Clinical trial NCT04979299: Assessment of Depression (iCGI) in Older People, According to Their Presentation in a Wheelchair or an Ordinary Chair.
Official title: Assessment of Depression in the Elderly : a Bias Related to the Stigmatisation of Patients Presenting in Wheelchairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression in Old Age
Keywords: elderly depression
stigma
iCGI
Lead sponsor: Hospital Center Guillaume Régnier
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We procede in a randomization 1:1, stratified by site. In one group, patients will be seated in a wheelchair and in the second group, patients will be seated in an regular chair. Allocation concealment will be ensured by the use of sequentially numbered, opaque, sealed envelopes (SNOSE).
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: psychiatrists' assessment of depression severity with the iCGI scale
timeFrame: after including all patients in the study, up to 24 month
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Avé
country: France
facility: EPSM Saint Avé
state: Bretagne
city: Rennes
country: France
facility: Centre Hospitalier Guillaume Regnier
state: Ile Et Vilaine
Study officials:
affiliation: Centre Hospitalier Guillaume Régnier
name: Gabriel RG ROBERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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.
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.