Clinical trial NCT03972735: Assessment of the Effectiveness of the NECT Program
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Borderline Personality Disorder
Social Function
Self-stigma
Lead sponsor: Hospital Center Alpes-Isère
Sponsor class: OTHER
Collaborators: name: Hôpital le Vinatier
name: University Hospital, Grenoble
name: Clinique du Dauphiné
name: CH Annecy Genevois
name: University Hospital, Clermont-Ferrand
name: Centre Hospitalier Esquirol
name: Centre Hospitalier Universitaire de Nice
name: CHS LE VALMONT
name: University Hospital, Caen
name: University Hospital, Geneva
name: University Hospital, Montpellier
First posted: 2019-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: stepped-wedge
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Personal and Social Performance Scale
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
Secondary outcomes:
measure: Internalized Stigma of Mental Illness (ISMI) scale
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
measure: Positive and Negative Symptoms Scale for Schizophrenia (PANSS)
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
measure: MADRS (Montgomery-Asberg Depression Rating)
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
measure: BIRCHWOOD INSIGHT SCALE
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
measure: MARS (Medication Adherence Rating Scale)
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
measure: WEMWBS (Warwick Edinburgh Mental Well Being Scale) )
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
measure: SERS (Self-Esteem Rating Scale)
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
measure: S-QOL (Subjective Quality of Life)
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
measure: STORI Stages of Recovery Instrument
timeFrame: Changes between baseline function, at 6, 12 and 18 months of follow-up
Other outcomes:
Locations:
city: Annecy
country: France
facility: Ch Annecy-Genevois
state: Aura
city: Bron
country: France
facility: Ch Le Vinatier
state: Aura
city: Clermont-Ferrand
country: France
facility: CHU de CLERMONT-FERRAND
state: Aura
city: Grenoble
country: France
facility: University Hospital, Grenoble
state: Aura
city: Limoges
country: France
facility: CHS Esquirol
state: Aura
city: Seyssins
country: France
facility: Clinique du Dauphiné
state: Aura
city: Valence
country: France
facility: Chs Le Valmont
state: Aura
city: Caen
country: France
facility: E.P.S.M. Ariane
state: Normandie
city: Montpellier
country: France
facility: Hopital La Colombière, University Hospital Montpellier
state: Occitanie
city: Nice
country: France
facility: Hospital Center SAINTE MARIE
state: Paca
city: Geneva
country: Switzerland
facility: Service des Specialités psychiatriques
Study officials:
affiliation: Hospital Center Alpes-Isère
name: Julien JD DUBREUCQ, MD
role: PRINCIPAL_INVESTIGATOR
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