Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05905159
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2023-05-30
Brief Title:
Attentional Bias Modification in Fibromyalgia Patients ABM
Sponsor:
Universidad Rey Juan Carlos
Organization:
Universidad Rey Juan Carlos
Study Overview
Official Title:
Neural Mechanisms Underlying Attentional Bias Modification in Fibromyalgia Patients a Double-blind ERP Study
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABM
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 questions 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
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 questions 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None