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Assessment of Depression (iCGI) in Older People, According to Their Presentation in a Wheelchair or an Ordinary Chair. (WHEELDEP)

H

Hospital Center Guillaume Régnier

Status

Completed

Conditions

Depression in Old Age

Treatments

Other: Wheelchair

Study type

Interventional

Funder types

Other

Identifiers

NCT04979299
RC21_01GR_WHEELDEP

Details and patient eligibility

About

This study aims to test for a " wheelchair effect ", as a potential impact of stigma, during the evaluation of clinical global impression of depression.Elderly patients will be asked to sit in a wheelchair, or in a regular chair during recording a 5 minute video of spontaneous speech collected the iCGI semi-structured interview.

The videos are showed to 10 different psychiatrists whom each proceed to 10 iCGI rating assessments.The psychiatrists are blinded evaluators. They are not aware of the real objective of the study.

Full description

This is a multicentric, randomized study of depression severity assessments (by iCGI) for wheelchair sitting elderly patients versus regular chair sitting elderly patients.The iCGI is a validated scale to assess depression severity through 5 min videos viewing of semi-structured interviews. The frame of the interviews is made to obtain the material provided by the patients expected to facilitate the formation of an "impression", an empathetic feeling, based on phenomenological concepts. The clinical interview is close to day-to-day clinical practice.

Patients are randomized (1:1) into 2 groups: "wheelchair" group and control group.

After randomization, a 5-minute video of spontaneous speech collecting the semi-structured iCGI interview is recorded.

These videos will square the participant's face, torso, and thighs, with a ¾ angle, in order to visualise the patient and the chair he is sitting in. The face will not be blurred in order to access non his non-verbal communication.

The videos are viewed by 10 different psychiatrists whom each proceed to 10 iCGI rating assessments, The psychiatrists are blinded evaluators. They are not aware of the objective of the study focusing on the impact of the wheelchair. They will be decepted with the information that the study aim to evaluate the iCGI, as a new version of the CGI with elderly patients.

The 10 videos each psychiatrist have to assess are randomly selected following the next rules :

  • Un unbalanced number of wheelchair and regular chair videos, so as they don't guess the study directly focuses on the wheelchair.
  • The wheelchair/regular chair video ratio is 7/3 or 3/7 for each psychiatrist.
  • Each video is visualised once by one psychiatrist. Our objective is to highlight an assessment bias related to physical disability in depression in the elderly with the aim of improving the practices of all professionals involved.

Enrollment

100 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hospitalised or ambulatory patients
  • Suffering mild to severe depression, according to PHQ-9 (Patient Health Questionnaire-9) score ⩾ 5 [11].
  • Ability to understand the protocol.
  • Signed consent of the participant regarding the given information.
  • Subscription to the social security system.

Exclusion criteria

  • Walking disability (including walking with human help required).
  • Severe cognitive impairment diagnosed with MMSE (Mini Mental State Examination) score <18 within the last three months.
  • Historical or current schizophrenia diagnosis recorded on the medical file.
  • Historical or current neurological disease recorded on the medical file : Neurodegenerative disorders, stroke, epilepsy.
  • Patients under guardianship or trusteeship.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

wheelchair group
Experimental group
Description:
Patients included in the " wheelchair " group will be asked to sit in a wheelchair during the interview;
Treatment:
Other: Wheelchair
Control group
No Intervention group
Description:
Patients included in the control group will sit in a regular chair during the interview.

Trial contacts and locations

2

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Central trial contact

Nathalie AN ALLETON; Gabriel RG ROBERT, MD

Data sourced from clinicaltrials.gov

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