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

Universidad Nacional de Educación a Distancia

Status: Unknown

Conditions: Fibromyalgia; Chronic Pain

Treatments: Behavioral: PBrE; Behavioral: PBrE-Control; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04084873

iTCC55

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 3 patient groups, including a placebo group

Experimental PBrE

Experimental group

Description:

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).

Treatment:

Behavioral: PBrE

Control PBrE

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: PBrE-Control

Control

Other group

Description:

Participants do not receive the intervention.

Treatment:

Behavioral: Control