An Emotional Regulation Brief Procedure (PbRE) for Fibromyalgia Using ICT's

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Emotional Regulation Brief Procedure for Fibromyalgia, Through the Internet

Conditions
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Fibromyalgia, Chronic Pain

Intervention / Treatment
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* Behavioral: PBrE
* Behavioral: PBrE-Control
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Had any mental disorder treated by a psychiatrist Were scheduled for surgery in the next 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental PBrE<br>Participants are exposed to several words of emotional contents (positive, and negative). The differences between these words will allow the regulation and counter regulation of emotional processes (Schwager y Rothermund, 2013). The words are related to clinical and personal characteristics of the patients and they will promote an emotional identification that improve the emotional regulation (Kashdan, Barret y McKnight, 2015). | Behavioral: PBrE<br>* 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.<br>|
| Placebo Comparator: Control PBrE<br>Participants are exposed to several neutral words. These words do not have any emotional content and there are no reasons to think that they have any effect over the emotional regulation. | Behavioral: PBrE-Control<br>* Participants are exposed to several neutral words. These words do not have any emotional content and there are no reasons to think that they have any effect over the emotional regulation.<br>|
| Other: Control<br>Participants do not receive the intervention. | Behavioral: Control<br>* Participants do not receive the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Index of Severity in Fibromyalgia (ICAF). Change is being assessed | 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. | Through study completion, an average of 1 year | 
| Fibromyalgia Impact Questionnaire (FIQ). Change is being assessed | 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. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQol-5D-5L | The EuroQol-5D-L questionnaire (Herdman et al., 2011) is divided into 2 sections. The first section contains 5 questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Five levels for answering are included (no problems, slight problems, moderate problems, severe problems and extreme problems), ranging from 1 to 5. The second part is a VAS score, which records the responder's self-evaluated health, where 0 is worst imaginable health and 100 is best imaginable health. | Through treatment completion, an average of 6 weeks | 
| Credibility and Expectancy Questionnaire (CEQ) | Patients' expectancy of treatment will be assessed with the Credibility and Expectancy Questionnaire (CEQ) (Devilly and Borkovec, 2010). Both factors (credibility and expectancy) have been shown to be stable across different populations with high internal consistency within each factor. The scale consists of six questions, with answer options rated on a 10-point scale and on a 1-100 % scale. | Through treatment completion, an average of 6 weeks | 
| Client Satisfaction Questionnaire | The Client Satisfaction Questionnaire, in its 8-item version (CSQ-8; Larsen et al. 1979), has been used most commonly to assess satisfaction in mental health services. This tool includes a brief standardized scale with good psychometric properties that provides an overall assessment of satisfaction. We used the Spanish version of the CSQ-8 (Vázquez et al., 2017). | Through treatment completion, an average of 6 weeks | 
| Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale (PCS) (Sullivan, Bishop, & Pivik, 1995) is a 13-item scale used to assess pain catastrophizing. Participants rated the frequency of 13 negative pain-related thoughts and feelings on a 5-point Likert scale from 0 (not at all) to 4 (all the time). The range of scores is 0 to 54. Higher scores indicate greater catastrophizing. We used the Spanish version of the PCS (García Campayo et al., 2008). | Through study completion, an average of 1 year | 
| Acceptance and Action Questionnaire - II | Acceptance and Action Questionnaire - II (Bond et al., 2011; Ruiz, et al., 2013). The AAQ-II is a general measure of experiential avoidance and psychological inflexibility. It consists of 7 items which are responded to by using a 7-point Likert scale. The items reflect an unwillingness to experience unwanted emotions and thoughts. | Through study completion, an average of 1 year | 
| Short Form 12 Health Survey | The Short Form 12 Health Survey (SF-12) (Vilagut et al., 2008; Ware & Keller, 1996) is a generic instrument used to assess health-related quality of life. It is a self-report survey of 12 items grouped into eight dimensions: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role and mental health. The score ranges from 0 to 100 for every scale, where higher scores indicate better health. | Through study completion, an average of 1 year | 
| Emotion Regulation Questionnaire | The Emotion Regulation Questionnaire (Gross & John, 2003; Cabello, Salgero, Fernández-Berrocal & Gross, 2013) consist of 10 items which are responded to by using a 7-point Likert scale. The items are grouped into two dimensions: cognitive reappraisal and expressive suppression. | Through study completion, an average of 1 year |