Clinical trial NCT05658185: Migraine Difficult to Treat: the Importance of Psychological Care in the Chronic Patient
Official title: Migraine Difficult to Treat: the Importance of Psychological Care in the Chronic Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Headache, Migraine
Keywords: Intervention study
psychopathology
coping illness
protective factors
risk factors
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Fe
First posted: 2022-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 person's 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 2-3/18 (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, 2.5-3% 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic migraine difficult to treat for at least 6 months.
* Be of legal age
* Sign the informed consent form

Exclusion Criteria:

* Failure to meet the inclusion criteria

Primary outcomes:
measure: Change Emotional Distress Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.
timeFrame: T1. Start T2.10 weeks after T1, T3. Evaluation 10 weeks after T2, after the intervention is finished. T4. Follow-up, 10 weeks after post-treatment.
measure: Change in Perception of psychological stress. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.
timeFrame: T1. Start T2.10 weeks after T1, T3. Evaluation 10 weeks after T2, after the intervention is finished. T4. Follow-up, 10 weeks after post-treatment.
measure: Change in quality of life. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.
timeFrame: T1. Start T2.10 weeks after T1, T3. Evaluation 10 weeks after T2, after the intervention is finished. T4. Follow-up, 10 weeks after post-treatment.
Secondary outcomes:
measure: Change in Disability due to migraine headaches. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.
timeFrame: T1. Assessment CG and EG; T2.After 10 weeks, assessment CG and EG; T3. After 10 weeks,EG follow-up and CG evaluation after program implementation assessment after intervention application in EG; T4: follow-up evaluation in experimental and post-treatment
measure: Change in Negative impact of headache. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.
timeFrame: T1. Assessment CG and EG; T2.After 10 weeks, assessment CG and EG; T3. After 10 weeks,EG follow-up and CG evaluation after program implementation assessment after intervention application in EG; T4: follow-up evaluation in experimental and post-treatment
measure: Change in Catastrophizing to pain. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.
timeFrame: T1. Start T2.10 weeks after T1, T3. Evaluation 10 weeks after T2, after the intervention is finished. T4. Follow-up, 10 weeks after post-treatment.
measure: Change in Life Satisfaction Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.
timeFrame: T1. Start T2.10 weeks after T1, T3. Evaluation 10 weeks after T2, after the intervention is finished. T4. Follow-up, 10 weeks after post-treatment.
measure: Change in Positive and negative affect. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.
timeFrame: T1. Start T2.10 weeks after T1, T3. Evaluation 10 weeks after T2, after the intervention is finished. T4. Follow-up, 10 weeks after post-treatment.
measure: Change in Resilience. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.
timeFrame: T1. Start T2.10 weeks after T1, T3. Evaluation 10 weeks after T2, after the intervention is finished. T4. Follow-up, 10 weeks after post-treatment.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Marián Pérez-Marín
state: Comunitat Valenciana
city: Valencia
country: Spain
facility: Marián Pérez-Marín
Study officials:
affiliation: Universitat de Valencia
name: Marián Pérez-Marín, PhD
role: PRINCIPAL_INVESTIGATOR
References: