Evidence map›Paper›PMID 30326932›Full record

ArticleTrials2018

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03404336 (Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03404336 narecruitingnot on this map

Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients

TypeinterventionalSponsorUniversity of FlorenceRan2018 to 2026Enrolled30ConditionsChronic MigraineArmsWell-Being Therapy, Control condition
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Well-being Therapy in Depressive Disorders.Advances in experimental medicine and biology · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Giovanni MansuetoDepartment of Health Sciences, University of Florence, via di San Salvi 12, 50135, Florence, Italy.
Francesco De CesarisHeadache and Clinical Pharmacology Center, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Pierangelo GeppettiDepartment of Health Sciences, University of Florence, via di San Salvi 12, 50135, Florence, Italy.
Fiammetta CosciDepartment of Health Sciences, University of Florence, via di San Salvi 12, 50135, Florence, Italy. fiammetta.cosci@unifi.it.
Azienda Ospedaliero-Universitaria Careggi · ITMaastricht University · NLUniversity of Florence · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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). DISCUSSION: Identifying 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.

Indexed as

AdolescentAdultAgedChronic DiseaseFeasibility StudiesFemaleHealth StatusHumansItalyMaleMental HealthMiddle AgedMigraine DisordersPilot ProjectsPsychotherapyQuality of Lifechronic migraineheadachemigrainepsychological well-beingpsychotherapywell-being therapy

Identifiers

PMID30326932
PMCPMC6192307
OpenAlexW2897519016

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.