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Depression in Old AgeWHEELDEPNCT04979299

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

A study testing Wheelchair in people with Depression in Old Age, run by Hospital Center Guillaume Régnier at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Depression in Old Age
What is being tested?
Wheelchair
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesFrance
Study dates
22 Nov 2021to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Hospitalier Guillaume Regnier

    Rennes, Ile Et Vilaine, 35000

  • EPSM Saint Avé

    Saint-Avé, Brittany Region, 56890

Other trials in France

About this study

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

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.

Read the 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.
Being tested
Wheelchair
Keywords
elderly depression, stigma, iCGI
Medical subject headings
Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WheelchairOther

    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.

Study groups in NCT04979299
Study groupRoleWhat they receive
wheelchair groupExperimentalPatients included in the " wheelchair " group will be asked to sit in a wheelchair during the interview;
Receives: Other: Wheelchair
Control groupNo interventionPatients included in the control group will sit in a regular chair during the interview.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: after including all patients in the study, up to 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2021
  2. Study start22 Nov 2021
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04979299
Sponsor's protocol ID
RC21_01GR_WHEELDEP
Acronym
WHEELDEP
Status last verified
Jun 2024
First submitted
15 Jul 2021
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data about study protocol and clinical information will be available on request from other researchers.

Publications

  • 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.

    PubMed 21896496

  • 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.

    PubMed 26361202

  • 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.

    PubMed 4809670

  • 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.

    PubMed 28572626

  • 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.

    PubMed 17284321

  • 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.

    PubMed 22592503

  • 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.

    PubMed 11556941

Questions about this trial

What is this clinical trial studying?

A study testing Wheelchair in people with Depression in Old Age, run by Hospital Center Guillaume Régnier at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

psychiatrists' assessment of depression severity with the iCGI scale (time frame: after including all patients in the study, up to 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04979299, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.

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