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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084873
Recruitment Status : Unknown
Verified November 2020 by Universidad Nacional de Educación a Distancia.
Recruitment status was:  Enrolling by invitation
First Posted : September 10, 2019
Last Update Posted : November 6, 2020
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Universidad Nacional de Educación a Distancia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Pain Behavioral: PBrE Behavioral: PBrE-Control Behavioral: Control Not Applicable

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emotional Regulation Brief Procedure for Fibromyalgia, Through the Internet
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Experimental PBrE
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
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.

Placebo Comparator: Control PBrE
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
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.

Control
Participants do not receive the intervention.
Behavioral: Control
Participants do not receive the intervention.




Primary Outcome Measures :
  1. Combined Index of Severity in Fibromyalgia (ICAF). Change is being assessed [ Time Frame: 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.

  2. Fibromyalgia Impact Questionnaire (FIQ). Change is being assessed [ Time Frame: 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.


Secondary Outcome Measures :
  1. EuroQol-5D-5L [ Time Frame: Through treatment completion, an average of 6 weeks ]
    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.

  2. Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: Through treatment completion, an average of 6 weeks ]
    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.

  3. Client Satisfaction Questionnaire [ Time Frame: Through treatment completion, an average of 6 weeks ]
    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).

  4. Pain Catastrophizing Scale (PCS) [ Time Frame: Through study completion, an average of 1 year ]
    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).

  5. Acceptance and Action Questionnaire - II [ Time Frame: Through study completion, an average of 1 year ]
    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.

  6. Short Form 12 Health Survey [ Time Frame: Through study completion, an average of 1 year ]
    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.

  7. Emotion Regulation Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084873


Locations
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Spain
Miguel A. Vallejo
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Nacional de Educación a Distancia
Ministerio de Economía y Competitividad, Spain
Publications:

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Responsible Party: Universidad Nacional de Educación a Distancia
ClinicalTrials.gov Identifier: NCT04084873    
Other Study ID Numbers: iTCC55
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases