Assessment of the Effectiveness of the NECT Program

NCT03972735 | Unknown

• 1 other identifier: 2018-A03237-48
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 11

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)

Conditions

Schizophrenia; Bipolar Disorder; Borderline Personality Disorder; Social Function; Self-stigma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Internalized Stigma of Mental Illness (ISMI) scale

  Changes between baseline function, at 6, 12 and 18 months of follow-up

• Positive and Negative Symptoms Scale for Schizophrenia (PANSS)

  Changes between baseline function, at 6, 12 and 18 months of follow-up

• MADRS (Montgomery-Asberg Depression Rating)

  Changes between baseline function, at 6, 12 and 18 months of follow-up

• BIRCHWOOD INSIGHT SCALE

  Changes between baseline function, at 6, 12 and 18 months of follow-up

• MARS (Medication Adherence Rating Scale)

  Changes between baseline function, at 6, 12 and 18 months of follow-up

Study Arms (2)

NECT + follow up

EXPERIMENTAL

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

TAU

PLACEBO COMPARATOR

* 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

Interventions

Psychiatric interview OTHER

PANSS, MADRS, PSP, YMRS

NECT + follow up; TAU

Clinical, diagnostic and functional evaluation OTHER

ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS

NECT + follow up; TAU

neuropsychological assessment OTHER

WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS

NECT + follow up; TAU

NECT PROGRAM OTHER

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.

NECT + follow up; TAU

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

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

Study Sites (11)

Ch Annecy-Genevois

Annecy, AURA, 74000, France

RECRUITING

Ch Le Vinatier

Bron, Aura, 69678, France

RECRUITING

CHU de CLERMONT-FERRAND

Clermont-Ferrand, AURA, 63000, France

RECRUITING

University Hospital, Grenoble

Grenoble, AURA, 38043, France

RECRUITING

CHS Esquirol

Limoges, Aura, 87000, France

RECRUITING

Clinique du Dauphiné

Seyssins, AURA, 38180, France

RECRUITING

Chs Le Valmont

Valence, AURA, 26000, France

RECRUITING

E.P.S.M. Ariane

Caen, Normandy, 14012, France

RECRUITING

Hopital La Colombière, University Hospital Montpellier

Montpellier, Occitanie, 34000, France

RECRUITING

Hospital Center SAINTE MARIE

Nice, Paca, 06009, France

RECRUITING

Service des Specialités psychiatriques

Geneva, 1201, Switzerland

RECRUITING

Related Publications (15)

• Bellack AS, Brown SA. Psychosocial treatments for schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):407-12. doi: 10.1007/s11920-996-0035-x.

  PMID: 11559478 BACKGROUND

• Brohan E, Elgie R, Sartorius N, Thornicroft G; GAMIAN-Europe Study Group. Self-stigma, empowerment and perceived discrimination among people with schizophrenia in 14 European countries: the GAMIAN-Europe study. Schizophr Res. 2010 Sep;122(1-3):232-8. doi: 10.1016/j.schres.2010.02.1065. Epub 2010 Mar 26.

  PMID: 20347271 BACKGROUND

• Corrigan PW, Larson JE, Rusch N. Self-stigma and the "why try" effect: impact on life goals and evidence-based practices. World Psychiatry. 2009 Jun;8(2):75-81. doi: 10.1002/j.2051-5545.2009.tb00218.x.

  PMID: 19516923 BACKGROUND

• Corrigan PW, Kosyluk KA, Rusch N. Reducing self-stigma by coming out proud. Am J Public Health. 2013 May;103(5):794-800. doi: 10.2105/AJPH.2012.301037. Epub 2013 Mar 14.

  PMID: 23488488 BACKGROUND

• Dixon LB, Dickerson F, Bellack AS, Bennett M, Dickinson D, Goldberg RW, Lehman A, Tenhula WN, Calmes C, Pasillas RM, Peer J, Kreyenbuhl J; Schizophrenia Patient Outcomes Research Team (PORT). The 2009 schizophrenia PORT psychosocial treatment recommendations and summary statements. Schizophr Bull. 2010 Jan;36(1):48-70. doi: 10.1093/schbul/sbp115. Epub 2009 Dec 2.

  PMID: 19955389 BACKGROUND

• Fung KM, Tsang HW, Cheung WM. Randomized controlled trial of the self-stigma reduction program among individuals with schizophrenia. Psychiatry Res. 2011 Sep 30;189(2):208-14. doi: 10.1016/j.psychres.2011.02.013. Epub 2011 Mar 5.

  PMID: 21377738 BACKGROUND

• Lysaker PH, Bond G, Davis LW, Bryson GJ, Bell MD. Enhanced cognitive-behavioral therapy for vocational rehabilitation in schizophrenia: Effects on hope and work. J Rehabil Res Dev. 2005 Sep-Oct;42(5):673-82. doi: 10.1682/jrrd.2004.12.0157.

  PMID: 16586193 BACKGROUND

• Lysaker PH, Roe D, Yanos PT. Toward understanding the insight paradox: internalized stigma moderates the association between insight and social functioning, hope, and self-esteem among people with schizophrenia spectrum disorders. Schizophr Bull. 2007 Jan;33(1):192-9. doi: 10.1093/schbul/sbl016. Epub 2006 Aug 7.

  PMID: 16894025 BACKGROUND

• Rusch N, Lieb K, Bohus M, Corrigan PW. Self-stigma, empowerment, and perceived legitimacy of discrimination among women with mental illness. Psychiatr Serv. 2006 Mar;57(3):399-402. doi: 10.1176/appi.ps.57.3.399.

  PMID: 16525000 BACKGROUND

• Vauth R, Kleim B, Wirtz M, Corrigan PW. Self-efficacy and empowerment as outcomes of self-stigmatizing and coping in schizophrenia. Psychiatry Res. 2007 Feb 28;150(1):71-80. doi: 10.1016/j.psychres.2006.07.005. Epub 2007 Jan 30.

  PMID: 17270279 BACKGROUND

• Yanos PT, Roe D, Markus K, Lysaker PH. Pathways between internalized stigma and outcomes related to recovery in schizophrenia spectrum disorders. Psychiatr Serv. 2008 Dec;59(12):1437-42. doi: 10.1176/ps.2008.59.12.1437.

  PMID: 19033171 BACKGROUND

• Livingston JD, Boyd JE. Correlates and consequences of internalized stigma for people living with mental illness: a systematic review and meta-analysis. Soc Sci Med. 2010 Dec;71(12):2150-61. doi: 10.1016/j.socscimed.2010.09.030. Epub 2010 Oct 12.

  PMID: 21051128 RESULT

• Lucksted A, Drapalski AL, Brown CH, Wilson C, Charlotte M, Mullane A, Fang LJ. Outcomes of a Psychoeducational Intervention to Reduce Internalized Stigma Among Psychosocial Rehabilitation Clients. Psychiatr Serv. 2017 Apr 1;68(4):360-367. doi: 10.1176/appi.ps.201600037. Epub 2016 Dec 1.

  PMID: 27903136 RESULT

• Roe D, Hasson-Ohayon I, Mashiach-Eizenberg M, Derhy O, Lysaker PH, Yanos PT. Narrative enhancement and cognitive therapy (NECT) effectiveness: a quasi-experimental study. J Clin Psychol. 2014 Apr;70(4):303-12. doi: 10.1002/jclp.22050. Epub 2013 Oct 2.

  PMID: 24114797 RESULT

• Dubreucq J, Faraldo M, Abbes M, Ycart B, Richard-Lepouriel H, Favre S, Jermann F, Attal J, Bakri M, Cohen T, Cervello C, Chereau I, Cognard C, De Clercq M, Douasbin A, Giordana JY, Giraud-Baro E, Guillard-Bouhet N, Legros-Lafarge E, Polosan M, Pouchon A, Rolland M, Rainteau N, Roussel C, Wangermez C, Yanos PT, Lysaker PH, Franck N. Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial. Trials. 2021 Feb 8;22(1):124. doi: 10.1186/s13063-021-05067-1.

  PMID: 33557924 DERIVED

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Borderline Personality Disorder; Social Adjustment

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Personality Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Julien JD DUBREUCQ, MD

  Hospital Center Alpes-Isère

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien JD DUBREUCQ, MD

CONTACT

+33 4 76 58 88 00; jdubreucq@ch-alpes-isere.fr

Thomas TC COHEN, CRA

CONTACT

+33 4 76 58 88 13; tcohen@ch-alpes-isere.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: stepped-wedge

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: February 10, 2020
• Primary Completion: September 1, 2022
• Study Completion: April 1, 2023
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

FR (10); CH (1)