Psychiatric Manifestations Associated With Behcet's Disease (PSYCHO-B7)

The psychoBehçet'study is aimed at evaluating the psychological and neurocognitive symptoms in 25 consecutive patients followed for Behçet's disease. This is a monocentric, observational, non interventional study.

Study Overview

• Status: Unknown
• Conditions: Behçet's Disease, neuroBehcet, Anxiety, Depression, Tiredness
• Intervention / Treatment: Other: Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of life

Detailed Description

Patients will be evaluated during a day-care facility for Behçet's disease activity together with evaluation of anxiety and depression symptoms (SCL90-R and MINI assessments), fatigue (MFI) and quality of life (SF36).

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Nicolas NN NOEL, MD PhD; Phone Number: + 33 1 45 21 27 57; Email: nicolas.noel@aphp.fr
• Study Contact Backup: Name: Fanny FU URBAIN, MD; Phone Number: + 33 1 45 21 27 57; Email: fanny.urbain@aphp.fr

Study Locations

• France
  • Val De Marne
    • Le Kremlin-Bicetre, Val De Marne, France, 94275
      • Internal medecine department
      • Contact: Nicolas NOEL, MD, PhD; Phone Number: + 331 45 21 27 57; Email: nicolas.noel@aphp.fr
      • Contact: Fanny URBAIN, MD; Phone Number: + 33 1 45 21 27 57; Email: fanny.urbain@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patient regularly monitored in the internal medicine department of Bicêtre

Description

Inclusion Criteria:

• Adult male or female
• Regular follow-up in the internal medicine department of Bicetre hospital
• Diagnosed with Behçet's disease

Exclusion Criteria:

• Refusal to participate in the study
• Poor command of the French language
• Patients under legal protection
• Pregnant woman

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patient with Behcet disease; adult patient with Behcet's disease followed regularly in the internal medicine department of Bicetre

Other: Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of life; Realization of specific questionnaires evaluating: psychiatric symptoms (self-assessment according to the SLC-90R questionnaire and hetero-assessment by the internist doctor of the center according to the M.I.N.I. questionnaire); fatigue (Multidimensional Fatigue Inventory (MFI-20), French version, in self-assessment); quality of life (SF36 self-assessment questionnaire)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCL90-R questionnaire	Anxiety/depression symptoms questionnaire	Inclusion visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MINI questionnaire	Anxiety/depression symptoms questionnaire	Inclusion visit
MFI questionnaire	Tiredness assessment	Inclusion visit
SF36 questionnaire	Quality of life	Inclusion visit
BSAS/BDCAF evaluation	Behçet's disease activity	Inclusion visit

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: NOEL NN Nicolas, MD PhD, APHP, Hôpital Bicetre

Study record dates

Study Major Dates

• Study Start (Anticipated): October 10, 2020
• Primary Completion (Anticipated): February 15, 2021
• Study Completion (Anticipated): February 15, 2021

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Behcet Syndrome
• Other Study ID Numbers: 2019-A01819-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No