Assessment of the Effectiveness of the NECT Program (NECT)

February 10, 2020 updated by: Dr Julien Dubreucq, Hospital Center Alpes-Isère

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Aura
      • Annecy, Aura, France, 74000
        • Recruiting
        • CH Annecy-Genevois
        • Contact:
          • Céline CR ROUSSEL, MD
        • Principal Investigator:
          • Céline CR ROUSSEL, MD
      • Bron, Aura, France, 69678
        • Recruiting
        • CH Le Vinatier
        • Contact:
          • Nicolas NF FRANCK, MD
        • Principal Investigator:
          • Nicolas NF FRANCK, MD
      • Clermont-Ferrand, Aura, France, 63000
        • Recruiting
        • CHU de Clermont-Ferrand
        • Contact:
          • ISABELLE IC CHEREAU, MD
        • Principal Investigator:
          • ISABELLE IC CHEREAU, MD
      • Grenoble, Aura, France, 38043
        • Recruiting
        • University Hospital, Grenoble
        • Contact:
        • Principal Investigator:
          • Mircea MP POLOSAN, MD
      • Limoges, Aura, France, 87000
        • Recruiting
        • CHS Esquirol
        • Contact:
          • Emilie EL LEGROS LAFARGE, MD
        • Principal Investigator:
          • Emilie EL LEGROS LAFARGE, MD
      • Seyssins, Aura, France, 38180
        • Recruiting
        • Clinique du Dauphiné
        • Contact:
        • Principal Investigator:
          • Elisabeth EG GIRAUD BARO, MD
      • Valence, Aura, France, 26000
        • Recruiting
        • Chs Le Valmont
        • Contact:
          • Motassem MB BAKRI, MD
        • Principal Investigator:
          • Motassem MB BAKRI, MD
        • Principal Investigator:
          • Mickael MB BACCONNIER, MD
        • Principal Investigator:
          • Didier DV VAQUETTE, DV
    • Normandie
      • Caen, Normandie, France, 14012
        • Recruiting
        • E.P.S.M. Ariane
        • Contact:
          • Elodie ED DECERLE, MD
        • Principal Investigator:
          • ELodie ED DECERLE, MD
    • Occitanie
      • Montpellier, Occitanie, France, 34000
        • Recruiting
        • Hopital La Colombière, University Hospital Montpellier
        • Contact:
          • Nicolas Rainteau, MD
        • Principal Investigator:
          • Nicolas Rainteau, MD
    • Paca
      • Nice, Paca, France, 06009
        • Recruiting
        • Hospital Center SAINTE MARIE
        • Contact:
          • Jean-Yves JG GIORDANA, MD
        • Principal Investigator:
          • Jean-Yves JG GIORDANA, MD
  • Switzerland
      • Geneva, Switzerland, 1201
        • Recruiting
        • Service des Specialités psychiatriques
        • Contact:
          • Hélène HR RICHARD LEPOURRIEL, MD
        • Principal Investigator:
          • Hélèné HR RICHARD LEPOURRIEL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NECT + follow up
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
PANSS, MADRS, PSP, YMRS
Other: Clinical, diagnostic and functional evaluation
ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS
Other: neuropsychological assessment
WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS
Other: NECT 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.
PLACEBO_COMPARATOR: TAU
  • 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
PANSS, MADRS, PSP, YMRS
Other: Clinical, diagnostic and functional evaluation
ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS
Other: neuropsychological assessment
WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS
Other: NECT 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal and Social Performance Scale
Time Frame: 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
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
Time Frame: 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)
Changes between baseline function, at 6, 12 and 18 months of follow-up
Positive and Negative Symptoms Scale for Schizophrenia (PANSS)
Time Frame: 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
Changes between baseline function, at 6, 12 and 18 months of follow-up
MADRS (Montgomery-Asberg Depression Rating)
Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
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
Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
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)
Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
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) )
Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
self assessment of mental well being
Changes between baseline function, at 6, 12 and 18 months of follow-up
SERS (Self-Esteem Rating Scale)
Time Frame: 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
Changes between baseline function, at 6, 12 and 18 months of follow-up
S-QOL (Subjective Quality of Life)
Time Frame: Changes between baseline function, at 6, 12 and 18 months of follow-up
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
Time Frame: 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
Changes between baseline function, at 6, 12 and 18 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Center Alpes-Isère

Collaborators

University Hospital, Geneva
University Hospital, Montpellier
University Hospital, Clermont-Ferrand
University Hospital, Caen
Centre Hospitalier Universitaire de Nice
University Hospital, Grenoble
Hôpital le Vinatier
Centre Hospitalier Esquirol
CH Annecy Genevois
Clinique du Dauphiné
CHS LE VALMONT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2020

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (ACTUAL)

June 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A03237-48

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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