跳至主要内容
临床试验/NCT05658185
NCT05658185已完成不适用

Migraine Difficult to Treat: the Importance of Psychological Care in the Chronic Patient

University of Valencia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change Emotional Distress Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Failure to meet the inclusion criteria

研究组 & 干预措施

No Intervention: Control Group

No Intervention

All patients will be evaluated on 4 occasions: 1) T1: 1st pre-treatment measurement in control and experimental groups; 2) after 10 weeks, T2: 2nd pre-treatment measurement in control and experimental groups; 3) after 10 weeks, T3: 3rd pre-treatment measurement in control and experimental groups, and 1st post-treatment measurement in experimental groups. Between T2 and T3 the patients in the experimental group will receive for 10 weeks the 10 sessions of the psychological treatment protocol; 4) after that, in the following 10 weeks, the control group will receive the 10 sessions of psychological treatment, thus at T4: 1st post-treatment measurement in the control group, and 1st post-treatment follow-up session in the experimental group (during this time, the experimental group does not receive any more treatment sessions, but practices all the psychological management skills installed during the treatment protocol between T2 and T3).

Experimental Group

Experimental

All patients will be evaluated on 4 occasions: 1) T1: 1st pre-treatment measurement in control and experimental groups; 2) after 10 weeks, T2: 2nd pre-treatment measurement in control and experimental groups; 3) after 10 weeks, T3: 3rd pre-treatment measurement in control and experimental groups, and 1st post-treatment measurement in experimental groups. Between T2 and T3 the patients in the experimental group will receive for 10 weeks the 10 sessions of the psychological treatment protocol; 4) after that, in the following 10 weeks, the control group will receive the 10 sessions of psychological treatment, thus at T4: 1st post-treatment measurement in the control group, and 1st post-treatment follow-up session in the experimental group (during this time, the experimental group does not receive any more treatment sessions, but practices all the psychological management skills installed during the treatment protocol between T2 and T3).

干预措施: MIDITRA (Behavioral)

结局指标

主要结局

Change Emotional Distress Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.

时间窗: 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.

Assessment with Hospital Anxiety and Depression Scale in caregivers (HADS): Screening instrument for the detection of affective disorders, in non-psychiatric subjects who go to hospitals. The scale is made up of 14 items, with a range of scores from 0 to 42. The interpretation is that the higher the score, the greater the presence of anxiety-depressive symptoms.

Change in quality of life. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.

时间窗: 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.

Assessment with MSQ 21. (Migraine-Specific Quality of Life Questionnaire or MSQ)21 is a migraine-specific questionnaire designed to assess limitations in quality of life and the effect of treatments.

Change in Perception of psychological stress. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.

时间窗: 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.

Assessment with EEP-10. The Spanish version of the EEP-10 used by Remor in a validation study with adults in Spain was used. The scale includes a series of direct queries that explore the level of stress experienced during the last month. The items are easily understood. The scale provides five response options: 'never', 'hardly ever', 'occasionally', 'many times' and 'always', which are ranked from zero to four.

次要结局

  • Change in Resilience. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.(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.)
  • Change in Disability due to migraine headaches. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.(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)
  • Change in Life Satisfaction Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.(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.)
  • Change in Negative impact of headache. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.(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)
  • Change in Catastrophizing to pain. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.(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.)
  • Change in Positive and negative affect. Baseline T1, Baseline T2-Pre, Post-Treatment T3 and Follow-up T4.(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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

M. Antonia Pérez-Marín

PhD in Psychology

University of Valencia

研究点 (2)

Loading locations...

相似试验