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

Not Applicable

Completed

• Conditions: Depression in Old Age
• Interventions: Other: Wheelchair

• Registration Number: NCT04979299
• Lead Sponsor: Hospital Center Guillaume Régnier

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-28
• Study Start: 2021-11-22
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
wheelchair group	Wheelchair	Patients included in the " wheelchair " group will be asked to sit in a wheelchair during the interview;

Primary Outcome Measures

Name	Time	Method
psychiatrists' assessment of depression severity with the iCGI scale	after including all patients in the study, up to 24 month	The iCGI is a validated scale to assess depression severity through 5 min videos viewing of semi-structured interviews. We will compare the iCGI in the " wheelchair " group and the control group. Analyzes will be based on each group's mean score.

Trial Locations

Locations (2)

Centre Hospitalier Guillaume Regnier; 🇫🇷 Rennes, Ile Et Vilaine, France

EPSM Saint Avé; 🇫🇷 Saint-Avé, Bretagne, France