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Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia (PRFM-1)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibromyalgia focused on measuring Rumination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • FM Criteria of the American College of Rheumatology ACR 1990.
  • Major Patients
  • free and informed consent signed
  • stable treatment for at least one month
  • Native French speaker
  • Patient covered by health insurance.

Exclusion Criteria:

  • Patient deprived of liberty or protected major (under guardianship or curatorship)

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient with Fibromyalgia

Arm Description

Outcomes

Primary Outcome Measures

Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire
Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire

Secondary Outcome Measures

Full Information

First Posted
April 4, 2017
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03133455
Brief Title
Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia
Acronym
PRFM-1
Official Title
Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2015 (Actual)
Primary Completion Date
November 26, 2017 (Actual)
Study Completion Date
November 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

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

5. Study Description

Brief Summary
Dysfunctional chronic diffuse pain syndrome, concerning 2% of the French population, Fibromyalgia (FM) is classified either as a psychological disease or as a somatic disease. This dichotomous reasoning does not lead to a better understanding and does not allow the use or development of new psychological tools of care. The issue of the proximity between FM and depression highlighted by some authors and the presence of anxious comorbidities may arise at a different level, that of the transdiagnostic approach. Rumination is one of these transdiagnostic processes that are the subject of recent studies and one of the dimensions of which (abstract analytical rumination) is at work in depression and a number of psychopathologies. The investigator therefore wishes to explore the process of rumination and its abstract analytical dimension in FM and to explore its link with the depressive and anxious manifestations frequently associated with this disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Rumination

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with Fibromyalgia
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.
Intervention Description
Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.
Primary Outcome Measure Information:
Title
Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire
Description
Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: FM Criteria of the American College of Rheumatology ACR 1990. Major Patients free and informed consent signed stable treatment for at least one month Native French speaker Patient covered by health insurance. Exclusion Criteria: Patient deprived of liberty or protected major (under guardianship or curatorship)
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Learn more about this trial

Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia

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