Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633991
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Expectancies in Migraine Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Expectancies About Positive Outcomes and Their Possible Potentiating Role of Standard Treatment in Migraine Patients
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPMIG
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
Detailed Description:
Study design and sample Cohort study with longitudinal detection of the endpoints of interest for the study See section Instruments
Among the new patients or outpatients already assisted at the SOD Center Headache and Clinical Pharmacology of the University Hospital AOU Careggi the candidates eligible for participation will be identified according to the inclusion and exclusion criteria listed below and participation will be proposed Patients who after being informed will consent through explicit and written informed consent to participate in the study will be enrolled A total of 100 subjects will be enrolled Each participant will be able to withdraw the consent for participation at any time without providing justification The request will invariably be accepted and the subjects data will be excluded from the study
Inclusion criteria for cases
1 Incident or prevalent diagnosis of low-frequency episodic migraine or chronic migraine according to ICHD criteria version 3 beta 2013
2 Age of at least 18 years
3 Signature of informed consent
Exclusion criteria for cases
1 Standard treatment proposed different from topiramate amitriptyline valproate β-blockers
2 Inability to understand and want
Procedure Migraine patients will receive a baseline assessment aimed at formulating or confirming the diagnosis of migraine based on a specific set of questions that doctors of the SOD Center of Headache and Clinical Pharmacology use routinely The doctors of the SOD Center of Headache and Clinical Pharmacology will inform migraine patients about the purposes and procedures of the study and will gather consent to participate in the study by them Consent will be explicitly issued by signing a specific form Thereafter a psychologist will collect socio-demographic information information relating to the pharmacological and non-pharmacological treatment in progress information relating to the history of organic disease based on a set of questions already used in the past The interview will take about 30 minutes Then doctors of the SOD Center of Headache and Clinical Pharmacology will formulate the standard prescription based on their routine practice Such prescription will be coupled to a verbal instruction inducing more hope and optimism or to a verbal instruction inducing hope and optimism according to a random assignment Block randomization of size two will be used The allocation schedule will be created centrally by an independent researcher using a computerized random number generator the other investigators will be blinded to the schedule
The entire study will last 12 months Each subject will be assessed before starting the treatment ie baseline and at 7-day 15-day 1-month 2-month and 3-month follow-ups Each subject will be asked to devote about two hours to the participation to the present study
Instruments Socio-demographic information information regarding pharmacological and non-pharmacological treatment and information concerning the clinical history of organic pathology will be collected through a special set of questions already used in the past Participant data will be archived and processed only after appropriate anonymization Each subject will receive an alphanumeric code which will be the only identification code on the questionnaires The doctors of the SOD Center of Headache and Clinical Pharmacology will keep the documents in a special archive that will allow each patient to be associated with their own alphanumeric identification code This document will allow the possible deletion of a patients data if the patient makes an explicit request
Psychological variables will be measured using the following tools
Headache Impact Test HIT-6 this 6-item instrument was designed to provide a global measure of adverse headache and migraine impact on patients everyday life It is intended for use in screening and monitoring patients with headaches in both clinical practice and clinical research It includes 6 items measuring the adverse impact of headache on social functioning role functioning vitality cognitive functioning psychological distress and the severity of headache pain The scoring ranges from 36 to 78 with a cutoff score of 50 The patient is asked to indicate the impact of headache in the past 4 weeks on a 6-point scale never rarely sometimes very often always Higher scores indicate a greater impact on the patients life
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
Assessment of expectancies about the effects of the treatment on migraine Before starting the treatment prescribed the patients expectancies of the reduction in migraine pain related to the treatment will be assessed asking the question Based on the intensity of migraine pain during the last migraine attack what intensity do you expect one week after the beginning of the new treatment The answer will be based on an 11-point NRS 0 no pain 10 worst migraine pain Expectancy will be computed as a difference value between the migraine pain of the last attack and the expected intensity in migraine pain one week after the beginning of the treatment Negative mean values will indicate that pain reduction is expected Positive values will indicate an expected increase in pain
The above instruments will be administered immediately before starting the drug treatment at 7 days 15 days 1 month 2 months 3 months
In addition at 7 days 15 days 1 month 2 months 3-month follow-ups the Kellners scale of change after treatment will be administered This is a 9-point NRS 9 much worse 1 much improved assessing the level of change of migraine pain over the time
Instructions 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 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
The instruction will be given at baseline
Among the new patients or outpatients already assisted at the SOD Center Headache and Clinical Pharmacology of the University Hospital AOU Careggi the candidates eligible for participation will be identified according to the inclusion and exclusion criteria listed below and participation will be proposed Patients who after being informed will consent through explicit and written informed consent to participate in the study will be enrolled A total of 100 subjects will be enrolled Each participant will be able to withdraw the consent for participation at any time without providing justification The request will invariably be accepted and the subjects data will be excluded from the study
Inclusion criteria for cases
1 Incident or prevalent diagnosis of low-frequency episodic migraine or chronic migraine according to ICHD criteria version 3 beta 2013
2 Age of at least 18 years
3 Signature of informed consent
Exclusion criteria for cases
1 Standard treatment proposed different from topiramate amitriptyline valproate β-blockers
2 Inability to understand and want
Procedure Migraine patients will receive a baseline assessment aimed at formulating or confirming the diagnosis of migraine based on a specific set of questions that doctors of the SOD Center of Headache and Clinical Pharmacology use routinely The doctors of the SOD Center of Headache and Clinical Pharmacology will inform migraine patients about the purposes and procedures of the study and will gather consent to participate in the study by them Consent will be explicitly issued by signing a specific form Thereafter a psychologist will collect socio-demographic information information relating to the pharmacological and non-pharmacological treatment in progress information relating to the history of organic disease based on a set of questions already used in the past The interview will take about 30 minutes Then doctors of the SOD Center of Headache and Clinical Pharmacology will formulate the standard prescription based on their routine practice Such prescription will be coupled to a verbal instruction inducing more hope and optimism or to a verbal instruction inducing hope and optimism according to a random assignment Block randomization of size two will be used The allocation schedule will be created centrally by an independent researcher using a computerized random number generator the other investigators will be blinded to the schedule
The entire study will last 12 months Each subject will be assessed before starting the treatment ie baseline and at 7-day 15-day 1-month 2-month and 3-month follow-ups Each subject will be asked to devote about two hours to the participation to the present study
Instruments Socio-demographic information information regarding pharmacological and non-pharmacological treatment and information concerning the clinical history of organic pathology will be collected through a special set of questions already used in the past Participant data will be archived and processed only after appropriate anonymization Each subject will receive an alphanumeric code which will be the only identification code on the questionnaires The doctors of the SOD Center of Headache and Clinical Pharmacology will keep the documents in a special archive that will allow each patient to be associated with their own alphanumeric identification code This document will allow the possible deletion of a patients data if the patient makes an explicit request
Psychological variables will be measured using the following tools
Headache Impact Test HIT-6 this 6-item instrument was designed to provide a global measure of adverse headache and migraine impact on patients everyday life It is intended for use in screening and monitoring patients with headaches in both clinical practice and clinical research It includes 6 items measuring the adverse impact of headache on social functioning role functioning vitality cognitive functioning psychological distress and the severity of headache pain The scoring ranges from 36 to 78 with a cutoff score of 50 The patient is asked to indicate the impact of headache in the past 4 weeks on a 6-point scale never rarely sometimes very often always Higher scores indicate a greater impact on the patients life
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
Assessment of expectancies about the effects of the treatment on migraine Before starting the treatment prescribed the patients expectancies of the reduction in migraine pain related to the treatment will be assessed asking the question Based on the intensity of migraine pain during the last migraine attack what intensity do you expect one week after the beginning of the new treatment The answer will be based on an 11-point NRS 0 no pain 10 worst migraine pain Expectancy will be computed as a difference value between the migraine pain of the last attack and the expected intensity in migraine pain one week after the beginning of the treatment Negative mean values will indicate that pain reduction is expected Positive values will indicate an expected increase in pain
The above instruments will be administered immediately before starting the drug treatment at 7 days 15 days 1 month 2 months 3 months
In addition at 7 days 15 days 1 month 2 months 3-month follow-ups the Kellners scale of change after treatment will be administered This is a 9-point NRS 9 much worse 1 much improved assessing the level of change of migraine pain over the time
Instructions 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 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
The instruction will be given at baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None