SchizophreniaIPS_FIRAHNCT04436757
Self and Body-esteem in Socio-professional Rehabilitation
A study testing IPS program : Self-image and body representation and TAU in people with Schizophrenia and Bipolar Disorder, run by Hôpital le Vinatier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Personality Disorders
- What is being tested?
- IPS program : Self-image and body representation and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2020to 17 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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")
- Conditions
- Schizophrenia, Bipolar Disorder, Personality Disorders, Anxiety Disorders, Depressive Disorder
- Being tested
- IPS program : Self-image and body representation, TAU
- Keywords
- severe mental disorders, body-esteem, body-representation, self-esteem, socio-professional insertion
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Personality Disorders, Anxiety Disorders, Depressive Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPS program : Self-image and body representationBehavioural
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
TAUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| IPS (Self-image and body-representation program) | Experimental | 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. Receives: Behavioral: IPS program : Self-image and body representation |
| TAU | Active comparator | Treatment As Usual : the usual care proposed by the health service (SUR/CL3R). Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, one month, three months, nine months after the end of the treatment
Secondary outcomes (4)
Appreciation of the Self-esteem measured by the Self-Esteem Rating Scale
As for the primary outcome
Measured: 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
As for the primary outcome
Measured: 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 )
As for the primary outcome
Measured: 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
As for the primary outcome
Measured: baseline, one month, three months, nine months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start22 Jun 2020
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucie-Orianne PLAZAT, M.D, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436757
- Sponsor's protocol ID
- 2020-A00777-32
- Acronym
- IPS_FIRAH
- Status last verified
- Jul 2025
- First submitted
- 16 Jun 2020
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Program IPS: Body-esteem and Self-esteem in a Psycho-social Rehabilitation Perspective
- ClinicalTrials.gov ID
- NCT04436757
- Acronym / sponsor ID
- IPS_FIRAH / 2020-A00777-32
- Conditions
- Schizophrenia, Bipolar Disorder, Personality Disorders, Anxiety Disorders, Depressive Disorder
- Keywords
- severe mental disorders, body-esteem, body-representation, self-esteem, socio-professional insertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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")
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| IPS (Self-image and body-representation program) | Experimental | Behavioral: IPS program : Self-image and body representationThe 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. |
| TAU | Active comparator | Behavioral: TAUTreatment As Usual : the usual care proposed by the health service (SUR/CL3R). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPS program : Self-image and body representationThe IPS program consists in 13 sessions of 2 hours over a 13-weeks period. Sessions content is as follows : 1. : Introduction 2. : Sensory approach workshop 3. : Self presentation and personal hygiene 4. : Organisation of well-being, planning and pictograms 5. : Becoming aware of my body, my envelope 6. : Presentation and self-esteem (photolanguage) 7. : Self-presentation in social interactions: Social codes 8. : My ideas and desires for change 9. : Places of well-being and clothing hygiene 10. : Vocational insertion devices 11. : Daring change : presence of a Socio-hairdresser 12. : The awakening of color : presence of a Socio-aesthetician 13. : Development of practice sheets and the network | Behavioural | IPS (Self-image and body-representation program) |
| TAUThe 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. | Behavioural | TAU |
Primary outcome
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).
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucie-Orianne PLAZAT, M.D principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPS program : Self-image and body representation and TAU in people with Schizophrenia and Bipolar Disorder, run by Hôpital le Vinatier at 1 site 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 7 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Appreciation of one's own appearance (time frame: baseline, one month, three months, nine months after the end of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.