MigraineNCT07163559
Coping Skills for Migraine: A 6-Month Program
A study testing coping skills training in people with Migraine, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effects of client-centered coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine over a 6-month follow-up period. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- a diagnosis of migraine based on the International Classification of Headache Disorders (ICHD-3 beta) criteria,
- age between 18 and 65 years,
- literacy
Who cannot join
- psychiatric disorders,
- traumatic brain injury,
- other types of headaches,
- use of antidepressants, analgesics, anti-inflammatory drugs, or abusive substances (1 week before and during the treatments),
- any additional treatment for migraine during the study period,
- breastfeeding,
- pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Client-Centered Coping Skills Training in Migraine: A 6-Month Follow-Up, Double-Blind, Randomized Controlled Trial
This study aimed to investigate the effects of client-centered coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine over a 6-month follow-up period.
Read the detailed description
Migraine is a significant public health issue characterized by frequently unilateral, recurrent, throbbing headaches. International Headache Disorders define migraine as a headache lasting 4-72 hours, accompanied by nausea, vomiting, phonophobia, or photophobia. Recurrent attacks can make it difficult to perform routine daily activities and movements. The World Health Organization lists migraine as one of the most disabling diseases. Approaches to treating migraine include pharmacological and non-pharmacological interventions. Non-pharmacological approaches aim to increase an individual's coping skills using exercise, stress management, and cognitive-behavioral therapy, which involve physical, mental, and cognitive interventions. While these approaches are practical individually, due to the impact of migraine on an individual's entire life, combined and client-centered approaches are needed.
Coping skills training (CST) has been shown to improve the physical and mental health and well-being of individuals with chronic headaches, significantly reducing pain intensity, migraine attacks, and medication use. It also aims to help individuals adapt to life more productively. Despite its positive effects, limited studies examine the impact of CST on individuals' coping skills and quality of life. A person-centered approach that combines various intervention components can enhance personal control and effectiveness in managing headaches. Due to the unpredictable timing of severe migraine attacks and the variable frequency of symptoms, client-centered coping skills training is recommended for managing migraines. Therefore, this study aimed to investigate the effects of client-centered coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine over a 6-month follow-up period.
- Conditions
- Migraine
- Being tested
- coping skills training
- Keywords
- Migraine, Coping skills, Quality of life, Pain, Disability, Randomized controlled trial
- 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 trainingBehavioural
CST aims to improve physical/mental health in chronic headache patients by reducing pain intensity, migraine attacks, and medication use. The program includes 8 sessions (2/week) covering:
Client-centered problem-solving \& migraine education (COPM-based), Activity pacing, stress management, and healthy habits, Energy conservation techniques, Social participation, Program evaluation. Session durations: Session 1 (45 min), Sessions 2-6 (60-75 min), Sessions 7-8 (60 min).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | CST aims to improve physical/mental health in chronic headache patients by reducing pain intensity, migraine attacks, and medication use. The program includes 8 sessions (2/week) covering:
Client-centered problem-solving \& migraine education (COPM-based), Activity pacing, stress management, and healthy habits, Energy conservation techniques, Social participation, Program evaluation. Session durations: Session 1 (45 min), Sessions 2-6 (60-75 min), Sessions 7-8 (60 min). Receives: Behavioral: coping skills training |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) is a pain intensity measurement scale. It consists of a horizontal line 10 cm in length. The participants were asked to indicate their average pain over the last month by drawing a line, placing a dot, or marking a point on this line. The value of 10 on the line's right side represents severe pain, while the value of 0 on the left side represents the absence of pain. This indicates that the maximum degree of pain is at the far right boundary, and the minimum is at the far left boundary. The length of the distance between the point the participants mark on the line and the point representing the absence of pain indicates the intensity of their pain. The internal consistency of the VAS scale has been found to be 0.82 .
Measured: six months
Secondary outcomes (3)
Nottingham Health Profile (NHP)
Nottingham Health Profile (NHP) is a quality of life scale used to measure individuals' perceived health problems and how they affect their daily activities. It was developed by a group of researchers in the Department of Community Health at the University of Nottingham, England, in 1975 and completed in 1981. The NHP includes 38 items under six main headings of health: pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), physical mobility (8 items), and energy level (3 items). Individuals respond with either a yes or no to the item that is appropriate for them. Scores for each parameter range from 0 to 100, with a maximum total score of 600. The higher the score for any parameter, the more severe the perceived problem. This study used the Turkish version of the NHP, which has demonstrated excellent internal consistency with a Cronbach's alpha of 0.82.
Measured: six months
Migraine Disability Assessment Scale (MIDAS)
The Migraine Disability Assessment Scale (MIDAS) is used to evaluate disability caused by migraine. It is a valid and reliable scale developed by Stewart et al. to investigate the impact of migraine over the past three months. MIDAS's 1st, 3rd, and fifth questions provide the number of days missed due to migraine-related absence from school/work, household, and leisure activities. The 2nd and 4th questions provide the number of days with a 50% reduction in work/school performance due to migraine. This study used the Turkish version of MIDAS, which demonstrated good test-retest reliability with a value of 0.77.
Measured: six months
Coping Orientation to Problems Experienced Inventory (Brief-COPE)
Coping Orientation to Problems Experienced Inventory (Brief-COPE) assesses individuals' coping styles. It consists of 14 subscales, each containing two items, for a total of 28 items, to evaluate active coping, planning, using instrumental support, using emotional support, venting, self-distraction, behavioral disengagement, self-blame, positive reframing, humor, substance use, denial, acceptance, and religion coping. Each subscale is evaluated separately. The scale items include 4-point Likert-type response options, with responses ranging from "4. Mostly true" to "1. Not at all true." Low scores indicate less use of the coping style, while high scores indicate greater use. This study used the Turkish version of the Brief COPE, which demonstrates a high internal consistency with a Cronbach alpha value of 0.85.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Etkin Bagi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163559
- Sponsor's protocol ID
- HU-ERG-EB-03
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Client-Centered Coping Skills Training in Migraine: A 6-Month Follow-Up, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07163559
- Acronym / sponsor ID
- HU-ERG-EB-03
- Conditions
- Migraine
- Keywords
- Migraine, Coping skills, Quality of life, Pain, Disability, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to investigate the effects of client-centered coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine over a 6-month follow-up period.
Detailed description
Migraine is a significant public health issue characterized by frequently unilateral, recurrent, throbbing headaches. International Headache Disorders define migraine as a headache lasting 4-72 hours, accompanied by nausea, vomiting, phonophobia, or photophobia. Recurrent attacks can make it difficult to perform routine daily activities and movements. The World Health Organization lists migraine as one of the most disabling diseases. Approaches to treating migraine include pharmacological and non-pharmacological interventions. Non-pharmacological approaches aim to increase an individual's coping skills using exercise, stress management, and cognitive-behavioral therapy, which involve physical, mental, and cognitive interventions. While these approaches are practical individually, due to the impact of migraine on an individual's entire life, combined and client-centered approaches are needed.
Coping skills training (CST) has been shown to improve the physical and mental health and well-being of individuals with chronic headaches, significantly reducing pain intensity, migraine attacks, and medication use. It also aims to help individuals adapt to life more productively. Despite its positive effects, limited studies examine the impact of CST on individuals' coping skills and quality of life. A person-centered approach that combines various intervention components can enhance personal control and effectiveness in managing headaches. Due to the unpredictable timing of severe migraine attacks and the variable frequency of symptoms, client-centered coping skills training is recommended for managing migraines. Therefore, this study aimed to investigate the effects of client-centered coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine over a 6-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: coping skills trainingCST aims to improve physical/mental health in chronic headache patients by reducing pain intensity, migraine attacks, and medication use. The program includes 8 sessions (2/week) covering: Client-centered problem-solving \& migraine education (COPM-based), Activity pacing, stress management, and healthy habits, Energy conservation techniques, Social participation, Program evaluation. Session durations: Session 1 (45 min), Sessions 2-6 (60-75 min), Sessions 7-8 (60 min). |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a diagnosis of migraine based on the International Classification of Headache Disorders (ICHD-3 beta) criteria,
- age between 18 and 65 years,
- literacy
Key exclusion criteria (7 listed)
- psychiatric disorders,
- traumatic brain injury,
- other types of headaches,
- use of antidepressants, analgesics, anti-inflammatory drugs, or abusive substances (1 week before and during the treatments),
- any additional treatment for migraine during the study period,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coping skills trainingCST aims to improve physical/mental health in chronic headache patients by reducing pain intensity, migraine attacks, and medication use. The program includes 8 sessions (2/week) covering: Client-centered problem-solving \& migraine education (COPM-based), Activity pacing, stress management, and healthy habits, Energy conservation techniques, Social participation, Program evaluation. Session durations: Session 1 (45 min), Sessions 2-6 (60-75 min), Sessions 7-8 (60 min). | Behavioural | intervention group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: six months
Visual Analog Scale (VAS) is a pain intensity measurement scale. It consists of a horizontal line 10 cm in length. The participants were asked to indicate their average pain over the last month by drawing a line, placing a dot, or marking a point on this line. The value of 10 on the line's right side represents severe pain, while the value of 0 on the left side represents the absence of pain. This indicates that the maximum degree of pain is at the far right boundary, and the minimum is at the far left boundary. The length of the distance between the point the participants mark on the line and the point representing the absence of pain indicates the intensity of their pain. The internal consistency of the VAS scale has been found to be 0.82 .
3 secondary outcomes
Nottingham Health Profile (NHP)
Time frame: six months
Migraine Disability Assessment Scale (MIDAS)
Time frame: six months
Coping Orientation to Problems Experienced Inventory (Brief-COPE)
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coping skills training in people with Migraine, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025.