Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- duration of migraine attacks
研究概览
简要总结
Chronic migraine is a disabling type of migraine and is often resistant to treatment. Non-pharmacological interventions have been investigated as potential treatment although, unfortunately, the literature on their efficacy is poor and showed mixed results. Well-Being Therapy (WBT) is a brief psychotherapy which has shown efficacy in decreasing the relapse rates of depression in adults, in generalized anxiety disorder and in cyclothymia. It can be implemented to empower psychological well-being. The aim of the present study is to test the efficacy of WBT in a sample of patients with chronic migraine to verify if it reduces the disability due to migraine and distress, it increases the psychological well-being as well as the level of euthymia.
详细描述
Chronic migraine is a disabling type of migraine and is often resistant to treatment. Non-pharmacological interventions have been investigated as potential treatment although, unfortunately, the literature on their efficacy is poor and showed mixed results. The psychological interventions tested up to now are the Acceptance and Commitment Therapy and the Mindfulness. Well-Being Therapy (WBT) is a brief psychotherapy which has been manualized in 2016 and has shown efficacy in randomized clinical trials. It showed to be effective in decreasing the relapse rates of depression in adults, it showed to be effective in generalized anxiety disorder and in cyclothymia. Thus, psychological well-being can be implemented and empowered via a specific psychotherapy and this implementation might produce a protecting effect, thus favoring prevention. The aim of the present study is to test the efficacy of WBT in a sample of patients with chronic migraine. First the efficacy of WBT will be verified in terms of disability due to migraine. Then, the efficacy of WBT will be measured in terms of psychological well-being, euthymia, and distress. For this purpose, 30 chromic migraine outpatients will be enrolled in a randomized, controlled, open clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not be informed if they will receive the WBT or the control condition. Of course, after the end of the study they will receive this information and they will be told why they were blind.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able and interested in participating to the present research project, as proved by signed Informed consent;
- •18-65 years of age;
- •Italian mother tongue;
- •diagnosis of chronic migraine according to the International Classification of Headache Disorders. Thus, presenting specific features (i.e., unilateral and pulsating pain of moderate or severe intensity, which is aggravated or precipitated by routine physical activities and is combined with nausea and/or vomiting, photophobia, and phonophobia) and migraine headache on ≥ 15 days per month;
- •headache chronicity for a minimum of 1 year and pattern of headache symptoms stable for a period of at least 6 months;
- •no pharmacological therapy or dietary supplements use for chronic migraine OR pharmacological therapy/dietary supplement use for chronic migraine stable since at least 3 months;
- •psychotropic medication allowed only if stable since at least three months.
排除标准
- •diagnosis of medication overuse headache;
- •co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders (DSM) 5th edition as diagnosed via the MINI International Neuropsychiatric Interview;
- •co-occurrence of chronic unstable medical conditions;
- •being pregnant or lactating;
- •under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy);
- •any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.
研究组 & 干预措施
Well-being therapy
WBT will be used as the only non-pharmacological therapeutic strategy and 8 sessions will be delivered every other week with a duration of 60 minutes each. The manualized WBT will be used (Fava, 2016). Thus, the initial phase will be concerned with self-observation of psychological well-being. Once the instances of well-being will be properly recognized, the patient will be encouraged to identify thoughts, beliefs, and behaviors leading to premature interruption of well-being (intermediate phase). The final part will involve cognitive restructuring of dysfunctional dimensions of psychological well-being and meeting the challenge that optimal experiences may entail.
干预措施: Well-Being Therapy (Behavioral)
Control condition
The control condition will include 8 be-weekly sessions based on Lifestyle and well-being National Institute for health and Care Excellence (NICE) guidelines (https://www.nice.org.uk/guidance/lifestyle-and-wellbeing) and on World Health Organization 12 steps to healthy eating (http://www.euro.who.int/en/health-topics/disease-prevention/nutrition/a-healthy-lifestyle). These sessions will inform participants about well-being and which lifestyles can influence it.
干预措施: Control condition (Other)
结局指标
主要结局
duration of migraine attacks
时间窗: from baseline to 3-month follow up
duration of migraine attacks assessed via a daily self-report headache diary (higher the duration, higher the severity of migraine)
intensity of migraine attacks
时间窗: from baseline to 3-month follow up
intensity of migraine attacks assessed via a daily self-report headache diary (higher the intensity, higher the severity of migraine)
disability due to migraine
时间窗: from baseline to 3-month follow up
level of disability due to migraine assessed via the Migraine Disability Assessment Score (score from 0 to \>21, for total score \> 6 disability is clinically relevant)
frequency of migraine attacks
时间窗: from baseline to 3-month follow up
frequency of migraine attacks assessed via a daily self-report headache diary (higher the frequency, higher the severity of migraine)
次要结局
- level of psychological well-being(from baseline to 3-month follow up)
- the level of euthymia(from baseline to 3-month follow up)
- level of anxiety and depression(from baseline to 3-month follow up)
研究者
Fiammetta Cosci
Associate Professor in Clinical Psychology
University of Florence