Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial

Giovanni Mansueto, Francesco De Cesaris, Pierangelo Geppetti, Fiammetta Cosci*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Web of Science)

Abstract

BackgroundChronic migraine is a chronic medical condition associated with resistance to pharmacological treatment and poor benefits from the psychological interventions studied to date, including acceptance and commitment therapy or mindfulness. This manuscript describes the rationale and methods for a pilot feasibility study designed to (1) establish and (2) evaluate the feasibility and acceptability of research procedures and interventions to investigate whether well-being therapy improves outcomes relative to a control condition.MethodsThe current intervention will use a randomized controlled trial design, wherein 30 outpatients with chronic migraine will be randomized (1:1) to well-being therapy (n=15) or to a control condition (n=15). Primary outcomes include the level of disability caused by migraine and the frequency, duration, and intensity of migraine attacks; the secondary outcomes focus on anxiety, depression, psychological well-being, euthymia, and distress. Primary and secondary outcomes will be assessed at baseline, after sessions 4 and 8, and at 3-month follow-up. The Ethical Review Boards at the University-Hospital Careggi has approved the study (5th December 2017).DiscussionIdentifying medium-term interventions able to improve chronic migraine is relevant to manage this illness. The present randomized trial might represent a step forward for managing chronic migraine by means of psychological interventions.Trial registrationClinicalTrial.gov Identifier: NCT03404336. Registered on 19 January 2018.
Original languageEnglish
Article number561
Number of pages9
JournalTrials
Volume19
Issue number561
DOIs
Publication statusPublished - 16 Oct 2018

Keywords

  • chronic migraine
  • migraine
  • headache
  • well-being therapy
  • psychological well-being
  • psychotherapy
  • ASSESSMENT MIDAS QUESTIONNAIRE
  • COGNITIVE-BEHAVIOR THERAPY
  • SYMPTOM QUESTIONNAIRE
  • RECURRENT DEPRESSION
  • CLINICAL-TRIALS
  • HEADACHE
  • MINDFULNESS
  • DISORDER
  • TENSION
  • RELAXATION

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