An Emotional Regulation Brief Procedure (PbRE) for Fibromyalgia Using ICT's
NCT ID: NCT04084873
Last Updated: 2020-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-10-07
2021-10-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
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.
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.
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.
Control
Participants do not receive the intervention.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Were scheduled for surgery in the next 3 months.
18 Years
ALL
No
Sponsors
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Ministerio de Economía y Competitividad, Spain
OTHER_GOV
Universidad Nacional de Educación a Distancia
OTHER
Responsible Party
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Locations
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Miguel A. Vallejo
Madrid, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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iTCC55
Identifier Type: -
Identifier Source: org_study_id