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

NCT04979299 | Completed

• 1 other identifier: RC21_01GR_WHEELDEP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression in Old Age

Keywords

elderly depression; stigma; iCGI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

wheelchair group

EXPERIMENTAL

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

Other: Wheelchair

Control group

NO INTERVENTION

Patients included in the control group will sit in a regular chair during the interview.

Interventions

Wheelchair OTHER

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.

wheelchair group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Center Guillaume Régnier: lead

Study Sites (2)

EPSM Saint Avé

Saint-Avé, Brittany Region, 56890, France

Location

Centre Hospitalier Guillaume Regnier

Rennes, Ile Et Vilaine, 35000, France

Location

Related Publications (7)

• 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.

  PMID: 21896496 BACKGROUND

• 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.

  PMID: 26361202 BACKGROUND

• 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.

  PMID: 4809670 BACKGROUND

• 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.

  PMID: 28572626 BACKGROUND

• 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.

  PMID: 17284321 BACKGROUND

• 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.

  PMID: 22592503 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

MeSH Terms

Conditions

Social Stigma

Interventions

Wheelchairs

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Self-Help Devices; Equipment and Supplies

Study Officials

• Gabriel RG ROBERT, MD

  Centre Hospitalier Guillaume Régnier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants included in the wheelchair group settle into a hospital wheelchair. The wheelchair comes from a batch of two, without specific brand, standard color. The videos are showed to 10 different psychiatrists whom each proceed to 10 iCGI rating assessments, after receiving methodological informations. 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 (we will procede to a feedback afterward).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 28, 2021
• Study Start: November 22, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be availablefrom the moment a scientific publication is accepted to five years later.
• Access Criteria: acces to data will be granted to researchers aiming to perform another analysis or to review the topic, or to perform a meta-analysis.

Locations

FR (2)