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Assessment of the Effectiveness of the NECT Program (NECT)

Primary Purpose

Schizophrenia, Bipolar Disorder, Borderline Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Psychiatric interview
Clinical, diagnostic and functional evaluation
neuropsychological assessment
NECT PROGRAM
Sponsored by
Hospital Center Alpes-Isère
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ch Annecy-GenevoisRecruiting
  • Ch Le VinatierRecruiting
  • CHU de CLERMONT-FERRANDRecruiting
  • University Hospital, GrenobleRecruiting
  • CHS EsquirolRecruiting
  • Clinique du DauphinéRecruiting
  • Chs Le ValmontRecruiting
  • E.P.S.M. ArianeRecruiting
  • Hopital La Colombière, University Hospital MontpellierRecruiting
  • Hospital Center SAINTE MARIERecruiting
  • Service des Specialités psychiatriquesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NECT + follow up

TAU

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Internalized Stigma of Mental Illness (ISMI) scale
self-assessment of internalized stigma (mean score of total self-stigma ranging from 1 to 4)
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
MADRS (Montgomery-Asberg Depression Rating)
Changes in the aggregates (average) of standardized performance levels
BIRCHWOOD INSIGHT SCALE
Changes in the aggregates (average) of standardized performance levels
MARS (Medication Adherence Rating Scale)
self-assesment of adherence into treatment (minimum 1-maximum 10)
WEMWBS (Warwick Edinburgh Mental Well Being Scale) )
self assessment of mental well being
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
S-QOL (Subjective Quality of Life)
sel-assessment of quality of life (minimum 0, maximum 100)
STORI Stages of Recovery Instrument
Self-assessment of personal recovery (maximum stage of recovery ranging from 0 to 5

Full Information

First Posted
May 31, 2019
Last Updated
February 10, 2020
Sponsor
Hospital Center Alpes-Isère
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03972735
Brief Title
Assessment of the Effectiveness of the NECT Program
Acronym
NECT
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Center Alpes-Isère
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Borderline Personality Disorder, Social Function, Self-stigma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
stepped-wedge
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NECT + follow up
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Psychiatric interview
Intervention Description
PANSS, MADRS, PSP, YMRS
Intervention Type
Other
Intervention Name(s)
Clinical, diagnostic and functional evaluation
Intervention Description
ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS
Intervention Type
Other
Intervention Name(s)
neuropsychological assessment
Intervention Description
WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS
Intervention Type
Other
Intervention Name(s)
NECT PROGRAM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Personal and Social Performance Scale
Description
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
Secondary Outcome Measure Information:
Title
Internalized Stigma of Mental Illness (ISMI) scale
Description
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
Title
Positive and Negative Symptoms Scale for Schizophrenia (PANSS)
Description
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
Title
MADRS (Montgomery-Asberg Depression Rating)
Description
Changes in the aggregates (average) of standardized performance levels
Time Frame
Changes between baseline function, at 6, 12 and 18 months of follow-up
Title
BIRCHWOOD INSIGHT SCALE
Description
Changes in the aggregates (average) of standardized performance levels
Time Frame
Changes between baseline function, at 6, 12 and 18 months of follow-up
Title
MARS (Medication Adherence Rating Scale)
Description
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
Title
WEMWBS (Warwick Edinburgh Mental Well Being Scale) )
Description
self assessment of mental well being
Time Frame
Changes between baseline function, at 6, 12 and 18 months of follow-up
Title
SERS (Self-Esteem Rating Scale)
Description
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
Title
S-QOL (Subjective Quality of Life)
Description
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
Title
STORI Stages of Recovery Instrument
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien JD DUBREUCQ, MD
Phone
+33 4 76 58 88 00
Email
jdubreucq@ch-alpes-isere.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas TC COHEN, CRA
Phone
+33 4 76 58 88 13
Email
tcohen@ch-alpes-isere.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien JD DUBREUCQ, MD
Organizational Affiliation
Hospital Center Alpes-Isère
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Annecy-Genevois
City
Annecy
State/Province
Aura
ZIP/Postal Code
74000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline CR ROUSSEL, MD
First Name & Middle Initial & Last Name & Degree
Céline CR ROUSSEL, MD
Facility Name
Ch Le Vinatier
City
Bron
State/Province
Aura
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas NF FRANCK, MD
First Name & Middle Initial & Last Name & Degree
Nicolas NF FRANCK, MD
Facility Name
CHU de CLERMONT-FERRAND
City
Clermont-Ferrand
State/Province
Aura
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ISABELLE IC CHEREAU, MD
First Name & Middle Initial & Last Name & Degree
ISABELLE IC CHEREAU, MD
Facility Name
University Hospital, Grenoble
City
Grenoble
State/Province
Aura
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mircea MP POLOSAN, MD
Email
mpolosan@chu-grenoble.Fr
First Name & Middle Initial & Last Name & Degree
Mircea MP POLOSAN, MD
Facility Name
CHS Esquirol
City
Limoges
State/Province
Aura
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie EL LEGROS LAFARGE, MD
First Name & Middle Initial & Last Name & Degree
Emilie EL LEGROS LAFARGE, MD
Facility Name
Clinique du Dauphiné
City
Seyssins
State/Province
Aura
ZIP/Postal Code
38180
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth EG GIRAUD BARO, MD
Email
egiraudbaro@orange.fr
First Name & Middle Initial & Last Name & Degree
Elisabeth EG GIRAUD BARO, MD
Facility Name
Chs Le Valmont
City
Valence
State/Province
Aura
ZIP/Postal Code
26000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Motassem MB BAKRI, MD
First Name & Middle Initial & Last Name & Degree
MD
First Name & Middle Initial & Last Name & Degree
Motassem MB BAKRI, MD
First Name & Middle Initial & Last Name & Degree
Mickael MB BACCONNIER, MD
First Name & Middle Initial & Last Name & Degree
Didier DV VAQUETTE, DV
Facility Name
E.P.S.M. Ariane
City
Caen
State/Province
Normandie
ZIP/Postal Code
14012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie ED DECERLE, MD
First Name & Middle Initial & Last Name & Degree
ELodie ED DECERLE, MD
Facility Name
Hopital La Colombière, University Hospital Montpellier
City
Montpellier
State/Province
Occitanie
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Rainteau, MD
First Name & Middle Initial & Last Name & Degree
Nicolas Rainteau, MD
Facility Name
Hospital Center SAINTE MARIE
City
Nice
State/Province
Paca
ZIP/Postal Code
06009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Yves JG GIORDANA, MD
First Name & Middle Initial & Last Name & Degree
Jean-Yves JG GIORDANA, MD
Facility Name
Service des Specialités psychiatriques
City
Geneva
ZIP/Postal Code
1201
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène HR RICHARD LEPOURRIEL, MD
First Name & Middle Initial & Last Name & Degree
Hélèné HR RICHARD LEPOURRIEL, MD

12. IPD Sharing Statement

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PubMed Identifier
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Citation
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Citation
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Assessment of the Effectiveness of the NECT Program

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