Chronic Migraine HeadacheMIG-PSY-CGRPNCT07877493
Psychological Support for Chronic Migraine Patients Treated With Anti-CGRP (Anti-Calcitonin Gene-Related Peptide ) Monoclonal Antibodies
An observational study of Chronic Migraine Headache and Psychologic Adaptation, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Chronic migraine is a disabling neurological condition that can significantly affect quality of life, emotional well-being, social participation, and daily functioning. Although anti-CGRP monoclonal antibodies have substantially improved migraine management for many patients, little is known about the psychological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine Headache, Psychologic Adaptation
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Oct 2026
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: • Missing data required to determine therapeutic response status.
Who may be able to join
- • Diagnosis of chronic migraine established by a neurologist.
- Treatment with an anti-CGRP monoclonal antibody administered at the CHRU de Nancy.
- Completion of the initial psychological interview.
- Availability of analyzable clinical and psychological data.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHRU
Nancy, 54000
laure barbe, clinical psychologist, +33 3 83 85 98 16, l.barbe@chru-nancy.fr
Claire HOUARD, clinical psychologist
About this study
Official title: Psychological Adjustment Following Extreme Therapeutic Responses to Anti-Calcitonin Gene-Related Peptide (CGRP) Treatment in Patients With Chronic Migraine: A Mixed Quantitative and Qualitative Study
Chronic migraine is a disabling neurological condition that can significantly affect quality of life, emotional well-being, social participation, and daily functioning. Although anti-CGRP monoclonal antibodies have substantially improved migraine management for many patients, little is known about the psychological experiences and adjustment processes associated with these treatments.
This observational study aims to explore the psychological adaptation of adults with chronic migraine treated with anti-CGRP monoclonal antibodies. Participants will complete standardized questionnaires assessing migraine-related disability, headache impact, anxiety and depressive symptoms, quality of life, and treatment experiences at treatment initiation and after 12 months of follow-up. Psychological interviews will also be conducted to explore patients' perceptions, coping strategies, and lived experiences of treatment.
The study seeks to identify factors associated with positive or negative psychological adaptation to treatment and to better understand patients' emotional experiences throughout their care pathway. The findings may contribute to the development of tailored psychological support interventions for individuals living with chronic migraine.
Read the detailed description
This single-center, retrospective, observational study combines quantitative and qualitative methodologies. The study will be conducted at the CHRU de Nancy and will include approximately 30 adults with chronic migraine treated with anti-CGRP monoclonal antibodies as part of routine clinical care.
At the study site, patients receiving anti-CGRP monoclonal antibody therapy routinely undergo a psychological interview at treatment initiation and follow-up psychological assessments during their care. Clinical and psychological data will be retrospectively collected from medical records, psychological interview reports, and standardized questionnaires administered at baseline (T0) and after 12 months of treatment (T1).
Quantitative assessment will include measures of anxiety and depressive symptoms using the Hospital Anxiety and Depression Scale (HADS), headache impact using the Headache Impact Test (HIT-6), and migraine-related disability using the Migraine Disability Assessment Scale (MIDAS).
The primary analysis will compare HADS total scores as well as HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) scores between two groups of participants defined according to their perceived treatment efficacy after 12 months of anti-CGRP therapy: a "Marked Improvement" group and a "No Perceived Efficacy" group. Secondary analyses will evaluate changes in HIT-6 and MIDAS scores between baseline and 12 months of follow-up.
Qualitative analysis will explore patients' psychological experiences of treatment, including emotional adjustment, coping strategies, adaptation to chronic pain, psychosocial functioning, expectations regarding treatment, changes in occupational, social, family, and leisure activities, and perceived needs for psychological support.
Comparative thematic analyses will be conducted between participants reporting marked improvement and those reporting no perceived efficacy in order to identify psychological factors, experiences, and coping processes associated with different treatment perceptions and adaptation trajectories.
The study aims to improve understanding of the psychological dimensions of chronic migraine treatment with anti-CGRP monoclonal antibodies and to identify factors that may inform the development of tailored psychological support for patients living with chronic migraine.
- Conditions
- Chronic Migraine Headache, Psychologic Adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Marked Improvement Group Patients showing a highly favorable response to anti-CGRP treatment. | Not described | |
| No Perceived Efficacy Group Patients reporting no perceived efficacy following anti-CGRP treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS) total, anxiety, and depression scores
- Psychological distress assessed using the Hospital Anxiety and Depression Scale (HADS). The scale includes a total score and two subscales: anxiety (HADS-A) and depression (HADS-D). Scores range from 0 to 21 for each subscale, with higher scores indicating greater anxiety or depressive symptoms. Participants are assessed at baseline (T0) and at 12 months (T1). Changes in HADS total score and/or HADS-A and HADS-D scores will be compared between participants reporting marked improvement of migraine and those reporting no perceived treatment efficacy.The total HADS score ranges from 0 to 42, with higher scores indicating greater overall psychological distress.
Measured: From baseline (first anti-CGRP infusion) to 12 months
Secondary outcomes (7)
Headache impact measured with the Headache Impact Test-6 (HIT-6)
- The Headache Impact Test-6 (HIT-6) assesses the impact of headaches on daily functioning. Scores range from 36 to 78, with higher scores indicating a greater impact of headache on quality of life. Assessments are performed at baseline (T0) and 12 months (T1).
Measured: From baseline (first anti-CGRP infusion) to 12 months
Migraine-related disability measured with the Migraine Disability Assessment Scale (MIDAS)
The Migraine Disability Assessment Scale (MIDAS) evaluates migraine-related disability. Scores range from 0 to 270, with higher scores indicating greater migraine-related disability. Assessments are performed at baseline (T0) and 12 months after treatment initiation (T1).
Measured: From baseline (first anti-CGRP infusion) to 12 months
Themes identified during psychological interviews
Semi-structured psychological interviews conducted at baseline (T0) and 12 months (T1) wille be reviewed using thematic analysis. Recurring themes related to participants 'experiences of anti-CGRP monoclonal antibody treatment will be identified from interview notes and reported descriptively.
Measured: Baseline (T0) and 12 months (T1)
Changes in occupational, social, and leisure activities
Qualitative assessment of changes in occupational functioning, social participation, and leisure activities reported during psychological interviews between baseline (T0) and 12 months (T1).
Measured: Baseline (T0) and 12 months (T1)
Coping strategies reported during psychological interviews
Qualitative evaluation of coping strategies used by participants in relation to chronic migraine and its treatment, identified through semi-structured psychological interviews conducted at baseline (T0) and 12 months (T1).
Measured: Baseline (T0) and 12 months (T1)
Self-reported need for additional psychological support
Participants report whether additional psychological support is needed during the study period. Information is collected through psychological interviews at baseline (T0) and 12 months (T1).
Measured: Baseline (T0) and 12 months (T1)
Presence of psychotraumatic experiences reported during psychological interviews
Identification of current or past psychotraumatic experiences reported by participants during semi-structured psychological interviews conducted at baseline (T0) and 12 months (T1). Information documented in interview notes will be reviewed qualitatively and reported descriptively.
Measured: Baseline (T0) and 12 months (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine HeadacheStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BARBE Laure, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877493
- Sponsor's protocol ID
- 2026PI186
- Acronym
- MIG-PSY-CGRP
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and because data sharing is not included in the study protocol.