NCT03133455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2017

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

April 4, 2017

Last Update Submit

September 16, 2025

Conditions

Keywords

Rumination

Outcome Measures

Primary Outcomes (1)

  • 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

    1 hour

Study Arms (1)

Patient with Fibromyalgia

OTHER
Other: Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.

Interventions

Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.

Patient with Fibromyalgia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Related Publications (1)

  • Fonseca Das Neves J, Serra E, Kosinski T, Marechal V, Rollin N, Richard O, Jehel L, Rusinek S. Catastrophizing and rumination mediate the link between functional disabilities and anxiety/depression in fibromyalgia. A double-mediation model. Encephale. 2024 Apr;50(2):162-169. doi: 10.1016/j.encep.2023.04.004. Epub 2023 May 1.

MeSH Terms

Conditions

FibromyalgiaRumination Syndrome

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 28, 2017

Study Start

September 16, 2015

Primary Completion

November 26, 2017

Study Completion

November 26, 2017

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations