Expectancies in Migraine Patients

NCT06633991 | Completed DMC

• 1 other identifier: EXPMI
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to examine whether the standard treatment prescribed to migraine patients is potentiated when coupled with a verbal instruction inducing more hope and optimism. In order to achieve the goal, outpatients with low-frequency episodic migraine diagnoses (\<8 attacks per month) and outpatients with chronic migraine diagnoses (\>15 attacks per month) will be screened and enrolled, thereafter they will be exposed to verbal instruction inducing more hope and optimism or to verbal instruction inducing hope and optimism together with standard treatment. We hypothesize that the group receiving verbal instruction inducing more hope and optimism would develop larger improvements in all outcome measures.

Conditions

Migraine

Keywords

expectations; placebo effect; migraine; verbal instrucitons

Outcome Measures

Primary Outcomes (2)

• Headache Impact Test

  self-report scale assessing the disability due to migraine

  baseline, 7-day, 15-day, 1- and 3-month follow-ups

• Intensity of migraine

  A Numeric Rating Scale (NRS) assessing the intensity of migraine pain on a 11-point NRS (0 = no pain, 10 = worst imaginable pain) during the last migraine attack

  baseline, 7-day, 15-day, 1- and 3-month follow-ups

Secondary Outcomes (1)

• Expectancies

  baseline, 7-day, 15-day, 1- and 3-month follow-ups

Study Arms (2)

instructions inducing hope and optimism

EXPERIMENTAL

The verbal instruction inducing more hope and optimism will be: "The present therapy is a very effective one for your specific type of headache. By taking it, a large number of patients experienced significant pain relieve and improvement in functional capacity

Procedure: verbal instructions

neutral instructions

PLACEBO COMPARATOR

The verbal instruction inducing hope and optimism will be: "The present therapy is an effective one for your specific type of headache. By taking it, a large number of patients experienced pain relieve and improvement in functional capacity".

Procedure: verbal instructions

Interventions

verbal instructions PROCEDURE

verbal instructions inducing hope and optimism were administered as experimental condition vs neutral instructions (i.e., instructions not able to induce hope and optimism although realistic ones)

Also known as: verbal instrucitons

instructions inducing hope and optimism; neutral instructions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incident or prevalent diagnosis of low-frequency episodic migraine or chronic migraine according to ICHD criteria version 3 beta 2013.
• Age of at least 18 years.
• Signature of informed consent.

You may not qualify if:

• Standard treatment proposed different from topiramate, amitriptyline, valproate, β-blockers.
• Inability to understand and want.

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Fiammetta COSCI

Florence, 50135, Italy

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants did not know whether they were allocated to the control or the experimental condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: control vs experiemntal condition

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)