Attentional Bias Modification in Fibromyalgia Patients (ABM)

Universidad Rey Juan Carlos

Status: Completed

Conditions: Fibromyalgia

Treatments: Behavioral: Control; Behavioral: ABM

Study type: Interventional

Funder types: Other

Identifiers

NCT05905159

ABM-URJC

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

ABM

Experimental group

Description:

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).

Treatment:

Behavioral: ABM

Control

Placebo Comparator group

Description:

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).

Treatment:

Behavioral: Control