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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04436757
Other study ID # 2020-A00777-32
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 22, 2020
Est. completion date June 2023

Study information

Verified date August 2022
Source Hôpital le Vinatier
Contact Lucie-Orianne PLAZAT, M.D
Phone 0426738534
Email lucie-orianne.plazat@ch-le-vinatier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The body esteem influences the physical appearance, which can be a social brake. To enhance the socio-professional insertion of persons with severe mental disorders, the investigators developed a group program about self-presentation and body esteem. The study's objective is to understand the body esteem impact on socio-professional insertion, and how to improve that with a dedicated group program, for patients in a psychosocial rehabilitation center


Description:

Our hypothesis is that a group program centered on the image and the presentation of the self, with the intervention of professionals of the image of the body, such as socio-hairdresser, socio-beautician, allows a better socio-professional inclusion, through an improvement in body self-esteem. Taking care of yourself will require different approaches such as advice on hygiene, becoming aware of your body, experimenting with beauty treatments and having the means to reproduce them at home. We will compare our IPS program (Image and Presentation of Self), with the usual management in the care center (TAU = "Treatment As Usual")


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date June 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age 18 to 65. - Speaking French. - Diagnosis of severe mental disorders (MSD) established according to the criteria of the DSM-V (Diagnostic and Statistical Manual of Mental Disorders) such as: Schizophrenia, Bipolar Disorders, Serious Personality Disorders, Severe Anxiety Disorders, Depressive Disorders; with a clinical stability of more than 3 months. - Supported at SUR/CL3R with an application for socio-professional reintegration. - Guardian agreement (for persons under guardianship); - Information given to the curator (for persons under curatorship); - Member of the social security scheme. Exclusion Criteria: - Diagnosis of Autism Spectrum Disorder (ASD) or Eating Behaviour Disorder. - Clinical status incompatible with group activity. - Acute episode in progress. - Refusal to participate. - Simultaneous participation in a psycho-social rehabilitation program targeting image or self-esteem (general and/or body).

Study Design


Intervention

Behavioral:
IPS program : Self-image and body representation
The IPS program consists in 13 sessions of 2 hours over a 13-weeks period. Sessions content is as follows : : Introduction : Sensory approach workshop : Self presentation and personal hygiene : Organisation of well-being, planning and pictograms : Becoming aware of my body, my envelope : Presentation and self-esteem (photolanguage) : Self-presentation in social interactions: Social codes : My ideas and desires for change : Places of well-being and clothing hygiene : Vocational insertion devices : Daring change : presence of a Socio-hairdresser : The awakening of color : presence of a Socio-aesthetician : Development of practice sheets and the network
TAU
The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by the health service. No additional session will be proposed.

Locations

Country Name City State
France centre de réhabilitation - Hôpital le Vinatier Lyon Rhône

Sponsors (1)

Lead Sponsor Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Appreciation of one's own appearance The main judgement criterion is the difference before/after the program for each of the two groups (IPS and TAU) of the weighted average at the "satisfaction with overall appearance" and "wish to change appearance" dimensions of the BES (Body-Esteem Scale), common dimensions for men and women. This difference will be compared between the 2 groups by a Student test (or a Wilcoxon-Mann-Whitney test in case of non normality). baseline, one month, three months, nine months after the end of the treatment
Secondary Appreciation of the Self-esteem measured by the Self-Esteem Rating Scale As for the primary outcome baseline, one month, three months, nine months after the end of the treatment
Secondary Appreciation of the well-being measured by the Warwick-Edinburgh Well-Being Mental Scale As for the primary outcome baseline, one month, three months, nine months after the end of the treatment
Secondary Appreciation of the satisfaction level measured by the Client's Assessment of Strengths, Interests and Goals Scale (CASIG ) As for the primary outcome baseline, one month, three months, nine months after the end of the treatment
Secondary Appreciation of the satisfaction measured by the Satisfaction in the domains of life As for the primary outcome baseline, one month, three months, nine months after the end of the treatment
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