Neural Mechanisms Underlying Attentional Bias Modification in Fibromyalgia Patients: a Double-blind ERP Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Universidad Rey Juan Carlos
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Attentional bias from baseline (pre-training)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Josue Fernandez Carnero
Professor
Universidad Rey Juan Carlos
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
Outcomes
Primary Outcomes
Attentional bias from baseline (pre-training)
Time Frame: ERPs 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.
Changes on Attentional bias from baseline (pre-training) to 1 day post-training
Time Frame: ERPs attentional bias modification changes from baseline (pre-training vs 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.
Secondary Outcomes
- 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))
- 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))
- 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))
- Pain scores from baseline (pre-training) to 1 day post-training(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 scores from baseline changes from baseline (pre-training vs 1 day post-training))