Effectiveness of Client-Centered Coping Skills Training in Migraine: A 6-Month Follow-Up, Double-Blind, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Hacettepe University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Visual Analog Scale (VAS)
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •a diagnosis of migraine based on the International Classification of Headache Disorders (ICHD-3 beta) criteria,
- •age between 18 and 65 years,
Exclusion Criteria
- •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.
Arms & Interventions
intervention group
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: coping skills training (Behavioral)
control group
Outcomes
Primary Outcomes
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 .
Secondary Outcomes
- Nottingham Health Profile (NHP)(six months)
- Migraine Disability Assessment Scale (MIDAS)(six months)
- Coping Orientation to Problems Experienced Inventory (Brief-COPE)(six months)
Investigators
Etkin Bagi
Msc Occupational Therapist
Hacettepe University