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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wheelchair group | Experimental | Patients included in the " wheelchair " group will be asked to sit in a wheelchair during the interview; |
|
| Control group | No Intervention | Patients included in the control group will sit in a regular chair during the interview. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel RG ROBERT, MD | Centre Hospitalier Guillaume Régnier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EPSM Saint Avé | Saint-Avé | Brittany Region | 56890 | France | ||
| Centre Hospitalier Guillaume Regnier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21896496 | Background | 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. | |
| 26361202 | 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. |
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Data about study protocol and clinical information will be available on request from other researchers.
Data will be availablefrom the moment a scientific publication is accepted to five years later.
acces to data will be granted to researchers aiming to perform another analysis or to review the topic, or to perform a meta-analysis.
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| ID | Term |
|---|---|
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014910 | Wheelchairs |
| ID | Term |
|---|---|
| D012656 | Self-Help Devices |
| D004864 | Equipment and Supplies |
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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).
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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).
| Rennes |
| Ile Et Vilaine |
| 35000 |
| France |
| 4809670 | 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. |
| 28572626 | 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. |
| 17284321 | 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. |
| 22592503 | 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. |
| 11556941 | 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. |