Clinical trial NCT05905159: Attentional Bias Modification in Fibromyalgia Patients (ABM)
Official title: Neural Mechanisms Underlying Attentional Bias Modification in Fibromyalgia Patients: a Double-blind ERP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Attentional bias modification
Dot-Probe Task
Fibromyalgia
ERPs
Pain-related Faces
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Attentional bias from baseline (pre-training)
timeFrame: Behavioural Attentional bias from baseline (pre-training)
measure: Attentional bias from baseline (pre-training)
timeFrame: ERPs Attentional bias from baseline (pre-training)
measure: Changes on Attentional bias from baseline (pre-training) to 1 day post-training
timeFrame: Behavioural attentional bias modification changes from baseline (pre-training vs 1 day post-training)
measure: Changes on Attentional bias from baseline (pre-training) to 1 day post-training
timeFrame: ERPs attentional bias modification changes from baseline (pre-training vs 1 day post-training)
Secondary outcomes:
measure: Anxiety scores from baseline (pre-training) to 1 day post-training
timeFrame: Anxiety scores from baseline changes from baseline (pre-training vs 1 day post-training)
measure: Depression scores from baseline (pre-training) to 1 day post-training
timeFrame: Depression scores from baseline changes from baseline (pre-training vs 1 day post-training)
measure: Fear of pain scores from baseline (pre-training) to 1 day post-training
timeFrame: Fear of pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
measure: Pain worrying scores from baseline (pre-training) to 1 day post-training
timeFrame: Pain worrying scores from baseline changes from baseline (pre-training vs 1 day post-training)
measure: Fibromyalgia impact scores from baseline (pre-training) to 1 day post-training
timeFrame: Fibromyalgia impact scores from baseline changes from baseline (pre-training vs 1 day post-training)
measure: Pain scores from baseline (pre-training) to 1 day post-training
timeFrame: Pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
measure: Fatigue scores from baseline (pre-training) to 1 day post-training
timeFrame: Fatigue scores from baseline changes from baseline (pre-training vs 1 day post-training)
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Francisco Mercado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.