral therapy on stress, cognitive flexibility and quality of life in patients with migraine
Public title
The effect of cognitive_behavioral therapy on stress, cognitive flexibility and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A person's migraine must be confirmed by a doctor and a neurologist
Exclusion criteria:
The person does not suffer from migraine Participants suffering from other physical diseases
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple randomization in which 40 patients with migraine are randomly selected in the centers. The randomization tool is a random table of numbers that the researcher moves the numbers down on one of the numbers in the random table and moves to the right and down, and finally records the numbers and divides them into two experimental groups (20 people), assigns the control group (20 people) whose number has already been determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lahijan Islamic Azad University
Street address
Kashif Sharfi Street, Lahijan, Gilan Province.
City
Lahijan
Province
Guilan
Postal code
۳۹۵۱۵-۴۴۱۶۹
Approval date
2022-06-12, 1401/03/22
Ethics committee reference number
IR.IAU.LIAU.REC.1401.019

Health conditions studied

1

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

Primary outcomes

1

Description
Stress variable in the perceived stress scale of Cohen et al
Timepoint
Before and after treatment
Method of measurement
The perceived stress scale of Cohen et al

2

Description
Cognitive flexibility in cognitive flexibility questionnaire
Timepoint
Before and after treatment
Method of measurement
Cognitive flexibility questionnaire of Dennis and Vanderwaal

3

Description
Quality of life in the World Health Organization quality of life questionnaire
Timepoint
Before and after treatment
Method of measurement
World Health Organization Quality of Life Short Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The number of 40 patients will be randomly selected and will be allocated in two intervention groups (20 people) and control group (20 people). At the beginning and at the end of the treatment, both groups complete the questionnaires of perceived stress by Cohen and colleagues and the World Health Organization's short scale of quality of life and cognitive flexibility as a pre-test and post-test, and only the intervention group will undergo cognitive-behavioral therapy. took The informed consent form is provided to the participants, and necessary explanations are provided regarding the purpose and structure of the treatment, how to conduct the treatment sessions, and the questions are answered.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasht city medical centers
Full name of responsible person
Sahereh Asan
Street address
Hasti Building, Koche Nevut 4, Sergol Square, Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
41586-18485
Phone
+98 990 933 0388
Email
asansahereh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Khara
Street address
Kashif Sharfi Street, Lahijan, Gilan Province
City
Lahijan
Province
Guilan
Postal code
۳۹۵۱۵-۴۴۱۶۹
Phone
+98 13 4222 9081
Email
asansahereh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahereh Asan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Hasti Building, Koche Nevut 4, Sergol Square, Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
41586-18485
Phone
+98 13 3188 4999
Email
asansahereh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahereh Asan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Hasti Building, Koche Nevut 4, Sergol Square, Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
41586-18485
Phone
+98 13 3188 4999
Email
asansahereh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahereh Asan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Hasti Building, Koche Nevut 4, Sergol Square, Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
41586-18485
Phone
+98 13 3188 4999
Email
asansahereh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All the data obtained from the questionnaire and test results will be published
When the data will become available and for how long
The access period starts 5 months after the results are published
To whom data/document is available
Data and documentation will be accessible to all researchers in the field of research under study.
Under which criteria data/document could be used
If people want data and documents, send a message to a personal email.
From where data/document is obtainable
Applicants should contact Sahereh Asan with mobile number 09909330388 or personal email asansahereh@gmail.com to request the desired documents or data.
What processes are involved for a request to access data/document
Applicants should call 09909330388 or email asansahereh@gmail.com to receive data or documents, documents will be provided to them within 72 hours or one week.
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