FibromyalgiaPRFM-1NCT03133455
Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia
A study testing Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM. in people with Fibromyalgia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2015to 26 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient deprived of liberty or protected major (under guardianship or curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.
- Keywords
- Rumination
- Medical subject headings
- Fibromyalgia, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.Other
Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Fibromyalgia | Other | Not described Receives: Other: Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start16 Sep 2015
- Primary completion26 Nov 2017
- Study completion26 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133455
- Sponsor's protocol ID
- PI2015_843_0024
- Acronym
- PRFM-1
- Status last verified
- Sep 2025
- First submitted
- 4 Apr 2017
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37137739
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia
- ClinicalTrials.gov ID
- NCT03133455
- Acronym / sponsor ID
- PRFM-1 / PI2015_843_0024
- Conditions
- Fibromyalgia
- Keywords
- Rumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 26 Nov 2017 (actual)
- Study completion
- 26 Nov 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Fibromyalgia | Other | Other: Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patient deprived of liberty or protected major (under guardianship or curatorship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM. | Other | Patient with Fibromyalgia |
Primary outcome
Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire
Time frame: 1 hour
Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 37137739Fonseca 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM. in people with Fibromyalgia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.