Bipolar Disorder, Borderline Personality Disorder, Schizophrenia, Self-stigma, Social Function
Conditions
Brief summary
Self-stigma refers to the transformation process wherein a person's previously held social identity is progressively replaced by a devalued and stigmatized view of oneself termed illness identity. Self-Stigma is a severe problem in Serious Mental Illness (SMI). Self-stigma prevalence is high (41.7% of the 1229 participants with SZ and 21.7% of the 1182 participants with mood disorders had moderate to high levels of IS in the GAMIAN-Europe study). Self-stigma was negatively associated with self-esteem, social function, wellbeing, quality of life or personal recovery and positively associated with psychiatric symptoms and depression. Several psychosocial interventions (mostly combinations of psychoeducation and cognitive behaviour therapy) have been designed to reduce self-stigma and its impact on clinical and functional outcomes, with preliminary effects on self-stigma, insight and self-efficacy. Narrative Enhancement and Cognitive Therapy (NECT) is a manualized structured 20-session group-based intervention . Conducted by two trained facilitators the sessions combine psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma. Developed in USA, NECT was adapted in Israel and Sweden. NECT showed effectiveness in reducing self-stigma and in improving self-esteem and quality of life. Despite being effective on changing coping strategies, NECT effectiveness on social function is still unclear. The present study aims to validate NECT French adaptation and to evaluate its effectiveness on social function, self-stigma, psychiatric symptoms, self-esteem, wellbeing, quality of life and personal recovery in SMI participants (schizophrenia, bipolar disorder, borderline personality disorder)
Interventions
PANSS, MADRS, PSP, YMRS
OTHERClinical, diagnostic and functional evaluation
ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS
OTHERneuropsychological assessment
WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS
OTHERNECT PROGRAM
Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2h sessions are conducted by two trained facilitators.
Sponsors
Hôpital le Vinatier
University Hospital, Grenoble
Clinique du Dauphiné
CH Annecy Genevois
University Hospital, Clermont-Ferrand
Centre Hospitalier Esquirol
Centre Hospitalier Universitaire de Nice
CHS LE VALMONT
University Hospital, Caen
University Hospital, Geneva
University Hospital, Montpellier
Hospital Center Alpes-Isère
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
stepped-wedge
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, bipolar I or II disorder, borderline personality disorder (DSM-V criteria, APA, 2013). * Clinical stability since 3 months (total PANSS score \<120, MADRS score \<15 and YMRS \<12 for patients with schizophrenia and MADRS score \<15 and YMRS \<12 for patients with bipolar disorder). * Patients who gave informed consent to participate in the study. * Affiliated to a social security scheme or beneficiary of such a scheme.
Exclusion criteria
* Pregnant or lactating women. * Criteria relating to the associated pathologies entailing particular risks: * Neurological disorders of vascular, infectious or neurodegenerative origin. * Taking somatic drugs with a cerebral or mental impact (eg corticosteroids). * Presence of an associated intellectual disability. * Prohibited treatments and procedures: * Subject in exclusion period of another study. * Simultaneous participation in other programs having an impact on social functioning or self-stigmatization: remediation of social cognition, individual and group care targeting self-stigmatization and training in social skills.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Personal and Social Performance Scale | Changes between baseline function, at 6, 12 and 18 months of follow-up | Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after NECT Program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Symptoms Scale for Schizophrenia (PANSS) | Changes between baseline function, at 6, 12 and 18 months of follow-up | Changes in the aggregates (average) of standardized performance levels : z-scores of positive and negative symptoms (minimum score 30- maximum score 210) of schizophrenia after NECT Program |
| MADRS (Montgomery-Asberg Depression Rating) | Changes between baseline function, at 6, 12 and 18 months of follow-up | Changes in the aggregates (average) of standardized performance levels |
| BIRCHWOOD INSIGHT SCALE | Changes between baseline function, at 6, 12 and 18 months of follow-up | Changes in the aggregates (average) of standardized performance levels |
| MARS (Medication Adherence Rating Scale) | Changes between baseline function, at 6, 12 and 18 months of follow-up | self-assesment of adherence into treatment (minimum 1-maximum 10) |
| Internalized Stigma of Mental Illness (ISMI) scale | Changes between baseline function, at 6, 12 and 18 months of follow-up | self-assessment of internalized stigma (mean score of total self-stigma ranging from 1 to 4) |
| SERS (Self-Esteem Rating Scale) | Changes between baseline function, at 6, 12 and 18 months of follow-up | Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem |
| S-QOL (Subjective Quality of Life) | Changes between baseline function, at 6, 12 and 18 months of follow-up | sel-assessment of quality of life (minimum 0, maximum 100) |
| STORI Stages of Recovery Instrument | Changes between baseline function, at 6, 12 and 18 months of follow-up | Self-assessment of personal recovery (maximum stage of recovery ranging from 0 to 5 |
| WEMWBS (Warwick Edinburgh Mental Well Being Scale) ) | Changes between baseline function, at 6, 12 and 18 months of follow-up | self assessment of mental well being |
Countries
France, Switzerland
Contacts
Primary ContactJulien JD DUBREUCQ, MD
Backup ContactThomas TC COHEN, CRA
Outcome results
None listed