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

Depression in Old Age Clinical Trial

— WHEELDEP  

Official title:

Assessment of Depression in the Elderly : a Bias Related to the Stigmatisation of Patients Presenting in Wheelchairs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979299
• Other study ID #: RC21_01GR_WHEELDEP
• Status: Completed
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2024
• Source: Hospital Center Guillaume Régnier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression in Old Age
• Depressive Disorder

Intervention

Other:
• Wheelchair
Patient will be asked to sit in a wheelchair, and a 5-minute video recording of spontaneous speech capturing the semi-structured iCGI interview is made.

Locations

Country	Name	City	State
France	Centre Hospitalier Guillaume Regnier	Rennes	Ile Et Vilaine
France	EPSM Saint Avé	Saint-Avé	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Center Guillaume Régnier

Country where clinical trial is conducted

France, 

References & Publications (7)

Delmas H, Batail JM, Falissard B, Robert G, Range M, Brousse S, Soulabaille J, Drapier D, Naudet F. A randomised cross-over study assessing the "blue pyjama syndrome" in major depressive episode. Sci Rep. 2017 Jun 1;7(1):2629. doi: 10.1038/s41598-017-02411-x. — View Citation

Henderson C, Noblett J, Parke H, Clement S, Caffrey A, Gale-Grant O, Schulze B, Druss B, Thornicroft G. Mental health-related stigma in health care and mental health-care settings. Lancet Psychiatry. 2014 Nov;1(6):467-82. doi: 10.1016/S2215-0366(14)00023-6. Epub 2014 Nov 5. — View Citation

Kadouri A, Corruble E, Falissard B. The improved Clinical Global Impression Scale (iCGI): development and validation in depression. BMC Psychiatry. 2007 Feb 6;7:7. doi: 10.1186/1471-244X-7-7. — View Citation

Krendl AC, Kensinger EA, Ambady N. How does the brain regulate negative bias to stigma? Soc Cogn Affect Neurosci. 2012 Aug;7(6):715-26. doi: 10.1093/scan/nsr046. Epub 2011 Sep 5. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Laux G; VIVALDI Study Group. The antidepressant agomelatine in daily practice: results of the non-interventional study VIVALDI. Pharmacopsychiatry. 2012 Nov;45(7):284-91. doi: 10.1055/s-0032-1309003. Epub 2012 May 16. — View Citation

MacDonald ML, Butler AK. Reversal of helplessness: producing walking behavior in nursing home wheelchair residents using behavior modification procedures. J Gerontol. 1974 Jan;29(1):97-101. doi: 10.1093/geronj/29.1.97. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychiatrists' assessment of depression severity with the iCGI scale	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.	after including all patients in the study, up to 24 month