NCT06582173

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress9%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

August 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

August 30, 2024

Last Update Submit

March 13, 2026

Conditions

Keywords

Somatic symptomsSomatoform disorderMedically unexplained symptomsHealthcare pathwayHealthcare trajectoryCare episodesHealth Care UtilizationAdolescentYoung Adult

Outcome Measures

Primary Outcomes (1)

  • Occurrence of healthcare events

    Successive healthcare events of individuals with somatic symptom disorder, from first symptoms to specialised multidisciplinary assessment

    Day of inclusion

Secondary Outcomes (7)

  • Raise of healthcare events occurrence

    Day of inclusion

  • Raise of life events occurrence

    Day of inclusion

  • Decrease of healthcare events occurrence

    Day of inclusion

  • Decrease of life events occurrence

    Day of inclusion

  • Modification of somatic symptoms occurrence

    Day of inclusion

  • +2 more secondary outcomes

Study Arms (2)

Adolescents

Patients aged 12 to 25 years old and diagnosed with SSD by a specialised multidisciplinary team

Other: Face-to-face interviews assisted by a biographical grid

Parents

Parents of an adolescent included

Other: Face-to-face interviews assisted by a biographical grid

Interventions

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

AdolescentsParents

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison de Solenn Maison des Adolescents, Cochin Hospital

Paris, IDF, 75014, France

Location

Related Publications (8)

  • 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.

    PMID: 26026696BACKGROUND
  • van 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.

    PMID: 25362239BACKGROUND
  • Wortman 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.

    PMID: 30321193BACKGROUND
  • Gosselin 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.

    PMID: 29437866BACKGROUND
  • Sawyer 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.

    PMID: 30169257BACKGROUND
  • Kachaner 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.

    PMID: 38105901BACKGROUND
  • Hinton 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.

    PMID: 25684117BACKGROUND
  • Ludot 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.

    PMID: 34538623BACKGROUND

MeSH Terms

Conditions

Medically Unexplained SymptomsSomatoform DisordersPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Maude LUDOT-GREGOIRE, MD, PhD

    Maison des Adolescents - Cochin Hospital - AP-HP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maude LUDOT-GREGOIRE, MD, PhD

CONTACT

Marie BENHAMMANI-GODARD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2024

First Posted

September 3, 2024

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations