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Attentional Bias Modification in Fibromyalgia Patients (ABM) (ABM)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ABM
Control
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibromyalgia focused on measuring Attentional bias modification, Dot-Probe Task, Fibromyalgia, ERPs, Pain-related Faces

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ABM

Control

Arm 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).

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).

Outcomes

Primary Outcome Measures

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.
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
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.
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.

Secondary Outcome Measures

Anxiety scores from baseline (pre-training) to 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.
Depression scores from baseline (pre-training) to 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.
Fear of pain scores from baseline (pre-training) to 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 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.
Fibromyalgia impact scores from baseline (pre-training) to 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.
Pain scores from baseline (pre-training) to 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 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.

Full Information

First Posted
May 30, 2023
Last Updated
June 14, 2023
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT05905159
Brief Title
Attentional Bias Modification in Fibromyalgia Patients (ABM)
Acronym
ABM
Official Title
Neural Mechanisms Underlying Attentional Bias Modification in Fibromyalgia Patients: a Double-blind ERP Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
March 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Attentional bias modification, Dot-Probe Task, Fibromyalgia, ERPs, Pain-related Faces

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABM
Arm Type
Experimental
Arm 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).
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
ABM
Intervention Description
Direct attention away from pain-related information (i.e., facial expressions) through implicit training procedures
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Direct attention equally towards pain-related and neutral information (i.e., facial expressions) through implicit training procedures
Primary Outcome Measure Information:
Title
Attentional bias from baseline (pre-training)
Description
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.
Time Frame
Behavioural Attentional bias from baseline (pre-training)
Title
Attentional bias from baseline (pre-training)
Description
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.
Time Frame
ERPs Attentional bias from baseline (pre-training)
Title
Changes on Attentional bias from baseline (pre-training) to 1 day post-training
Description
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.
Time Frame
Behavioural attentional bias modification changes from baseline (pre-training vs 1 day post-training)
Title
Changes on Attentional bias from baseline (pre-training) to 1 day post-training
Description
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.
Time Frame
ERPs attentional bias modification changes from baseline (pre-training vs 1 day post-training)
Secondary Outcome Measure Information:
Title
Anxiety scores from baseline (pre-training) to 1 day post-training
Description
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.
Time Frame
Anxiety scores from baseline changes from baseline (pre-training vs 1 day post-training)
Title
Depression scores from baseline (pre-training) to 1 day post-training
Description
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.
Time Frame
Depression scores from baseline changes from baseline (pre-training vs 1 day post-training)
Title
Fear of pain scores from baseline (pre-training) to 1 day post-training
Description
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.
Time Frame
Fear of pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
Title
Pain worrying scores from baseline (pre-training) to 1 day post-training
Description
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.
Time Frame
Pain worrying scores from baseline changes from baseline (pre-training vs 1 day post-training)
Title
Fibromyalgia impact scores from baseline (pre-training) to 1 day post-training
Description
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.
Time Frame
Fibromyalgia impact scores from baseline changes from baseline (pre-training vs 1 day post-training)
Title
Pain scores from baseline (pre-training) to 1 day post-training
Description
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.
Time Frame
Pain scores from baseline changes from baseline (pre-training vs 1 day post-training)
Title
Fatigue scores from baseline (pre-training) to 1 day post-training
Description
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.
Time Frame
Fatigue scores from baseline changes from baseline (pre-training vs 1 day post-training)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Mercado, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28047
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33682161
Citation
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.
Results Reference
background
PubMed Identifier
19627649
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.
Results Reference
background
PubMed Identifier
31693540
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.
Results Reference
background
PubMed Identifier
23333054
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.
Results Reference
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PubMed Identifier
34995568
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.
Results Reference
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PubMed Identifier
24652823
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.
Results Reference
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PubMed Identifier
26291997
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.
Results Reference
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Attentional Bias Modification in Fibromyalgia Patients (ABM)

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