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The Comparison of the Effectiveness of Combined Medication (Pharmacotherapy and Brief Mindfulness-Based Therapy) and Pharmacotherapy in Improving Migraine Symptoms and Sleep Quality in Women with Migraine

Protocol summary

Study aim
The Comparison of the effectiveness of Combined medication (Pharmacotherapy and brief mindfulness-based therapy) and pharmacotherapy in improving Migraine symptoms and sleep quality in women with migraine
Design
A randomized, single blind clinical trial with a waiting group design of 28 patients, enrolled between July 2018 and October 2018
Settings and conduct
28 people were selected through available sampling method randomly and without being notified, were divided into two groups: Experiment and Waiting. For the experimental group, in addition to the conventional drug therapy, brief mindfulness-based therapy was held that lasted 2 sessions a week, for 2 weeks. But for the waiting group, only the conventional drug therapy was performed. At the end of the research, psychological intervention was also performed for the waiting group for ethical considerations
Participants/Inclusion and exclusion criteria
Inclusion criteria included receiving a diagnosis of migraine according to the psychiatrist's opinion, the age of 18-60, Level of education at least middle school and female gender. Exclusion criteria included any severe psychological disorders such as psychosis, bipolar disorder, severe depression, or personality disorders, a history of drug abuse and dependency on any particular substance, receiving any psychological treatments for migraine over the past two years and changing in drug use during the study
Intervention groups
For the waiting group, only the conventional drug therapy was performed and In the experimental group, in addition to conventional drug therapy, brief mindfulness-based therapy was performed
Main outcome variables
Migraine symptoms Sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190311043018N1
Registration date: 2019-05-04, 1398/02/14
Registration timing: retrospective

Last update: 2019-05-04, 1398/02/14
Update count: 0
Registration date
2019-05-04, 1398/02/14
Registrant information
Name
Hossein Hosseinpour
Name of organization / entity
The university of urmia
Country
Iran (Islamic Republic of)
Phone
+98 31 3433 4140
Email address
h.hosseinpoor72@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
2018-07-21, 1397/04/30
Actual recruitment end date
2018-10-22, 1397/07/30
Trial completion date
2018-11-21, 1397/08/30
Scientific title
The Comparison of the Effectiveness of Combined Medication (Pharmacotherapy and Brief Mindfulness-Based Therapy) and Pharmacotherapy in Improving Migraine Symptoms and Sleep Quality in Women with Migraine
Public title
the Effectiveness of Combined Medication (Pharmacotherapy and Mindfulness) in Improving Migraine and Sleep Quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Getting Diagnosis of Migraine Based on Psychiatrist's Comment Level of education is at least middle school Not receiving any kind of psychological treatment for migraine over the past two years
Exclusion criteria:
Having any severe psychiatric disorder such as psychosis, bipolar disorder, severe depression or personality disorders History of drug abuse and dependence on any other specific substance Changing in drug dosage
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Actual sample size reached: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling Random unit: person Randomization Tool: Random Number Tables
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in the study did not know the allocation of study groups to the experimental and waiting group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences and Health Services, Hezar-Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-02-20, 1396/12/01
Ethics committee reference number
IR.MUI.MED.REC.1396.358

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.0 G43.
ICD-10 code description
Migraine without aura

Primary outcomes

1

Description
Score of participants in Migraine Disability Assessment questionnaire
Timepoint
Migraine Disability Assessment before the intervention and after the intervention
Method of measurement
Migraine Disability Assessment questionnaire

2

Description
Score of participants in Pittsburgh Sleep Quality Index
Timepoint
Sleep Quality Assessment before the intervention and after the intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The MBT intervention, based on Mindfulness-based stress reduction and Mindfulness Based Cognitive Therapy was conducted over a 3-week period involving twice-weekly group classes and daily practice. The program, which included a particular focus on management of headache pain and related psycho-social sequels, and management of stress as a contributing factor to headache, was developed by some of the authors who are psychologists with formal training in mindfulness therapy and extensive teaching, practice and research experience in mindfulness-based meditation. This protocol was first used in a research entitled "Brief Mindfulness-Based Therapy for Chronic Tension-Type Headache". In addition, individuals in the intervention group, along with psychological treatment, followed their drug treatment under the supervision of their psychiatrist.
Category
Treatment - Other

2

Description
Control group: For control group in this study, no psychological treatment was applied and During the study, they only followed their own drug treatment under the supervision of a psychiatrist
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychosomatic Research Center
Full name of responsible person
Dr. Hamid Afshar
Street address
Psychosomatic Research Center, Second Floor, Shahid Mottahari Clinic, Shariati West Street, Hakim Nezami Street
City
Isfahan
Province
Isfehan
Postal code
8173948763
Phone
+98 31 3628 9966
Email
psrc@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Hamid Afshar
Street address
Psychosomatic Research Center, Second Floor, Shahid Mottahari Clinic, Shariati West Street, Hakim Nezami Street
City
Isfahan
Province
Isfehan
Postal code
8173948763
Phone
+98 31 3628 9966
Email
psrc@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
The university of Kharazmi
Full name of responsible person
Hossein Hosseinpour
Position
M.A in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Floor 4, Pardis Bldg, 17th Alley, 5Azar Ave, Jaberansari Ave
City
Esfahan
Province
Isfehan
Postal code
8138958374
Phone
+98 31 3433 3800
Fax
Email
h.hosseinpoor72@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The university of Kharazmi
Full name of responsible person
Hossein Hosseinpour
Position
M.A in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Floor 4, Pardis Bldg, 17th Alley, 5Azar Ave, Jaberansari Ave
City
Esfahan
Province
Isfehan
Postal code
8138958374
Phone
+98 31 3433 3800
Fax
Email
h.hosseinpoor72@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The university of Kharazmi
Full name of responsible person
Hossein Hosseinpour
Position
M.A in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Floor 4, Pardis Bldg, 17th Alley, 5Azar Ave, Jaberansari Ave
City
Esfahan
Province
Isfehan
Postal code
8138958374
Phone
+98 31 3433 3800
Fax
Email
h.hosseinpoor72@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
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