Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine

Migraine Clinical Trial

Official title:

Exploring the Psychosomatic Factors Influencing and Moderating the Efficacy of Holistic Care and Personalized Treatment for Migraine Patients: A Prospective Longitudinal Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334237
• Other study ID #: Y_113_0009
• Status: Recruiting
• Start date: April 18, 2024
• Est. completion date: February 21, 2026

Study information

• Verified date: May 2024
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research project aims at exploring the psychosomatic factors that influence and moderate the efficacy of holistic care and personalized treatment for migraine patients. It is a prospective longitudinal observational study. The project's goal is to understand how physical, psychological, spiritual, and social factors affect the care and treatment outcomes for migraineurs. The study will include participants aged 18 to 65, who meet the International Headache Society's criteria for migraines. It will utilize a range of methodologies including questionnaires, interviews, and medical records to collect data on various factors like lifestyle, psychological state, and social support. The project will assess the effectiveness of treatments, compliance, and other outcomes such as emotional and sleep conditions.

Description:

In this study, participants will be recruited through clinics. All the participants will be asked to keep a migraine diary for the duration of three months. In addition to that, the participants will fill out questionnaires that measures depression, anxiety, well-being and migraine related disability. This study does not intervene with the routine clinical care. The investigators merely observe through participant's diary and other patient reports to find out about how psychological and social factors might lead to different clinical outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 21, 2026
• Est. primary completion date: February 21, 2025
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• individuals aged between 18 and 65 who meet the International Headache Society's criteria for migraines

Exclusion Criteria:

• incapacitate such as dementia or cognitive deficiency

• illiterate, or could not sign informed consents

• severe disorder or co-morbidities that the doctors advice against participation

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• personalized treatment
According to the condition of each individuals, the study continues their routine clinical care. The study does not offer anything more than a routine clinical care. It is named personalized treatment because the condition of each individual varies, so the doctor may prescribe or offer clinical advice accordingly. .

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Chang Hua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine attack frequency	The frequency of migraine attacks will be assessed by the number of days with migraine attacks recorded in the migraine diary.	3 months
Primary	Migraine attack intensity	The intensity of migraine attacks will be assessed by the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.	3 months
Primary	Migraine attack duration	The duration of each migraine attack will be recorded in the migraine diary, measured in hours.	3 months
Primary	Effectiveness of acute medication	The effectiveness of acute medication will be assessed by a 4-point scale measuring the degree of pain relief after medication administration, recorded in the migraine diary: No effect at all; Minimal effect, headache slightly improved; Good effect, headache significantly improved; Very effective, pain completely resolved	3 months
Secondary	Compliance rate of migraine diary	The compliance rate of migraine diary will be calculated as the percentage of days with appropriately completed diary entries out of the total days of participation.	3 months
Secondary	Compliance rate of lifestyle modification	The compliance rate of lifestyle modification will be assessed by self-reported adherence to recommended changes (e.g., sleeping time, or exercising) in the migraine diary.	3 months
Secondary	depression	Depression will be assessed by the Patient Health Questionnaire-9 (PHQ-9). The scale ranges from 0 to 27, with higher scores indicating more severe depression.	3 months
Secondary	anxiety	Anxiety will be assessed by the Generalized Anxiety Disorder-7 (GAD-7). The scale ranges from 0 to 21, with higher scores indicating more severe anxiety.	3 months
Secondary	well-being	Well-being will be assessed by the Flourishing Scale. The scale ranges from 8 to 56, with higher scores indicating greater psychological well-being.	3 months
Secondary	Pain Resilience	Pain resilience will be assessed by the Pain Resilience Scale (PRS). The scale ranges from 0 to 56, with higher scores indicating greater resilience to pain.	3 months