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MigraineNCT05809375

Coping Skills Training in Individuals With Migraine

A study testing Coping Skills Training in people with Migraine, run by Hacettepe University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine
What is being tested?
Coping Skills Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
May 2023to Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Etkin BAĞCI contact

+905067983965

etkinbag@gmail.com

Hacettepe University contact

About this study

Official title: Investigation of the Effects of a Client-centered Coping Skills Training in Individuals With Migraine: A Randomized Controlled Study

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.

Conditions
Migraine
Being tested
Coping Skills Training
Keywords
Migraine, Pain, Coping Skills, Quality of Life
Medical subject headings
Migraine Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coping Skills TrainingOther

    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.

Study groups in NCT05809375
Study groupRoleWhat they receive
Coping Skills Training GroupActive comparatorCoping 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.
Receives: Other: Coping Skills Training
Control GrupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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."

    Measured: four weeks

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2023
  2. Study startMay 2023 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study was designed as an assessor-blind, randomized controlled, and parallel-group study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05809375
Sponsor's protocol ID
HU-ERG-EB-01
Status last verified
Apr 2023
First submitted
22 Mar 2023
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Coping Skills Training in people with Migraine, run by Hacettepe University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Etkin BAĞCI (+905067983965, etkinbag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: four weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05809375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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