NCT04436757

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2023

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

3.3 years

First QC Date

June 16, 2020

Last Update Submit

July 30, 2025

Conditions

Keywords

severe mental disordersbody-esteembody-representationself-esteemsocio-professional insertion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Appreciation of the Self-esteem measured by the Self-Esteem Rating Scale

    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

    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 )

    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

    baseline, one month, three months, nine months after the end of the treatment

Study Arms (2)

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.

Behavioral: IPS program : Self-image and body representation

TAU

ACTIVE COMPARATOR

Treatment As Usual : the usual care proposed by the health service (SUR/CL3R).

Behavioral: TAU

Interventions

The 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

IPS (Self-image and body-representation program)
TAUBEHAVIORAL

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.

TAU

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, 69006, France

Location

MeSH Terms

Conditions

SchizophreniaBipolar DisorderPersonality DisordersAnxiety DisordersDepressive DisorderMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood Disorders

Study Officials

  • Lucie-Orianne PLAZAT, M.D

    Centre Hospitalier le Vinatier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 18, 2020

Study Start

June 22, 2020

Primary Completion

October 17, 2023

Study Completion

October 17, 2023

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations