Effectiveness of cognitive-behavioral stress management (CBSM) on reducing headaches, endurance distress, emotional collapse and cognitive avoidance in patients with tension headaches And compare it to drug therapy
The effect of cognitive behavioral stress management method on reduction of headache, cognitive avoidance and alexithymia in patients with tension headaches and comparison of this method with Pharmacotherapy.
Design
In this study, clinical trial، Forty people with tension headaches in Sari Will be divided. into four groups Selected by random sampling method and randomly. Three experimental groups and one control group
Settings and conduct
Groups that should be present in the management class, in 8 sessions, in the mental Health and Psychiatry Clinic of Sari, will be treated by the researcher under stress management training and are familiar with research goals before attending the class. (Not all research goals). The two and four groups that do not need to know the goals of the project are only given general information.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Complaint of headache for at least three months, having tension headaches according to the International Association of Headache, the ability to read and write,
Exclusion criteria: Having a known malignant disease or cognitive impairment caused by psychosis.
Intervention groups
Samples Will be divided into 4 groups.
3 experimental groups and one control group.
The first group of experiments receive only cognitive-behavioral management therapy for stress
The second group of experiments was purely pharmacotherapeutic and The third group received the third test for both cognitive-behavioral management and drug therapy and No control group received any treatment.
Main outcome variables
Independent variables include drug therapy, stress management cognitive-behavioral therapy.
Dependent variables include tension headaches, cognitive avoidance, and emotional distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200413047057N1
Registration date:2020-05-18, 1399/02/29
Registration timing:registered_while_recruiting
Last update:2020-05-18, 1399/02/29
Update count:0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Seyed abdollah Amiri argmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 1386
Email address
seyedamiri93@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-08, 1399/02/19
Expected recruitment end date
2020-07-09, 1399/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of cognitive-behavioral stress management (CBSM) on reducing headaches, endurance distress, emotional collapse and cognitive avoidance in patients with tension headaches And compare it to drug therapy
Public title
Comparison of the effectiveness of two methods of drug therapy and cognitive-behavioral stress management (CBSM) To reduce tension headaches, cognitive avoidance and emotional distress of patients with tension headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A history of at least three months complaining of headaches
Having complete specifications of tension headaches according to the criteria of the International Headache Association
Satisfaction with attending all training sessions
Has a minimum literacy degree
Having enough time to attend meetings
Exclusion criteria:
The presence of a known malignancy or disease
Cognitive disorders caused by psychosis such as schizophrenia, deep depression, alcoholism, drugs or other psychotropic substances
Age
From 17 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Sari Branch
Street address
Unit 9، Mahsai building 4، Alley of Victory 12، Piroozi street
City
sari
Province
Mazandaran
Postal code
4818774341
Approval date
2019-11-09, 1398/08/18
Ethics committee reference number
IR.IAU.SARI.REC.1398.127
Health conditions studied
1
Description of health condition studied
Tension headache
ICD-10 code
G44.2
ICD-10 code description
Tension-type headache
Primary outcomes
1
Description
Tension headache score in the questionnaire designed based on the diagnostic standards of the International Headache Association
Timepoint
At the beginning of the study and at the end of the study (after the treatment process, which takes about two months).
Method of measurement
Designed form of tension headache based on the diagnostic standards of the International Headache Association.
Secondary outcomes
1
Description
The Sexton and Dadgas Cognitive Avoidance Questionnaire scores 25 questions.
Timepoint
Before treatment and after treatment, the interval between them is two months
Method of measurement
Using a questionnaire of 25 cognitive avoidance questions of Sexton and Dagas
2
Description
Simmons and Gauger's Anxiety Tolerance Score
Timepoint
Before treatment and after treatment, the interval between them is two months
Method of measurement
Using Simmons and Gauger's Anxiety Tolerance Questionnaire, which is 15 questions.
3
Description
Toronto's Emotional Questionnaire Score
Timepoint
Before treatment and after treatment, the interval between them is two months
Method of measurement
Using Toronto's Emotional Questionnaire, which has 20 questions.
Intervention groups
1
Description
First Intervention Group:The group will merely receive stress management training in cognitive-behavioral manner. This treatment is in the form of a stress management class in 8 sessions of one hour, which is presented to subjects according to Anthony's book.
Category
Treatment - Other
2
Description
Intervention group:
Category
Treatment - Other
3
Description
Intervention group: This group receives medicine and stress management together.
Category
Treatment - Other
4
Description
Control group: This group does not receive any treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Baghbanian Neurology Clinic
Full name of responsible person
Dr. Seyed mohammad Baghbanian
Street address
Sougal Building، Qaani Alley، Farhang Street
City
sari
Province
Mazandaran
Postal code
4818774251
Phone
+98 11 3311 3527
Email
smbaghbanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rahman Ghaffari
Street address
Farahabad Street
City
Sari
Province
Mazandaran
Postal code
4818774197
Phone
+98 11 3444 5111
Email
Rghaffari@ut.ac.ir
Web page address
Http://www.iausari.ac.ir
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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed abdollah Amiri argmand
Position
Psychological counselor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 9، Mahsai 4 Building, Piroozi Alley 12، Piroozi St.,
City
Sari
Province
Mazandaran
Postal code
4818774341
Phone
+98 11 3311 1386
Fax
Email
seyedamiri93@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed abdollah Amiri argmand
Position
Psychological counselor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 9، Mahsai 4 Building, Piroozi Alley 12، Piroozi St.,
City
Sari
Province
Mazandaran
Postal code
4818774341
Phone
+98 11 3311 1386
Fax
Email
seyedamiri93@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed abdollah Amiri argmand
Position
Psychological counselor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 9، Mahsai 4 Building, Piroozi Alley 12، Piroozi St.,
City
Sari
Province
Mazandaran
Postal code
4818774341
Phone
+98 11 3311 1386
Fax
Email
seyedamiri93@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available