An interventional study of Psychiatric interview and Clinical, diagnostic and functional evaluation in Schizophrenia, Bipolar Disorder and Borderline Personality Disorder, sponsored by Hospital Center Alpes-Isère. Status unknown at 11 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Hospital Center Alpes-Isère · Not applicable, Interventional, and Treatment
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)
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Hospital Center Alpes-Isère is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2 hours sessions are conducted by two trained facilitators.
Other: Psychiatric interview · Other: Clinical, diagnostic and functional evaluation · Other: neuropsychological assessment · Other: NECT PROGRAM
* Drug treatment (antipsychotic, mood stabilizing) for people with schizophrenia or with bipolar disorder * Support in day-care hospital * No intervention specifically targeting self-stigma reduction or improvements in social functioning (social cognitive remediation or social skills training)
Other: Psychiatric interview · Other: Clinical, diagnostic and functional evaluation · Other: neuropsychological assessment · Other: NECT PROGRAM
PANSS, MADRS, PSP, YMRS
ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS
WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS
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.
Personal and Social Performance Scale
Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after NECT Program
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
Internalized Stigma of Mental Illness (ISMI) scale
self-assessment of internalized stigma (mean score of total self-stigma ranging from 1 to 4)
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
Positive and Negative Symptoms Scale for Schizophrenia (PANSS)
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
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
MADRS (Montgomery-Asberg Depression Rating)
Changes in the aggregates (average) of standardized performance levels
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
BIRCHWOOD INSIGHT SCALE
Changes in the aggregates (average) of standardized performance levels
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
MARS (Medication Adherence Rating Scale)
self-assesment of adherence into treatment (minimum 1-maximum 10)
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
WEMWBS (Warwick Edinburgh Mental Well Being Scale) )
self assessment of mental well being
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
SERS (Self-Esteem Rating Scale)
Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
S-QOL (Subjective Quality of Life)
sel-assessment of quality of life (minimum 0, maximum 100)
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
STORI Stages of Recovery Instrument
Self-assessment of personal recovery (maximum stage of recovery ranging from 0 to 5
Time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Hospital Center Alpes-Isère