- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03466892
Repetitive Thinking in FibroMyalgia and Attentional Bias (PRFM-BA)
July 17, 2020 updated by: Centre Hospitalier Universitaire, Amiens
RTFM-AB - Repetitive Thinking in FibroMyalgia and Attentional Bias: Links Between Attentional Bias in Later Stages of Attention and Tendency to Repetitive Thinking
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Picardie
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Amiens, Picardie, France, 80054
- CHU Amiens Picardie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
One group.
It is a cross sectional study.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To measure attentional bias using a visual probe task paradigm.
Time Frame: 1 hour and 20 min
|
1 hour and 20 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2018
Primary Completion (Actual)
April 25, 2019
Study Completion (Actual)
April 25, 2019
Study Registration Dates
First Submitted
February 28, 2018
First Submitted That Met QC Criteria
March 14, 2018
First Posted (Actual)
March 15, 2018
Study Record Updates
Last Update Posted (Actual)
July 20, 2020
Last Update Submitted That Met QC Criteria
July 17, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2018_843_0003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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