Fibromyalgia
Conditions
Keywords
Attentional bias modification, Dot-Probe Task, Fibromyalgia, ERPs, Pain-related Faces
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.
Interventions
BEHAVIORALABM
Direct attention away from pain-related information (i.e., facial expressions) through implicit training procedures
BEHAVIORALControl
Direct attention equally towards pain-related and neutral information (i.e., facial expressions) through implicit training procedures
Sponsors
Universidad Rey Juan Carlos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attentional bias from baseline (pre-training) | Behavioural 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. |
| Changes on Attentional bias from baseline (pre-training) to 1 day post-training | Behavioural attentional bias modification changes from baseline (pre-training vs 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
Countries
Spain
Outcome results
None listed