Assessment of the Effectiveness of the NECT Program

Study Overview
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Brief Summary
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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)

Official Title
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Randomized Controlled Study on the Efficacy of the NECT Program (Cognitive Therapy and Narrative Development) on Improving Social Functioning in People With Severe Psychic Disorders

Conditions
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Schizophrenia, Bipolar Disorder, Borderline Personality Disorder, Social Function, Self-stigma

Intervention / Treatment
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* Other: Psychiatric interview
* Other: Clinical, diagnostic and functional evaluation
* Other: neuropsychological assessment
* Other: NECT PROGRAM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: stepped-wedge
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NECT + follow up<br>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<br>* PANSS, MADRS, PSP, YMRS<br>Other: Clinical, diagnostic and functional evaluation<br>* ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS<br>Other: neuropsychological assessment<br>* WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS<br>Other: NECT PROGRAM<br>* 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.<br>|
| Placebo Comparator: TAU<br>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<br>* PANSS, MADRS, PSP, YMRS<br>Other: Clinical, diagnostic and functional evaluation<br>* ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS<br>Other: neuropsychological assessment<br>* WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS<br>Other: NECT PROGRAM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Changes between baseline function, at 6, 12 and 18 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internalized Stigma of Mental Illness (ISMI) scale | self-assessment of internalized stigma (mean score of total self-stigma ranging from 1 to 4) | 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 | 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 | 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 | 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) | 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 | 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 | 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) | 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 | Changes between baseline function, at 6, 12 and 18 months of follow-up |