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Repetitive Thinking in FibroMyalgia and Attentional Bias (PRFM-BA)

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ClinicalTrials.gov Identifier: NCT03466892
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
Theoretical models of chronic pain hypothesize a privileged treatment of pain-related information that would be the basis of avoidance behaviors in chronic pain. This privileged treatment, also called attentional bias, has been found experimentally in chronic pain. Meta-analyses confirmed that but leaded the question of the difference found between bias in period of attention orientation and bias in period of maintained attention. One of the hypotheses is to consider one or more cognitive processes that would "fix" the attention around significant perceived problems and that would hinder the attentional disengagement and the reorientation of attention towards neutral or positive stimuli. In view of the scientific literature in psychopathology but also in chronic pain we think that the negative repetitive thoughts (RNT) variable is one of these processes. So the investigators want to better understand the difference of attentional bias at different moments of the attentional process by interrogating the Repetitive Thinking variable. More specifically the investigators test the Attentional Bias hypothesis in Fibromyalgia. Patient with Fibromyalgia will be recruited at the Pain Center of CHU-Amiens. Patients will complete different scales and also the visual probe task. First, the investigators hypothesize the attention bias for pain-related information in the FM group is correlated with the level of negative repetitive thinking in the maintained attention phase. Second, the investigators hypothesize the attention bias is more important in the attention maintenance phase (1250 ms) than in the attention orientation phase (500 ms).

Condition or disease Intervention/treatment
Chronic Pain Other: Questionnaires and computer paradigm

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RTFM-AB - Repetitive Thinking in FibroMyalgia and Attentional Bias: Links Between Attentional Bias in Later Stages of Attention and Tendency to Repetitive Thinking
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : April 25, 2019
Estimated Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Questionnaires and computer paradigm
    Patients will complete different scales and also the visual probe task. First, we hypothesize the attention bias for pain-related information in the FM group is correlated with the level of negative repetitive thinking in the maintained attention phase. Second, we hypothesize the attention bias is more important in the attention maintenance phase (1250 ms) than in the attention orientation phase (500 ms).


Primary Outcome Measures :
  1. To measure attentional bias using a visual probe task paradigm. [ Time Frame: 1 hour and 20 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
One group. It is a cross sectional study.
Criteria

Inclusion Criteria:

Adults Patients inclusion criteria:

  • 1990 ACR Criteria of FM
  • Free and informed consent signed.
  • French mother tongue spoken, written, read.
  • Major person.

Exclusion Criteria:

  • Adult major under protection.
  • Patient with severe psychosis or depression or severe anxiety or impulsivity as -assessed by the clinician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466892


Contacts
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Contact: Eric SERRA, dOCTOR +333 22 66 88 20 serra.eric@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Eric SERRA, Dr    +33322668820    serra.eric@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03466892     History of Changes
Other Study ID Numbers: PI2018_843_0003
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Repetitive Negative Thinking
Rumination
Fibromyalgia
Chronic pain
Attentional Bias

Additional relevant MeSH terms:
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Chronic Pain
Fibromyalgia
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases