Coping Skills for Migraine: A 6-Month Program

NCT07163559 | Enrolling By Invitation

• 1 other identifier: HU-ERG-EB-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

Migraine; Coping skills; Quality of life; Pain; Disability; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 .

  six months

Secondary Outcomes (3)

• Nottingham Health Profile (NHP)

  six months

• Migraine Disability Assessment Scale (MIDAS)

  six months

• Coping Orientation to Problems Experienced Inventory (Brief-COPE)

  six months

Study Arms (2)

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).

Behavioral: coping skills training

control group

NO INTERVENTION

Interventions

coping skills training BEHAVIORAL

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).

intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of migraine based on the International Classification of Headache Disorders (ICHD-3 beta) criteria,
• age between 18 and 65 years,
• literacy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc Occupational Therapist

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)