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

Last updated: November 5, 2020
Sponsor: Universidad Nacional de Educación a Distancia
Overall Status: Active - Enrolling

Phase

N/A

Condition

Pain

Chronic Pain

Fibromyalgia

Treatment

N/A

Clinical Study ID

NCT04084873
iTCC55
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Met the American College of Rheumatology (ACR) 2010 research classification criteriafor 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

Exclusion Criteria:

  • Had any mental disorder treated by a psychiatrist
  • Were scheduled for surgery in the next 3 months.

Study Design

Total Participants: 50
Study Start date:
October 07, 2019
Estimated Completion Date:
October 31, 2021

Study 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).

Connect with a study center

  • Miguel A. Vallejo

    Madrid, 28040
    Spain

    Site Not Available

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