Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05658185
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2022-11-01
Brief Title:
Migraine Difficult to Treat the Importance of Psychological Care in the Chronic Patient
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Migraine Difficult to Treat the Importance of Psychological Care in the Chronic Patient
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIDITRA
Brief Summary:
In the study of migraine headaches it is important to consider the affectation presented by those patients whose migraines do not respond easily to treatment These difficult to treat patients are more likely to develop chronic headache facilitating the appearance of psychological problems associated with this disease Holistic care of these patients includes the disability caused by pain the impact of pain on their lives the level of pain catastrophizing perceived psychological well-being quality of life and emotional distress The quality of life of these patients is often severely affected and the psychoemotional symptoms are significantly elevated The psychological impact associated with these difficult-to-treat chronic migraine patients is a neglected issue in current mental health care Investigators propose to design a protocol for the evaluation and psychological treatment of these patients based on cognitive-behavioral theory After that the psychological treatment of 10 group sessions will be implemented in a pilot sample It will have 4 evaluation moments to be able to quantify by means of questionnaires the progress of the patients in the different stages of the study The aim is to achieve an increase in the quality of life and a decrease in the interference of migraines in the patients lives
Detailed Description:
Chronic diseases CD are characterized by their long duration unpredictable changes in their course in the persons appearance limitations in physical capacity prolonged dependence on medical specialists continuous treatments and need for assistance
Migraine is a neurological disorder characterized by episodic and recurrent attacks which usually present with headache usually associated with hypersensitivity to external stimuli visual auditory olfactory and cutaneous nausea and vomiting Migraine can be considered as a chronic process Within this category CM is diagnosed in persons in whom migraine attacks appear at least 15 days per month in the last three months and in whom the headache and associated symptoms correspond to migraine attacks on at least 8 days per month They are then said to suffer from chronic migraine CM CM is considered to be the result of an increase in headache frequency over months or years in a process called migraine transformation or chronification CM usually affects people of productive age causes great individual and social costs and is associated with numerous comorbidities Its usual treatment includes control measures to avoid migraine triggers modification of risk factors and administration of pharmacological and non-pharmacological treatments which both address and prevent attacks
The prevalence of migraine in Western countries is between 10-16 with a predominance in women of 2-318 more than double in women According to the WHO migraine affects 6 of men and 18 of women and is the sixth most disabling disease in the world taking into account the quality of life lost during the episodes which in the most severe cases can involve constant pain for more than 15 days a month These extremes affect one man for every eight women This fact is one of the reasons why the disease has been stigmatized for so long Evolutionarily 25-3 of patients with episodic migraine EM develop CM annually
These data point to the importance of knowing which factors can increase the risk of chronification and aggravation of the migraine patient Knowing these factors allows us to better understand the mechanisms involved in the perpetuation of pain so that investigators can act on them to modify the course of migraine and improve the quality of life of these patients The risk factors related to these patients have been divided into three groups10-14 non-modifiable modifiable and other factors
Among the risk factors for chronification and aggravation in migraine patients investigators would like to point out those that the literature indicates as modifiable highlighting significantly the impact of aspects such as stressful life events sleep disorders degree of disability caused by migraines impact of the headache on daily life level of catastrophizing about the pain perception of psychological well-being perceived quality of life and level of existing emotional distress anxiety depression stress
It is often difficult to treat patients with CM pharmacologically and obtain satisfactory results for them Within the existing medical therapeutic possibilities it is necessary to help the patient to form real expectations of the efficacy and safety of each treatment as well as the possibilities they offer to control their disease In this regard there are very few studies in the scientific literature that apply psychological care protocols in this particular type of chronic patients with CM with clinical symptoms resistant to improvement There is research related to chronic pain in other types of clinical conditions back pain pain associated with neoplasms but it is very scarce in patients with chronic resistant migraine
Migraine is a neurological disorder characterized by episodic and recurrent attacks which usually present with headache usually associated with hypersensitivity to external stimuli visual auditory olfactory and cutaneous nausea and vomiting Migraine can be considered as a chronic process Within this category CM is diagnosed in persons in whom migraine attacks appear at least 15 days per month in the last three months and in whom the headache and associated symptoms correspond to migraine attacks on at least 8 days per month They are then said to suffer from chronic migraine CM CM is considered to be the result of an increase in headache frequency over months or years in a process called migraine transformation or chronification CM usually affects people of productive age causes great individual and social costs and is associated with numerous comorbidities Its usual treatment includes control measures to avoid migraine triggers modification of risk factors and administration of pharmacological and non-pharmacological treatments which both address and prevent attacks
The prevalence of migraine in Western countries is between 10-16 with a predominance in women of 2-318 more than double in women According to the WHO migraine affects 6 of men and 18 of women and is the sixth most disabling disease in the world taking into account the quality of life lost during the episodes which in the most severe cases can involve constant pain for more than 15 days a month These extremes affect one man for every eight women This fact is one of the reasons why the disease has been stigmatized for so long Evolutionarily 25-3 of patients with episodic migraine EM develop CM annually
These data point to the importance of knowing which factors can increase the risk of chronification and aggravation of the migraine patient Knowing these factors allows us to better understand the mechanisms involved in the perpetuation of pain so that investigators can act on them to modify the course of migraine and improve the quality of life of these patients The risk factors related to these patients have been divided into three groups10-14 non-modifiable modifiable and other factors
Among the risk factors for chronification and aggravation in migraine patients investigators would like to point out those that the literature indicates as modifiable highlighting significantly the impact of aspects such as stressful life events sleep disorders degree of disability caused by migraines impact of the headache on daily life level of catastrophizing about the pain perception of psychological well-being perceived quality of life and level of existing emotional distress anxiety depression stress
It is often difficult to treat patients with CM pharmacologically and obtain satisfactory results for them Within the existing medical therapeutic possibilities it is necessary to help the patient to form real expectations of the efficacy and safety of each treatment as well as the possibilities they offer to control their disease In this regard there are very few studies in the scientific literature that apply psychological care protocols in this particular type of chronic patients with CM with clinical symptoms resistant to improvement There is research related to chronic pain in other types of clinical conditions back pain pain associated with neoplasms but it is very scarce in patients with chronic resistant migraine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None