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Status unknownNCT05809375Updated Apr 12, 2023

Coping Skills Training in Individuals With Migraine

An interventional study of Coping Skills Training in Migraine, sponsored by Hacettepe University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Migraine

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Keywords

  • Migraine
  • Pain
  • Coping Skills
  • Quality of Life
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's planned enrollment of 70 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Coping Skills Training Group

    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.

    Other: Coping Skills Training

  • No intervention
    Control Grup

    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.

Interventions

  • OtherCoping Skills Training

    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.

06

What researchers measure

Primary outcomes

  1. 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."

    Time frame: four weeks

Secondary outcomes

  1. 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.

    Time frame: four weeks

  2. 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.

    Time frame: four weeks

  3. 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.

    Time frame: four weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05809375
Lead sponsor
Hacettepe University
Responsible party
Etkin Bagi (Msc Occupational Therapist, Hacettepe University) — Principal investigator
First posted
Apr 12, 2023
Start date
May 2023 (estimated)
Primary completion
Jun 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
Apr 12, 2023

Study contacts

Etkin BAĞCI
Contact
etkinbag@gmail.com
+905067983965
Hacettepe University
Contact
Gamze Ekici
principal investigator · Hacettepe University
Mahmut Yaran
study chair · Ondokuz Mayıs University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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