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SchizophreniaNECTNCT03972735

Assessment of the Effectiveness of the NECT Program

A study testing Psychiatric interview, Clinical, diagnostic and functional evaluation and neuropsychological assessment in people with Schizophrenia and Bipolar Disorder, run by Hospital Center Alpes-Isère at 11 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Psychiatric interview, Clinical, diagnostic and functional evaluation and neuropsychological assessment
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
11 sitesin 2 countries
Study dates
10 Feb 2020to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 2 countries.

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

11 sites in 2 countries

France10 sites, 10 recruiting

  • Ch Annecy-Genevois

    Annecy, AURA, 74000

    Céline CR ROUSSEL, MD

    Céline CR ROUSSEL, MD

    Recruiting

  • Ch Le Vinatier

    Bron, Aura, 69678

    Nicolas NF FRANCK, MD

    Nicolas NF FRANCK, MD

    Recruiting

  • E.P.S.M. Ariane

    Caen, Normandy, 14012

    Elodie ED DECERLE, MD

    ELodie ED DECERLE, MD

    Recruiting

  • CHU de CLERMONT-FERRAND

    Clermont-Ferrand, AURA, 63000

    ISABELLE IC CHEREAU, MD

    ISABELLE IC CHEREAU, MD

    Recruiting

  • University Hospital, Grenoble

    Grenoble, AURA, 38043

    Mircea MP POLOSAN, MD, mpolosan@chu-grenoble.Fr

    Mircea MP POLOSAN, MD

    Recruiting

  • CHS Esquirol

    Limoges, Aura, 87000

    Emilie EL LEGROS LAFARGE, MD

    Emilie EL LEGROS LAFARGE, MD

    Recruiting

  • Hopital La Colombière, University Hospital Montpellier

    Montpellier, Occitanie, 34000

    Nicolas Rainteau, MD

    Nicolas Rainteau, MD

    Recruiting

  • Hospital Center SAINTE MARIE

    Nice, Paca, 06009

    Jean-Yves JG GIORDANA, MD

    Jean-Yves JG GIORDANA, MD

    Recruiting

  • Clinique du Dauphiné

    Seyssins, AURA, 38180

    Elisabeth EG GIRAUD BARO, MD, egiraudbaro@orange.fr

    Elisabeth EG GIRAUD BARO, MD

    Recruiting

  • Chs Le Valmont

    Valence, AURA, 26000

    Motassem MB BAKRI, MD

    MD

    Recruiting

Other trials in France

Switzerland1 site, 1 recruiting

  • Service des Specialités psychiatriques

    Geneva, 1201

    Hélène HR RICHARD LEPOURRIEL, MD

    Hélèné HR RICHARD LEPOURRIEL, MD

    Recruiting

Other trials in Switzerland

About this study

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

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)

Being tested
Psychiatric interview, Clinical, diagnostic and functional evaluation, neuropsychological assessment, NECT PROGRAM
Medical subject headings
Schizophrenia, Bipolar Disorder, Borderline Personality Disorder, Social Adjustment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychiatric interviewOther

    PANSS, MADRS, PSP, YMRS

  • Clinical, diagnostic and functional evaluationOther

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

  • neuropsychological assessmentOther

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

  • NECT PROGRAMOther

    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.

Study groups in NCT03972735
Study groupRoleWhat they receive
NECT + follow upExperimentalNarrative 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.
Receives: Other: Psychiatric interview; Other: Clinical, diagnostic and functional evaluation; Other: neuropsychological assessment; Other: NECT PROGRAM
TAUPlacebo 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)
Receives: Other: Psychiatric interview; Other: Clinical, diagnostic and functional evaluation; Other: neuropsychological assessment; Other: NECT PROGRAM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (9)

  1. Internalized Stigma of Mental Illness (ISMI) scale

    self-assessment of internalized stigma (mean score of total self-stigma ranging from 1 to 4)

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

  2. 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

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

  3. MADRS (Montgomery-Asberg Depression Rating)

    Changes in the aggregates (average) of standardized performance levels

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

  4. BIRCHWOOD INSIGHT SCALE

    Changes in the aggregates (average) of standardized performance levels

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

  5. MARS (Medication Adherence Rating Scale)

    self-assesment of adherence into treatment (minimum 1-maximum 10)

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

  6. WEMWBS (Warwick Edinburgh Mental Well Being Scale) )

    self assessment of mental well being

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

  7. 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

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

  8. S-QOL (Subjective Quality of Life)

    sel-assessment of quality of life (minimum 0, maximum 100)

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

  9. STORI Stages of Recovery Instrument

    Self-assessment of personal recovery (maximum stage of recovery ranging from 0 to 5

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start10 Feb 2020
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
stepped-wedge
Masking
Single blind
Who is masked
Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03972735
Sponsor's protocol ID
2018-A03237-48
Acronym
NECT
Status last verified
Feb 2020
First submitted
31 May 2019
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

    PubMed 11559478

  • 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.

    PubMed 20347271

  • 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.

    PubMed 19516923

  • 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.

    PubMed 23488488

  • 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.

    PubMed 19955389

  • 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.

    PubMed 21377738

  • 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.

    PubMed 16586193

  • 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.

    PubMed 16894025

  • 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.

    PubMed 16525000

  • 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.

    PubMed 17270279

  • 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.

    PubMed 19033171

  • 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.

    PubMed 21051128

  • 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.

    PubMed 27903136

  • 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.

    PubMed 24114797

  • 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.

    PubMed 33557924

Questions about this trial

What is this clinical trial studying?

A study testing Psychiatric interview, Clinical, diagnostic and functional evaluation and neuropsychological assessment in people with Schizophrenia and Bipolar Disorder, run by Hospital Center Alpes-Isère at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Julien JD DUBREUCQ, MD (+33 4 76 58 88 00, jdubreucq@ch-alpes-isere.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Personal and Social Performance Scale (time frame: Changes between baseline function, at 6, 12 and 18 months of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03972735, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

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