Back to resultsSelf and Body-esteem in Socio-professional Rehabilitation (IPS_FIRAH)
Primary Purpose
Schizophrenia, Bipolar Disorder, Personality Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IPS program : Self-image and body representation
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring severe mental disorders, body-esteem, body-representation, self-esteem, socio-professional insertion
Eligibility Criteria
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).
Sites / Locations
- centre de réhabilitation - Hôpital le VinatierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IPS (Self-image and body-representation program)
TAU
Arm Description
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.
Treatment As Usual : the usual care proposed by the health service (SUR/CL3R).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Appreciation of the Self-esteem measured by the Self-Esteem Rating Scale
As for the primary outcome
Appreciation of the well-being measured by the Warwick-Edinburgh Well-Being Mental Scale
As for the primary outcome
Appreciation of the satisfaction level measured by the Client's Assessment of Strengths, Interests and Goals Scale (CASIG )
As for the primary outcome
Appreciation of the satisfaction measured by the Satisfaction in the domains of life
As for the primary outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04436757
Brief Title
Self and Body-esteem in Socio-professional Rehabilitation
Acronym
IPS_FIRAH
Official Title
Group Program IPS: Body-esteem and Self-esteem in a Psycho-social Rehabilitation Perspective
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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")
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Personality Disorders, Anxiety Disorders, Depressive Disorder
Keywords
severe mental disorders, body-esteem, body-representation, self-esteem, socio-professional insertion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single-centre, comparative, interventional study, treated in open parallel groups, measuring the impact of "professional" body image intervention on improving body self-esteem in patients with severe mental health problems.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPS (Self-image and body-representation program)
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Treatment As Usual : the usual care proposed by the health service (SUR/CL3R).
Intervention Type
Behavioral
Intervention Name(s)
IPS program : Self-image and body representation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Appreciation of one's own appearance
Description
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).
Time Frame
baseline, one month, three months, nine months after the end of the treatment
Secondary Outcome Measure Information:
Title
Appreciation of the Self-esteem measured by the Self-Esteem Rating Scale
Description
As for the primary outcome
Time Frame
baseline, one month, three months, nine months after the end of the treatment
Title
Appreciation of the well-being measured by the Warwick-Edinburgh Well-Being Mental Scale
Description
As for the primary outcome
Time Frame
baseline, one month, three months, nine months after the end of the treatment
Title
Appreciation of the satisfaction level measured by the Client's Assessment of Strengths, Interests and Goals Scale (CASIG )
Description
As for the primary outcome
Time Frame
baseline, one month, three months, nine months after the end of the treatment
Title
Appreciation of the satisfaction measured by the Satisfaction in the domains of life
Description
As for the primary outcome
Time Frame
baseline, one month, three months, nine months after the end of the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie-Orianne PLAZAT, M.D
Phone
0426738534
Ext
+33
Email
lucie-orianne.plazat@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel GAUTHIER, Ph.D.
Phone
0426738533
Ext
+33
Email
emmanuel.gauthier@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucie-Orianne PLAZAT, M.D
Organizational Affiliation
Centre Hospitalier le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
centre de réhabilitation - Hôpital le Vinatier
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69006
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Nicolas, PUPH
Phone
+33 (0)4 26 23 76 11
Email
nicolas.franck@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Gaudelus Baptiste
Phone
+33 (0)4 26 23 76 11
Email
baptiste.gaudelus@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Franck Nicolas
12. IPD Sharing Statement
Plan to Share IPD
No
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Self and Body-esteem in Socio-professional Rehabilitation
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