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Coping Skills Training in Individuals With Migraine

Primary Purpose

Migraine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coping Skills Training
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Pain, Coping Skills, Quality of Life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: have a diagnosis of migraine meeting the International Headache Society diagnostic criteria (ICHD-3 beta International Classification of Headache Disorders), to be between the ages of 18-65, to have a migraine onset age younger than 50 (migraine onset age shouldn't be 50 years or more because being above is usually a secondary reason) to be literate. Exclusion Criteria: have psychotic disorders, organic brain damage, other types of headaches, a history of traumatic head injuries, neck pain, any pathology causing headaches in the head and neck, alcohol or substance use, pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Coping Skills Training Group

    Control Grup

    Arm Description

    Coping skills training (CST) will be given to the intervention group in line with the goals of the International Headache Society. Of the participants included in this study, the ones in the intervention group will be evaluated before and after the intervention.

    The participants in the control group will be evaluated at the beginning and after four weeks. CST will be given to the control group participants, if they want to, after the final evaluation.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale (VAS)
    The patients are asked to rate the average pain perception they felt during the day in a 10 cm straight line. The beginning of the line means "0 = no pain," and the end of the line means "10 = maximal pain."

    Secondary Outcome Measures

    Nottingham Health Profile (NHP)
    The Quality of life of the participants is assessed by using the NHP. It consists of 38 items assessing how severe an impact the respondent thinks their health is having on six dimensions: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. Every item has a different weight, depending on the severity of the symptom. The sum of the weighted scores is 100 for each subdimension. Thus, summing all weighted values of every item, the score between 0 and 100 is obtained for each subdimension. The total score was obtained by summing the scores of six subdimensions, giving values between 0 and 600. Higher scores indicate a greater level of distress. The NHP is valid and reliable in Turkish populations.
    Migraine Disability Assessment Score (MIDAS)
    It consists of five questions that measures the influence of headaches on three domains of activity over the preceding 3 months: paid and school work, household work, and leisure activities with family or in social situations. MIDAS measures the number of days in which migraine interferes with these activities, and establishes four disability grades: minimal, mild, moderate, and severe disability. The MIDAS is valid and reliable in Turkish populations.
    The brief COPE
    The Brief COPE measures strategies for coping with stress and includes 14 subscales in which two items are grouped into two coping strategies: effective approach coping (active coping, acceptance, positive reframing, planning, use of emotional or instrumental support) and ineffective avoidant coping (denial, self-distraction, substance use, behavioural disengagement, venting, and self-blame). Each question has a selection range from 1 ("I have not been doing this at all") to 4 ("I have been doing this a lot"), and the higher subscale scores indicate using those coping strategies more. The Brief COPE is valid and reliable in Turkish populations.

    Full Information

    First Posted
    March 22, 2023
    Last Updated
    April 9, 2023
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05809375
    Brief Title
    Coping Skills Training in Individuals With Migraine
    Official Title
    Investigation of the Effects of a Client-centered Coping Skills Training in Individuals With Migraine: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was planned to investigate the effects of coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine.
    Detailed Description
    Migraine is a type of headache that lasts 4-72 hours, and it is characterized by throbbing pain on one side of the head, and recurrent attacks, making routine daily activities and movements difficult. Also, nausea and vomiting may accompany migraine, and sensitivity to both light and sound may increase. The World Health Organization (WHO) lists migraine as the disease that causes the most disability. Approaches to the treatment of migraine consist of pharmacological and non-pharmacological treatments. Within the scope of non-pharmacological approaches, it is aimed to increase the coping skills of the individual by using methods such as exercise, stress management, and cognitive behavioral therapy, which include physical, mental, and cognitive interventions. Although these approaches are effective respectively, since migraine affects the whole life of the individual, there is a need for applications in which the approaches are applied with a combined and individual perspective. It has been shown that coping skills training improves both the physical and mental health and well-being of individuals with chronic headaches. It is known to cause a decrease in pain intensity, migraine attacks, and drug use. At the same time, it is aimed to adapt the individual to live efficiently. Despite these positive effects, there is a limited number of studies examining the effect of migraine coping skills training on individuals' disabilities and coping skills. Therefore, within the scope of this study, the effects of client-centered coping skills training on pain, disability, coping skills, and quality of life were examined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine
    Keywords
    Migraine, Pain, Coping Skills, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study was designed as an assessor-blind, randomized controlled, and parallel-group study.
    Masking
    Outcomes Assessor
    Masking Description
    Outcome assessments will be performed by an investigator who was blinded to group allocation. Coping Skills Training was given to the control group participants, if they wanted to, after the final evaluation.
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Coping Skills Training Group
    Arm Type
    Active Comparator
    Arm Description
    Coping skills training (CST) will be given to the intervention group in line with the goals of the International Headache Society. Of the participants included in this study, the ones in the intervention group will be evaluated before and after the intervention.
    Arm Title
    Control Grup
    Arm Type
    No Intervention
    Arm Description
    The participants in the control group will be evaluated at the beginning and after four weeks. CST will be given to the control group participants, if they want to, after the final evaluation.
    Intervention Type
    Other
    Intervention Name(s)
    Coping Skills Training
    Intervention Description
    In the intervention, it was acted in a way to include the educational content determined by the International Headache Association and with a problem-solving perspective. The coping skills training contents in the literature were combined, and the CST prepared by including the most used and related contents will be given. CST includes a targeted therapy specifically developed for this study to address the needs and expectations of individuals with migraine. The targeted CST was designed by the authors, consisting of an occupational therapist, and two physiotherapists with clinical, and academic experience. It is planned as a total of eight sessions, and two sessions per week. CST includes giving information about migraine, activity tempo, progressive muscle relaxation exercise, stress management, social participation, leisure time management, general evaluation of the program, and home program.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale (VAS)
    Description
    The patients are asked to rate the average pain perception they felt during the day in a 10 cm straight line. The beginning of the line means "0 = no pain," and the end of the line means "10 = maximal pain."
    Time Frame
    four weeks
    Secondary Outcome Measure Information:
    Title
    Nottingham Health Profile (NHP)
    Description
    The Quality of life of the participants is assessed by using the NHP. It consists of 38 items assessing how severe an impact the respondent thinks their health is having on six dimensions: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. Every item has a different weight, depending on the severity of the symptom. The sum of the weighted scores is 100 for each subdimension. Thus, summing all weighted values of every item, the score between 0 and 100 is obtained for each subdimension. The total score was obtained by summing the scores of six subdimensions, giving values between 0 and 600. Higher scores indicate a greater level of distress. The NHP is valid and reliable in Turkish populations.
    Time Frame
    four weeks
    Title
    Migraine Disability Assessment Score (MIDAS)
    Description
    It consists of five questions that measures the influence of headaches on three domains of activity over the preceding 3 months: paid and school work, household work, and leisure activities with family or in social situations. MIDAS measures the number of days in which migraine interferes with these activities, and establishes four disability grades: minimal, mild, moderate, and severe disability. The MIDAS is valid and reliable in Turkish populations.
    Time Frame
    four weeks
    Title
    The brief COPE
    Description
    The Brief COPE measures strategies for coping with stress and includes 14 subscales in which two items are grouped into two coping strategies: effective approach coping (active coping, acceptance, positive reframing, planning, use of emotional or instrumental support) and ineffective avoidant coping (denial, self-distraction, substance use, behavioural disengagement, venting, and self-blame). Each question has a selection range from 1 ("I have not been doing this at all") to 4 ("I have been doing this a lot"), and the higher subscale scores indicate using those coping strategies more. The Brief COPE is valid and reliable in Turkish populations.
    Time Frame
    four weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: have a diagnosis of migraine meeting the International Headache Society diagnostic criteria (ICHD-3 beta International Classification of Headache Disorders), to be between the ages of 18-65, to have a migraine onset age younger than 50 (migraine onset age shouldn't be 50 years or more because being above is usually a secondary reason) to be literate. Exclusion Criteria: have psychotic disorders, organic brain damage, other types of headaches, a history of traumatic head injuries, neck pain, any pathology causing headaches in the head and neck, alcohol or substance use, pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Etkin BAĞCI
    Phone
    +905067983965
    Email
    etkinbag@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hacettepe University
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gamze Ekici
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mahmut Yaran
    Organizational Affiliation
    Ondokuz Mayıs University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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