Emotional Regulation Brief Procedure for Fibromyalgia, Through the Internet
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Combined Index of Severity in Fibromyalgia (ICAF). Change is being assessed
研究概览
简要总结
The study aims is to test the efficacy of an emotional regulation procedure for fibromyalgia patients using Information and Communications Technologies (ICTs). This procedure is based in a task that implies exposition to emotional words. The principal hypothesis is that exposition will improve the clinical symptomatology because the procedure restore an adequate emotional regulation.
详细描述
Previous studies have demonstrated that FM patients have difficulties to process emotional words when they are compared to normal subjects (Mercado et al., 2013). This dysfunctional emotion regulation could show attentional bias and it could be a way to increase FM symptomatology as pain, and fatigue (Duscheck et al., 2014).
The emotion generation and its regulation through an experimental task as reading words is a well stablished procedure (Lang, Bradley y Cuthbert, 1997). This paradigm has been shown efficacy in clinical context, to reduce anxiety in social phobia (Masia et al., 1999; Baños, Quero y Botella, 2008), generalized anxiety disorders (Fracalanza, Kroner y Antony, 2014), personality disorders (Arntz et al., 2012), and depression (Chuang et al., 2016). To address the gap between the experimental results of this form of emotional regulation in FM patients, and its clinical application, the aim of this study is to evaluate the efficacy of a Brief Procedure of Emotional Regulation for Fibromyalgia (PbRE)
PbRE is a word reading task implementing through an App developed for smartphones. The patient will choose emotional positive and negative words related to personal and clinical characteristics. This exercise has been shown useful in analogous tasks in relational frame theory (Hussey y Barnes-Holmes (2012) or in bias computer training (Salemink et al., 2014).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met the American College of Rheumatology (ACR) 2010 research classification criteria for FM (Wolfe et al., 2010, 2011); as confirmed by a rheumatologist
- •A minimum of 18 years of age
- •Showed adequate reading comprehension
- •Were able to use a smartphone
- •Were able to sign an informed consent form.
排除标准
- •Had any mental disorder treated by a psychiatrist
- •Were scheduled for surgery in the next 3 months.
结局指标
主要结局
Combined Index of Severity in Fibromyalgia (ICAF). Change is being assessed
时间窗: Through study completion, an average of 1 year
The Combined Index of Severity in Fibromyalgia (ICAF) is a questionnaire that allows the classification of patients by severity in clinical practice. This analysis is a self-report questionnaire of 59 items constructed with the most common clinical manifestations of FM (Vallejo, Rivera, \& Esteve-Vives, 2010). The ICAF questionnaire offers total scores, where higher scores indicate a more severe disease. This questionnaire also provides four factors: emotional, physical (pain, fatigue, sleep quality and functional capacity), active coping, and passive coping. Similar to the total score, higher scores on each factor indicate greater severity, with the exception of the active coping factor, where higher scores indicate a better way to cope with the disease.
Fibromyalgia Impact Questionnaire (FIQ). Change is being assessed
时间窗: Through study completion, an average of 1 year
The Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt, Clark, \& Bennett, 1991; Rivera \& González, 2004) is a self-report questionnaire designed to evaluate the impact of the FM on the life of the patient. This 10-item questionnaire is widely used and covers the principal areas of interest, including physical functioning, pain, sleep, mental health, and fatigue. The score ranges from 0 to 100, where higher scores indicate a more severe impact of the disease.
次要结局
- Credibility and Expectancy Questionnaire (CEQ)(Through treatment completion, an average of 6 weeks)
- Client Satisfaction Questionnaire(Through treatment completion, an average of 6 weeks)
- Pain Catastrophizing Scale (PCS)(Through study completion, an average of 1 year)
- Short Form 12 Health Survey(Through study completion, an average of 1 year)
- Emotion Regulation Questionnaire(Through study completion, an average of 1 year)
- EuroQol-5D-5L(Through treatment completion, an average of 6 weeks)
- Acceptance and Action Questionnaire - II(Through study completion, an average of 1 year)