Assessment of the Effectiveness of the NECT Program

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03972735
• Other study ID #: 2018-A03237-48
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2020
• Source: Hospital Center Alpes-Isère
• Contact: Julien JD DUBREUCQ, MD
• Phone: +33 4 76 58 88 00
• Email: jdubreucq[@]ch-alpes-isere.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Borderline Personality Disorder
• Disease
• Personality Disorders
• Schizophrenia
• Self-stigma
• Social Function

Intervention

Other:
• Psychiatric interview
PANSS, MADRS, PSP, YMRS
• Clinical, diagnostic and functional evaluation
ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS
• neuropsychological assessment
WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS
• 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.

Locations

Country	Name	City	State
France	Ch Annecy-Genevois	Annecy	Aura
France	Ch Le Vinatier	Bron	Aura
France	E.P.S.M. Ariane	Caen	Normandie
France	CHU de CLERMONT-FERRAND	Clermont-Ferrand	Aura
France	University Hospital, Grenoble	Grenoble	Aura
France	CHS Esquirol	Limoges	Aura
France	Hopital La Colombière, University Hospital Montpellier	Montpellier	Occitanie
France	Hospital Center SAINTE MARIE	Nice	Paca
France	Clinique du Dauphiné	Seyssins	Aura
France	Chs Le Valmont	Valence	Aura
Switzerland	Service des Specialités psychiatriques	Geneva

Sponsors (12)

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

Countries where clinical trial is conducted

France,  Switzerland, 

References & Publications (14)

Bellack AS, Brown SA. Psychosocial treatments for schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):407-12. Review. — View Citation

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. — View Citation

Corrigan PW, Kosyluk KA, Rüsch 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. Review. — View Citation

Corrigan PW, Larson JE, Rüsch N. Self-stigma and the "why try" effect: impact on life goals and evidence-based practices. World Psychiatry. 2009 Jun;8(2):75-81. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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/app — View Citation

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. — View Citation

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. Epub 2006 Aug 7. — View Citation

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. — View Citation

Rüsch 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. — View Citation

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. Epub 2007 Jan 30. — View Citation

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/appi.ps.59.12.1437. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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