- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04436757
Self and Body-esteem in Socio-professional Rehabilitation (IPS_FIRAH)
July 30, 2025 updated by: Hôpital le Vinatier
Group Program IPS: Body-esteem and Self-esteem in a Psycho-social Rehabilitation Perspective
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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")
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhône
-
Lyon, Rhône, France, 69006
- centre de réhabilitation - Hôpital le Vinatier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IPS (Self-image and body-representation program)
The IPS program (Self-image and body representation) was designed by Dr PLAZAT and coll.
for specific use with patients with severe mental disorders suffering of low self- and body-esteem and aiming at " reinsert themselves" in the society.
|
The IPS program consists in 13 sessions of 2 hours over a 13-weeks period. Sessions content is as follows :
|
|
Active Comparator: TAU
Treatment As Usual : the usual care proposed by the health service (SUR/CL3R).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appreciation of one's own appearance
Time Frame: baseline, one month, three months, nine months after the end of the treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appreciation of the Self-esteem measured by the Self-Esteem Rating Scale
Time Frame: baseline, one month, three months, nine months after the end of the treatment
|
As for the primary outcome
|
baseline, one month, three months, nine months after the end of the treatment
|
|
Appreciation of the well-being measured by the Warwick-Edinburgh Well-Being Mental Scale
Time Frame: baseline, one month, three months, nine months after the end of the treatment
|
As for the primary outcome
|
baseline, one month, three months, nine months after the end of the treatment
|
|
Appreciation of the satisfaction level measured by the Client's Assessment of Strengths, Interests and Goals Scale (CASIG )
Time Frame: baseline, one month, three months, nine months after the end of the treatment
|
As for the primary outcome
|
baseline, one month, three months, nine months after the end of the treatment
|
|
Appreciation of the satisfaction measured by the Satisfaction in the domains of life
Time Frame: baseline, one month, three months, nine months after the end of the treatment
|
As for the primary outcome
|
baseline, one month, three months, nine months after the end of the treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lucie-Orianne PLAZAT, M.D, Centre Hospitalier le Vinatier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2020
Primary Completion (Actual)
October 17, 2023
Study Completion (Actual)
October 17, 2023
Study Registration Dates
First Submitted
June 16, 2020
First Submitted That Met QC Criteria
June 16, 2020
First Posted (Actual)
June 18, 2020
Study Record Updates
Last Update Posted (Actual)
July 31, 2025
Last Update Submitted That Met QC Criteria
July 30, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A00777-32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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