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

NCT04084873 | Unknown

• 1 other identifier: iTCC55
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Combined Index of Severity in Fibromyalgia (ICAF). Change is being assessed

  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.

  Through study completion, an average of 1 year

• Fibromyalgia Impact Questionnaire (FIQ). Change is being assessed

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (7)

• EuroQol-5D-5L

  Through treatment completion, an average of 6 weeks

• Credibility and Expectancy Questionnaire (CEQ)

  Through treatment completion, an average of 6 weeks

• Client Satisfaction Questionnaire

  Through treatment completion, an average of 6 weeks

• Pain Catastrophizing Scale (PCS)

  Through study completion, an average of 1 year

• Acceptance and Action Questionnaire - II

  Through study completion, an average of 1 year

Study Arms (3)

Experimental PBrE

EXPERIMENTAL

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

Control PBrE

PLACEBO COMPARATOR

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

Control

OTHER

Participants do not receive the intervention.

Behavioral: Control

Interventions

PBrE BEHAVIORAL

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.

Experimental PBrE

PBrE-Control BEHAVIORAL

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 PBrE

Control BEHAVIORAL

Participants do not receive the intervention.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Nacional de Educación a Distancia: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Miguel A. Vallejo

Madrid, 28040, Spain

Location

Related Publications (6)

• 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.

  PMID: 22317755 BACKGROUND

• 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.

  PMID: 25983704 BACKGROUND

• 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.

  PMID: 24447855 BACKGROUND

• 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.

  PMID: 23557844 BACKGROUND

• 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.

  PMID: 16314601 BACKGROUND

• 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.

  PMID: 23237331 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 10, 2019
• Study Start: October 7, 2019
• Primary Completion: May 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)