An observational study in Chronic Migraine Headache and Psychologic Adaptation, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Central Hospital, Nancy, France · Observational
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.
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.
Central Hospital, Nancy, France is the lead sponsor of 796 studies on the registry; 187 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of chronic migraine established by a neurologist.
Exclusion Criteria:
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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.
Time frame: From baseline (first anti-CGRP infusion) to 12 months
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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline (T0) and 12 months (T1)
Plan to share: No — Individual participant data will not be shared to protect participant confidentiality and because data sharing is not included in the study protocol.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →