Clinical trial NCT04084873: An Emotional Regulation Brief Procedure (PbRE) for Fibromyalgia Using ICT's
Official title: Emotional Regulation Brief Procedure for Fibromyalgia, Through the Internet
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2019-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: Combined Index of Severity in Fibromyalgia (ICAF). Change is being assessed
timeFrame: Through study completion, an average of 1 year
measure: Fibromyalgia Impact Questionnaire (FIQ). Change is being assessed
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: EuroQol-5D-5L
timeFrame: Through treatment completion, an average of 6 weeks
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Through treatment completion, an average of 6 weeks
measure: Client Satisfaction Questionnaire
timeFrame: Through treatment completion, an average of 6 weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Through study completion, an average of 1 year
measure: Acceptance and Action Questionnaire - II
timeFrame: Through study completion, an average of 1 year
measure: Short Form 12 Health Survey
timeFrame: Through study completion, an average of 1 year
measure: Emotion Regulation Questionnaire
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Miguel A. Vallejo
Study officials:
References:
citation: Arntz A, Hawke LD, Bamelis L, Spinhoven P, Molendijk ML. Changes in natural language use as an indicator of psychotherapeutic change in personality disorders. Behav Res Ther. 2012 Mar;50(3):191-202. doi: 10.1016/j.brat.2011.12.007. Epub 2012 Jan 4.
citation: Bennett MP, Meulders A, Baeyens F, Vlaeyen JW. Words putting pain in motion: the generalization of pain-related fear within an artificial stimulus category. Front Psychol. 2015 Apr 30;6:520. doi: 10.3389/fpsyg.2015.00520. eCollection 2015.
citation: Duschek S, Werner NS, Limbert N, Winkelmann A, Montoya P. Attentional bias toward negative information in patients with fibromyalgia syndrome. Pain Med. 2014 Apr;15(4):603-12. doi: 10.1111/pme.12360. Epub 2014 Jan 21.
citation: Mercado F, Gonzalez JL, Barjola P, Fernandez-Sanchez M, Lopez-Lopez A, Alonso M, Gomez-Esquer F. Brain correlates of cognitive inhibition in fibromyalgia: emotional intrusion of symptom-related words. Int J Psychophysiol. 2013 May;88(2):182-92. doi: 10.1016/j.ijpsycho.2013.03.017. Epub 2013 Apr 2.
citation: Montoya P, Sitges C, Garcia-Herrera M, Izquierdo R, Truyols M, Blay N, Collado D. Abnormal affective modulation of somatosensory brain processing among patients with fibromyalgia. Psychosom Med. 2005 Nov-Dec;67(6):957-63. doi: 10.1097/01.psy.0000188401.55394.18.
citation: Schwager S, Rothermund K. Counter-regulation triggered by emotions: positive/negative affective states elicit opposite valence biases in affective processing. Cogn Emot. 2013;27(5):839-55. doi: 10.1080/02699931.2012.750599. Epub 2012 Dec 14.