Attentional Bias Modification in Fibromyalgia Patients (ABM)

NCT05905159 | Completed

• 1 other identifier: ABM-URJC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Attentional bias modification; Dot-Probe Task; Fibromyalgia; ERPs; Pain-related Faces

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Anxiety scores from baseline (pre-training) to 1 day post-training

  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 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 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 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 scores from baseline changes from baseline (pre-training vs 1 day post-training)

Study Arms (2)

ABM

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

ABM BEHAVIORAL

Direct attention away from pain-related information (i.e., facial expressions) through implicit training procedures

ABM

Control BEHAVIORAL

Direct attention equally towards pain-related and neutral information (i.e., facial expressions) through implicit training procedures

Control

Eligibility Criteria

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

You may qualify if:

• Fibromyalgia Diagnosis.
• Female sex

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28047, Spain

Location

Related Publications (8)

• 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.

  PMID: 33682161 BACKGROUND

• 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.

  PMID: 19627649 BACKGROUND

• 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.

  PMID: 31693540 BACKGROUND

• 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.

  PMID: 23333054 BACKGROUND

• 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.

  PMID: 34995568 BACKGROUND

• 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.

  PMID: 24652823 BACKGROUND

• 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.

  PMID: 26291997 BACKGROUND

• Fernandes-Magalhaes R, Carpio A, Ferrera D, Pelaez I, De Lahoz ME, Van Ryckeghem D, Van Damme S, Mercado F. Neural mechanisms underlying attentional bias modification in fibromyalgia patients: a double-blind ERP study. Eur Arch Psychiatry Clin Neurosci. 2024 Aug;274(5):1197-1213. doi: 10.1007/s00406-023-01709-4. Epub 2023 Nov 19.

  PMID: 37980687 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Francisco Mercado, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 15, 2023
• Study Start: January 12, 2023
• Primary Completion: February 23, 2023
• Study Completion: March 12, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)