Attentional Bias Modification in Fibromyalgia Patients (ABM) (ABM)

Neural Mechanisms Underlying Attentional Bias Modification in Fibromyalgia Patients: a Double-blind ERP Study

There is a growing interest in the potential benefits of attentional bias modification (ABM) training in chronic pain patients. However, studies examining the effectiveness of ABM programs in fibromyalgia patients have demonstrated inconclusive effects on both behavioral indices and clinical symptoms. Underlying neural dynamics of ABM effects could yield additional insights but remain yet unexplored.

Current study, therefore, aimed investigating the effects of ABM training on known neural indicators of attentional bias to pain using electroencephalography (EEG).

The goal of this clinical trial is to test the effects of ABM training on known neural indicators of attentional bias to pain using electroencephalography (EEG) in fibromyalgia patients

The main question[s] it aims to answer are:

• Are fibromyalgia patients sensitive to ABM procedures?
• What are the neural indices associated with ABM procedures?
• Do ABM procedures transfer of effects on the clinical symptomatology in fibromyalgia patients?

Participants will performes five sessions consisting of a modified dot-probe task in which patients were trained to avoid facial pain expressions, whereas in the control group participants will performes five sessions consisting of a standard dot-probe task. Potential ABM training effects will be evaluated by comparing a single pre- and post-treatment session, in which event-related potentials (ERPs) will be recorded in response to three experimental tasks (standard dot-probe, RIR, and visual tasks).

Furthermore, patients will fill a series of self-report questionnaires assessing anxiety, depression, pain-related worrying, fear of pain, fatigue and pain status.

Researchers will compare two fibromyalgia patients groups that will enrolled and randomly assigned to an ABM training in order to see attentional improvements in the training fibromyalgia group.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: ABM; Behavioral: Control

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28047
      • Universidad Rey Juan Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Fibromyalgia Diagnosis.
• Female sex
• The presence of clinical symptoms regarding anxiety or depression will be not exclusion criteria, as long as fibromyalgia was participants' primary diagnosis.

Exclusion Criteria:

• Participation in the study will require the absence of neurological and psychiatric disorders that impair cognitive functions (i.e., stroke brain damage, psychosis, bipolar disorder, and substance abuse/dependence).
• Pregnancy
• Not being able to read Spanish in order to fill in the questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABM; ABM training will consist of five sessions over five consecutive days during which patients performed a modified version of the visual dot-probe task. The whole ABM program will include a total of 1000 trials that will be distributed in 200 trials per session (twenty minutes per session). Participants assigned to ABM training condition will be trained implicitly to attend away from pain-related stimuli (i.e., facial expressions). They will be presented with a modified dot-probe task with trials including targets that often replaced neutral faces. Thus, 80% of trials (i.e., 160 trials) included targets that replaced neutral cue faces (pain incongruent trials: target appeared in the opposite side of pain-related faces). The rest of trials (i.e., 40 trials) belonged to pain congruent trials (i.e., target will occur in the same location of the pain-related facial expression).	Behavioral: ABM; Direct attention away from pain-related information (i.e., facial expressions) through implicit training procedures
Placebo Comparator: Control; By contrast, patients assigned to control condition were exposed to a standard visual dot-probe task in which targets were equally likely to replace pain or neutral cues (i.e., facial expressions) during pain trials (i.e., 50% pain-incongruent trials and 50% pain-congruent tri-als). The whole Control program will include a total of 1000 trials that will be distributed in 200 trials per session (twenty minutes per session).	Behavioral: Control; Direct attention equally towards pain-related and neutral information (i.e., facial expressions) through implicit training procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional bias from baseline (pre-training)	Attentional bias will be assessed by dot-probe task. Behavioural reaction times outcomes will be recorder. The reaction time average for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.	Behavioural Attentional bias from baseline (pre-training)
Attentional bias from baseline (pre-training)	Attentional bias will be assessed by dot-probe task. Event-related potentials (ERPs) outcomes will be recorder. The P2 and N2 ERPs average amplitudes for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.	ERPs Attentional bias from baseline (pre-training)
Changes on Attentional bias from baseline (pre-training) to 1 day post-training	Attentional bias will be assessed by dot-probe task. Behavioural reaction times outcomes will be recorder. To test the effect of the ABM procedure, the reaction time average for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.	Behavioural attentional bias modification changes from baseline (pre-training vs 1 day post-training)
Changes on Attentional bias from baseline (pre-training) to 1 day post-training	Attentional bias will be assessed by dot-probe task. ERPs outcomes will be recorder. To test the effect of the ABM procedure, ERPs amplitudes for each dot-probe condition will be included as intrasubject factor and the training group as between-subject factor.	ERPs attentional bias modification changes from baseline (pre-training vs 1 day post-training)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety scores from baseline (pre-training) to 1 day post-training	Anxiety will be assessed by the Spanish version of the State-Trait Anxiety Inventory (STAI) questionnaire. The scale include 20 items and are scored using a four-point Likert scale, ranging from 0 to 3. Higher scores (i.e., > 60 percentile) represents high anxiety levels. Anxiety scores will be included as intrasubject factor and the training group as between-subject factor.	Anxiety scores from baseline changes from baseline (pre-training vs 1 day post-training)
Depression scores from baseline (pre-training) to 1 day post-training	Depression will be assessed by the Spanish version of the Beck Depression Inventory (BDI). The scale include 21 items with four different statements describing various degrees of symptom intensity. Higher scores (i.e., > 21) represents greater severity of depressive symptoms. Depression scores will be included as intrasubject factor and the training group as between-subject factor.	Depression scores from baseline changes from baseline (pre-training vs 1 day post-training)
Fear of pain scores from baseline (pre-training) to 1 day post-training	Fear of pain will be assessed by the Spanish version of Fear of Pain Questionnaire (FPQ). In FPQ questionnaire participants are asked to rate in 30 items how fearful to pain experiences on a 5-point Likert scale. Higher scores represents greater severity of fear of pain symptoms. Fear of pain scores will be included as intrasubject factor and the training group as between-subject factor.	Fear of pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
Pain worrying scores from baseline (pre-training) to 1 day post-training	Pain worrying will be assessed by the Spanish versions of the Pain Catastrophizing Scale (PCS). In this scale, participants rated in 13 items the frequency of experiencing each catastrophic belief on a 0 to 4 Likert scale. Higher scores represents greater severity of pain worrying symptoms. Pain worrying scores will be included as intrasubject factor and the training group as between-subject factor.	Pain worrying scores from baseline changes from baseline (pre-training vs 1 day post-training)
Fibromyalgia impact scores from baseline (pre-training) to 1 day post-training	Fibromyalgia impact will be assessed by the Spanish version of the Fibromyalgia Impact Questionnaire (FIQ). FIQ consists of 10 items for the assessment of three fibromyalgia domains (function, overall impact and symptoms). Higher scores represents greater severity of fibromyalgia impact symptoms. Fibromyalgia impact scores will be included as intrasubject factor and the training group as between-subject factor.	Fibromyalgia impact scores from baseline changes from baseline (pre-training vs 1 day post-training)
Pain scores from baseline (pre-training) to 1 day post-training	Pain status will be assessed by a visual analogue scale (VAS). The scale include 0 to 10 likert scale. Higher scores (i.e., > 6) represents greater severity of pain intensity symptoms. Pain scores will be included as intrasubject factor and the training group as between-subject factor.	Pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
Fatigue scores from baseline (pre-training) to 1 day post-training	Fatigue status will be assessed by a visual analogue scale (VAS). The scale include 0 to 10 likert scale. Higher scores (i.e., > 6) represents greater severity of fatigue intensity symptoms. Fatigue scores will be included as intrasubject factor and the training group as between-subject factor.	Fatigue scores from baseline changes from baseline (pre-training vs 1 day post-training)

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: Francisco Mercado, PhD, Universidad Rey Juan Carlos

Publications and helpful links

General Publications

• Mogoase C, David D, Koster EH. Clinical efficacy of attentional bias modification procedures: an updated meta-analysis. J Clin Psychol. 2014 Dec;70(12):1133-57. doi: 10.1002/jclp.22081. Epub 2014 Mar 20.
• Carlson JM. A systematic review of event-related potentials as outcome measures of attention bias modification. Psychophysiology. 2021 Jun;58(6):e13801. doi: 10.1111/psyp.13801. Epub 2021 Mar 8.
• Eldar S, Bar-Haim Y. Neural plasticity in response to attention training in anxiety. Psychol Med. 2010 Apr;40(4):667-77. doi: 10.1017/S0033291709990766. Epub 2009 Jul 23.
• Carleton RN, Asmundson GJG, Korol SL, LeBouthillier DM, Hozempa K, Katz JD, Vlaeyen JWS, Crombez G. Evaluating the efficacy of an attention modification program for patients with fibromyalgia: a randomized controlled trial. Pain. 2020 Mar;161(3):584-594. doi: 10.1097/j.pain.0000000000001746.
• Crombez G, Van Ryckeghem DML, Eccleston C, Van Damme S. Attentional bias to pain-related information: a meta-analysis. Pain. 2013 Apr;154(4):497-510. doi: 10.1016/j.pain.2012.11.013. Epub 2012 Dec 5.
• Fernandes-Magalhaes R, Ferrera D, Pelaez I, Martin-Buro MC, Carpio A, De Lahoz ME, Barjola P, Mercado F. Neural correlates of the attentional bias towards pain-related faces in fibromyalgia patients: An ERP study using a dot-probe task. Neuropsychologia. 2022 Feb 10;166:108141. doi: 10.1016/j.neuropsychologia.2021.108141. Epub 2022 Jan 4.
• Todd J, Sharpe L, Johnson A, Nicholson Perry K, Colagiuri B, Dear BF. Towards a new model of attentional biases in the development, maintenance, and management of pain. Pain. 2015 Sep;156(9):1589-1600. doi: 10.1097/j.pain.0000000000000214.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): March 12, 2023

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Fibromyalgia; ERPs; Dot-Probe Task; Attentional bias modification; Pain-related Faces
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: ABM-URJC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No