Comparison of the effectiveness of compassion focuse therapy with transdiagnostic treatment on symptoms of migraine , perceived stress ,dark personality and mental toughness in patients with migraine
Effectiveness and comparison of Compassion Focused Therapy and Transdiagnostic Treatment on migraine symptoms, perceived stress, dark personality and mental strength of patients with migraine
Design
At first, 45 migraine patients who were diagnosed with migraine by a neurologist were selected. They were randomly assigned to two experimental and one control groups.
Settings and conduct
This study was conducted at Shahin Shahr Oil Industry Clinic from October to December 2017. During this study, two experimental groups received psychological training and drug therapy, and the control group received only medication. Before the intervention, the pre-test was performed in three groups and after intervention, three groups of post-test were performed and after two months follow up.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of migraine by the neurologist, having at least 3rd grade education, satisfaction with the company's research, and the absence of any acute and psychological illness other than migraine, which leads to the use of medication. Non-inclusion criteria: receiving psychological treatment in the last 6 months.
Intervention groups
Intervention group 1: Compassion Focused Therapy with drug therapy
Intervention group 2: Transdiagnostic Treatment with drug therapy
Control group: only drug therapy
Comparison of the effectiveness of compassion focuse therapy with transdiagnostic treatment on symptoms of migraine , perceived stress ,dark personality and mental toughness in patients with migraine
Public title
Comparison of the effectiveness of compassion focuse therapy with transdiagnostic treatment on symptoms of migraine
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of migraines by a neurologist
having at least 3rd grade education
Wiling to participate in the research
not having any acute and psychological illness other than migraine
Exclusion criteria:
Psychological treatment in the last 6 months
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Accidental assignment to intervention and control groups which was done through simple randomization.
Random numbers table was used to create random sequences. In order to hide the random allocation, non-transparent sealed envelopes were used.
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
Ethics Committee on Research, Shahrekord Branch, Islamic Azad University
Street address
Shahrekord Branch, Islamic Azad University, Rahmateyeh Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.IAU.SHK.REC.1397.002
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
Ahvaz migraine headache questionnaire score
Timepoint
At the beginning of the study, after the end of the intervention and 2 months after the end of the intervention
Method of measurement
Ahvaz migraine headache questionnaire
2
Description
Chohen Perceived stress scale score
Timepoint
At the beginning of the study, after the end of the intervention and 2 months after the end of the intervention
Method of measurement
Chohen Perceived stress scale
3
Description
Dark Personality Inventory score
Timepoint
At the beginning of the study, after the end of the intervention and 2 months after the end of the intervention
Method of measurement
Johnson & Webster Darkness Personality Questionnaire
4
Description
Mental Toughness Questionnaire score
Timepoint
At the beginning of the study, after the end of the intervention and 2 months after the end of the intervention
Method of measurement
Mental Toughness Questionnaire of Clough & et al
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Compassion focused therapy Protocol (Gilbert, 2014) was performed through 8 90-minute Session, one session a week. Intervention was performed in a group.
Category
Behavior
2
Description
Intervention group 2: The Unified Protocol for Transdiagnostic Treatment (Barlow, 2011) was performed through 8 90-minute Session, one session a week. Intervention was performed in a group.
Category
Behavior
3
Description
Control group: Only taking medication was prescribed by a neurologist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahin Shahr Oil Industry Clinic
Full name of responsible person
Dr. Ahmad Khatibi
Street address
Oil Industry Clinic, Imam Khomeini Street
City
Shahin Shahr
Province
Isfehan
Postal code
٨٣١٦٦٧٣٣١١
Phone
+98 31 4522 9841
Email
m_eshharian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rashid Riahy
Street address
Shahrekord Branch, Islamic Azad University, Rahmateyeh Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1087
Email
riahi.r@iaushk.ac.ir
Web page address
http://research.iaushk.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
Private
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
Mehdi Ashharian
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahrekord Branch, Islamic Azad University, Rahmateyeh Blvd
City
شهرکرد
Province
Isfehan
Postal code
8813733395
Phone
+98 38 3336 1000
Email
m_eshharian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Ashharian
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahrekord Branch, Islamic Azad University, Rahmateyeh Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1087
Email
m_eshharian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Ashharian
Position
Ph.D Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahrekord Branch, Islamic Azad University, Rahmateyeh Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1087
Email
m_eshharian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document