Somatic SymptomsPSOMANCT06582173
Mapping the Healthcare Pathway to Multidisciplinary Assessment of 12-25 Year Olds With Somatic Symptom Disorder
An observational study of Somatic Symptoms and Medically Unexplained Symptoms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to describe the course of successive care events that follow individuals with somatic symptom disorder until they are assessed by a specialized multidisciplinary team. Data is collected during interviews with subjects aged 12 to 25 years old accompanied by their parents. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Somatic Symptoms, Medically Unexplained Symptoms, Somatoform Disorders
- What is being tested?
- Face-to-face interviews assisted by a biographical grid
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants are selected among patients assessed in the recruiting centre, whatever their course after assessment. The recruiting centre is an adolescent clinic which is part of a public teaching hospital in Paris, France. The centre provides inpatient and outpatient care delivered by a multidisciplinary team. Patients aged 11 to 18 can be referred to this centre by a healthcare professional or can directly access to care, regardless of their living area. For each patient included, parents are asked to participate to research interviews to help map the healthcare pathway their child followed.
Who may be able to join
- Criteria relating to the population studied:
- Age between 12 and 25 years old
- Diagnosis of somatic symptom disorder and derivatives (DSM 5) after specialized multidisciplinary evaluation by the team of the Maison des Adolescents of Cochin hospital (Maison de Solenn).
- Criteria relating to the additional population participating in the research:
- Being a parent of a subject who has received the diagnosis of somatic symptom disorder and derivatives (DSM 5) after specialized multidisciplinary evaluation at the Maison des Adolescents of Cochin Hospital (Maison de Solenn).
Who cannot join
- Criteria relating to the population studied:
- Age less than 12 years or greater than 25 years at the time of assessment,
- Subject presenting ongoing psychiatric decompensation, that is to say a state of mental health breaking with their baseline state and requiring rapid care which does not allow a research interview to be carried out.
- Criteria relating to the additional population participating in the research:
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Maison de Solenn Maison des Adolescents, Cochin Hospital
Paris, IDF, 75014
Maude LUDOT-GREGOIRE, MD, PhD, +33 1 58 41 24 26, maude.ludot@aphp.fr
Maude LUDOT-GREGOIRE, MD
About this study
Official title: Mapping the Healthcare Pathway to Specialised Multidisciplinary Assessment of 12-25 Year Olds With Somatic Symptom Disorder: a Monocentric Descriptive Study Based on Interviews Assisted by a Biographical Grid
This study aims to describe the course of successive care events that follow individuals with somatic symptom disorder until they are assessed by a specialized multidisciplinary team. Data is collected during interviews with subjects aged 12 to 25 years old accompanied by their parents. A biographical grid is used to retrospectively identify all care events that occurred from first symptoms until multidisciplinary assessment. Life events and symptoms are collected as well to explore how history of healthcare consumption is linked to other trajectories. A qualitative analysis of the recorded interviews aims to describe the subjective experience of this healthcare pathway.
Read the detailed description
Somatic symptom disorders (SSD), previously labelled Somatoform disorders, are known to challenge healthcare professionals and systems, as those common conditions reducing quality of life often lead to excessive referrals and investigations before adequate diagnosis and management. Although studies have proved multiple interventions to be effective and cost-effective in various clinical settings, little is known about the accurate healthcare utilization associated with SSD. Such analysis faces the complexity of SSD detection and labelling due to heterogeneous clinical presentations and disputed cross-disciplinary classifications. Even though healthcare is known to be a core theme of patient experience of SSD, the investigators lack data describing the trajectory of care and the expectations, perceived help and triggering events associated with healthcare services use. A better understanding of the healthcare pathway those patients follow will help implement evidence-based treatment effectively.
The aim of this study is to trace back the pathway of care that individuals follow before they eventually undergo a specialised multidisciplinary assessment.
This descriptive study relies on data retrospectively collected from patients and their parents during face-to-face interviews assisted by a biographical grid. Inclusion criteria for patients are to be aged 12 to 25 years old and to be diagnosed with SSD by a specialised multidisciplinary team. Variables measured to describe the healthcare pathway are chosen according to professional experience and literature review. They are collected alongside concomitant life events both to reduce memory bias and to explore determinants and effects of healthcare consumption as a secondary outcome. The subjective experience of this healthcare pathway described by patients and their parents is analysed qualitatively in the verbatim of the audio recorded interview.
- Being tested
- Face-to-face interviews assisted by a biographical grid
- Keywords
- Somatic symptoms, Somatoform disorder, Medically unexplained symptoms, Healthcare pathway, Healthcare trajectory, Care episodes, Health Care Utilization, Adolescent, Young Adult
- Medical subject headings
- Medically Unexplained Symptoms, Somatoform Disorders, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face interviews assisted by a biographical gridOther
Face-to-face interviews assisted by a biographical grid.
Healthcare event of the adolescent :
- medical specialist appointment
- general practitioner appointment
- emergency services use
- hospital admission
- diagnostic test
- medication use
- non-pharmacological treatment
- nursing or physical therapy
- alternative care
Biographical of the adolescent :
- Education event
- Class/level
- School
- Attendance
- Special arrangements
- Grades
- Off school education
- Family event
- Separation/union
- Birth/death
- Leave/Arrival
- Location/Moving
- Disease/accident
- Peer events
- Friendships
- Love interests
- Bullying
- Leisure \& interests events
- Activity
- Frequency
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Patients aged 12 to 25 years old and diagnosed with SSD by a specialised multidisciplinary team Receives: Other: Face-to-face interviews assisted by a biographical grid | |
| Parents | Parents of an adolescent included Receives: Other: Face-to-face interviews assisted by a biographical grid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of healthcare events
Successive healthcare events of individuals with somatic symptom disorder, from first symptoms to specialised multidisciplinary assessment
Measured: Day of inclusion
Secondary outcomes (7)
Raise of healthcare events occurrence
Raise of healthcare events occurrence following the occurrence of somatic symptoms.
From first symptoms to specialised multidisciplinary assessment
Measured: Day of inclusion
Raise of life events occurrence
From first symptoms to specialised multidisciplinary assessment
Measured: Day of inclusion
Decrease of healthcare events occurrence
Decrease of healthcare events occurrence following the occurrence of somatic symptoms.
From first symptoms to specialised multidisciplinary assessment
Measured: Day of inclusion
Decrease of life events occurrence
From first symptoms to specialised multidisciplinary assessment
Measured: Day of inclusion
Modification of somatic symptoms occurrence
From first symptoms to specialised multidisciplinary assessment
Measured: Day of inclusion
Modification of life events occurrence
Modification of life events occurrence following healthcare. From first symptoms to specialised multidisciplinary assessment
Measured: Day of inclusion
Qualitative analysis of the transcribed interviews
Identification of themes emerging from the qualitative analysis of the transcribed interviews
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start10 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Somatic SymptomsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Maude LUDOT-GREGOIRE, MD, PhD, Principal investigator, Maison des Adolescents - Cochin Hospital - AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582173
- Sponsor's protocol ID
- APHP240890
- Other IDs
- 2024-A01371-46
- Acronym
- PSOMA
- Status last verified
- Jun 2026
- First submitted
- 30 Aug 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Joustra ML, Janssens KA, Bultmann U, Rosmalen JG. Functional limitations in functional somatic syndromes and well-defined medical diseases. Results from the general population cohort LifeLines. J Psychosom Res. 2015 Aug;79(2):94-9. doi: 10.1016/j.jpsychores.2015.05.004. Epub 2015 May 16.
PubMed 26026696van Dessel N, den Boeft M, van der Wouden JC, Kleinstauber M, Leone SS, Terluin B, Numans ME, van der Horst HE, van Marwijk H. Non-pharmacological interventions for somatoform disorders and medically unexplained physical symptoms (MUPS) in adults. Cochrane Database Syst Rev. 2014 Nov 1;2014(11):CD011142. doi: 10.1002/14651858.CD011142.pub2.
PubMed 25362239Wortman MSH, Lokkerbol J, van der Wouden JC, Visser B, van der Horst HE, Olde Hartman TC. Cost-effectiveness of interventions for medically unexplained symptoms: A systematic review. PLoS One. 2018 Oct 15;13(10):e0205278. doi: 10.1371/journal.pone.0205278. eCollection 2018.
PubMed 30321193Gosselin A, Desgrees du Lou A, Lelievre E; PARCOURS Study Group. How to use sequence analysis for life course epidemiology? An example on HIV-positive Sub-Saharan migrants in France. J Epidemiol Community Health. 2018 Jun;72(6):507-512. doi: 10.1136/jech-2017-209739. Epub 2018 Feb 2.
PubMed 29437866Sawyer SM, Azzopardi PS, Wickremarathne D, Patton GC. The age of adolescence. Lancet Child Adolesc Health. 2018 Mar;2(3):223-228. doi: 10.1016/S2352-4642(18)30022-1. Epub 2018 Jan 30.
PubMed 30169257Kachaner A, Harim M, Combier A, Trouvin AP, Avouac J, Ranque B, Piot MA. Management perspectives from patients with fibromyalgia experiences with the healthcare pathway: a qualitative study. Front Med (Lausanne). 2023 Dec 1;10:1231951. doi: 10.3389/fmed.2023.1231951. eCollection 2023.
PubMed 38105901Hinton D, Kirk S. Families' and healthcare professionals' perceptions of healthcare services for children and young people with medically unexplained symptoms: a narrative review of the literature. Health Soc Care Community. 2016 Jan;24(1):12-26. doi: 10.1111/hsc.12184. Epub 2015 Feb 16.
PubMed 25684117Ludot M, Merlo M, Ibrahim N, Piot MA, Lefevre H, Carles ME, Harf A, Moro MR. ["Somatic symptom disorders" in adolescence. A systematic review of the recent literature]. Encephale. 2021 Dec;47(6):596-604. doi: 10.1016/j.encep.2021.04.007. Epub 2021 Sep 16. French.
PubMed 34538623
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Healthcare Pathway to Specialised Multidisciplinary Assessment of 12-25 Year Olds With Somatic Symptom Disorder: a Monocentric Descriptive Study Based on Interviews Assisted by a Biographical Grid
- ClinicalTrials.gov ID
- NCT06582173
- Acronym / sponsor ID
- PSOMA / APHP240890
- Keywords
- Somatic symptoms, Somatoform disorder, Medically unexplained symptoms, Healthcare pathway, Healthcare trajectory, Care episodes, Health Care Utilization, Adolescent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Sep 2024 (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.
This study aims to describe the course of successive care events that follow individuals with somatic symptom disorder until they are assessed by a specialized multidisciplinary team. Data is collected during interviews with subjects aged 12 to 25 years old accompanied by their parents. A biographical grid is used to retrospectively identify all care events that occurred from first symptoms until multidisciplinary assessment. Life events and symptoms are collected as well to explore how history of healthcare consumption is linked to other trajectories. A qualitative analysis of the recorded interviews aims to describe the subjective experience of this healthcare pathway.
Detailed description
Somatic symptom disorders (SSD), previously labelled Somatoform disorders, are known to challenge healthcare professionals and systems, as those common conditions reducing quality of life often lead to excessive referrals and investigations before adequate diagnosis and management. Although studies have proved multiple interventions to be effective and cost-effective in various clinical settings, little is known about the accurate healthcare utilization associated with SSD. Such analysis faces the complexity of SSD detection and labelling due to heterogeneous clinical presentations and disputed cross-disciplinary classifications. Even though healthcare is known to be a core theme of patient experience of SSD, the investigators lack data describing the trajectory of care and the expectations, perceived help and triggering events associated with healthcare services use. A better understanding of the healthcare pathway those patients follow will help implement evidence-based treatment effectively.
The aim of this study is to trace back the pathway of care that individuals follow before they eventually undergo a specialised multidisciplinary assessment.
This descriptive study relies on data retrospectively collected from patients and their parents during face-to-face interviews assisted by a biographical grid. Inclusion criteria for patients are to be aged 12 to 25 years old and to be diagnosed with SSD by a specialised multidisciplinary team. Variables measured to describe the healthcare pathway are chosen according to professional experience and literature review. They are collected alongside concomitant life events both to reduce memory bias and to explore determinants and effects of healthcare consumption as a secondary outcome. The subjective experience of this healthcare pathway described by patients and their parents is analysed qualitatively in the verbatim of the audio recorded interview.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | Other: Face-to-face interviews assisted by a biographical gridPatients aged 12 to 25 years old and diagnosed with SSD by a specialised multidisciplinary team |
| Parents | – | Other: Face-to-face interviews assisted by a biographical gridParents of an adolescent included |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are selected among patients assessed in the recruiting centre, whatever their course after assessment. The recruiting centre is an adolescent clinic which is part of a public teaching hospital in Paris, France. The centre provides inpatient and outpatient care delivered by a multidisciplinary team. Patients aged 11 to 18 can be referred to this centre by a healthcare professional or can directly access to care, regardless of their living area. For each patient included, parents are asked to participate to research interviews to help map the healthcare pathway their child followed.
Key inclusion criteria (5 listed)
- Age between 12 and 25 years old
- Diagnosis of somatic symptom disorder and derivatives (DSM 5) after specialized multidisciplinary evaluation by the team of the Maison des Adolescents of Cochin hospital (Maison de Solenn).
- Being a parent of a subject who has received the diagnosis of somatic symptom disorder and derivatives (DSM 5) after specialized multidisciplinary evaluation at the Maison des Adolescents of Cochin Hospital (Maison de Solenn).
Key exclusion criteria (5 listed)
- Age less than 12 years or greater than 25 years at the time of assessment,
- Subject presenting ongoing psychiatric decompensation, that is to say a state of mental health breaking with their baseline state and requiring rapid care which does not allow a research interview to be carried out.
- None
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 |
|---|---|---|
| Face-to-face interviews assisted by a biographical gridFace-to-face interviews assisted by a biographical grid. Healthcare event of the adolescent : * medical specialist appointment * general practitioner appointment * emergency services use * hospital admission * diagnostic test * medication use * non-pharmacological treatment * nursing or physical therapy * alternative care Biographical of the adolescent : * Education event * Class/level * School * Attendance * Special arrangements * Grades * Off school education * Family event * Separation/union * Birth/death * Leave/Arrival * Location/Moving * Disease/accident * Peer events * Friendships * Love interests * Bullying * Leisure \& interests events * Activity * Frequency | Other | Adolescents, Parents |
Primary outcome
Occurrence of healthcare events
Time frame: Day of inclusion
Successive healthcare events of individuals with somatic symptom disorder, from first symptoms to specialised multidisciplinary assessment
7 secondary outcomes
Raise of healthcare events occurrence
Time frame: Day of inclusion
Raise of life events occurrence
Time frame: Day of inclusion
Decrease of healthcare events occurrence
Time frame: Day of inclusion
Decrease of life events occurrence
Time frame: Day of inclusion
Modification of somatic symptoms occurrence
Time frame: Day of inclusion
Modification of life events occurrence
Time frame: Day of inclusion
Qualitative analysis of the transcribed interviews
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 26026696Joustra ML, Janssens KA, Bultmann U, Rosmalen JG. Functional limitations in functional somatic syndromes and well-defined medical diseases. Results from the general population cohort LifeLines. J Psychosom Res. 2015 Aug;79(2):94-9. doi: 10.1016/j.jpsychores.2015.05.004. Epub 2015 May 16.
- Background: PubMed 25362239van Dessel N, den Boeft M, van der Wouden JC, Kleinstauber M, Leone SS, Terluin B, Numans ME, van der Horst HE, van Marwijk H. Non-pharmacological interventions for somatoform disorders and medically unexplained physical symptoms (MUPS) in adults. Cochrane Database Syst Rev. 2014 Nov 1;2014(11):CD011142. doi: 10.1002/14651858.CD011142.pub2.
- Background: PubMed 30321193Wortman MSH, Lokkerbol J, van der Wouden JC, Visser B, van der Horst HE, Olde Hartman TC. Cost-effectiveness of interventions for medically unexplained symptoms: A systematic review. PLoS One. 2018 Oct 15;13(10):e0205278. doi: 10.1371/journal.pone.0205278. eCollection 2018.
- Background: PubMed 29437866Gosselin A, Desgrees du Lou A, Lelievre E; PARCOURS Study Group. How to use sequence analysis for life course epidemiology? An example on HIV-positive Sub-Saharan migrants in France. J Epidemiol Community Health. 2018 Jun;72(6):507-512. doi: 10.1136/jech-2017-209739. Epub 2018 Feb 2.
- Background: PubMed 30169257Sawyer SM, Azzopardi PS, Wickremarathne D, Patton GC. The age of adolescence. Lancet Child Adolesc Health. 2018 Mar;2(3):223-228. doi: 10.1016/S2352-4642(18)30022-1. Epub 2018 Jan 30.
- Background: PubMed 38105901Kachaner A, Harim M, Combier A, Trouvin AP, Avouac J, Ranque B, Piot MA. Management perspectives from patients with fibromyalgia experiences with the healthcare pathway: a qualitative study. Front Med (Lausanne). 2023 Dec 1;10:1231951. doi: 10.3389/fmed.2023.1231951. eCollection 2023.
- Background: PubMed 25684117Hinton D, Kirk S. Families' and healthcare professionals' perceptions of healthcare services for children and young people with medically unexplained symptoms: a narrative review of the literature. Health Soc Care Community. 2016 Jan;24(1):12-26. doi: 10.1111/hsc.12184. Epub 2015 Feb 16.
- Background: PubMed 34538623Ludot M, Merlo M, Ibrahim N, Piot MA, Lefevre H, Carles ME, Harf A, Moro MR. ["Somatic symptom disorders" in adolescence. A systematic review of the recent literature]. Encephale. 2021 Dec;47(6):596-604. doi: 10.1016/j.encep.2021.04.007. Epub 2021 Sep 16. French.
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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.
Maude LUDOT-GREGOIRE, MD, PhD principal investigator
Maison des Adolescents - Cochin Hospital - AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Somatic Symptoms and Medically Unexplained Symptoms, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maude LUDOT-GREGOIRE, MD, PhD (+33 1 58 41 24 26, maude.ludot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of healthcare events (time frame: Day of inclusion). 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 NCT06582173, which also lists 8 linked publications.
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 20 Jul 2026.