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

J Dubreucq, M Faraldo, M Abbes, B Ycart, H Richard-Lepouriel, S Favre, F Jermann, J Attal, M Bakri, T Cohen, C Cervello, I Chereau, C Cognard, M De Clercq, A Douasbin, J Y Giordana, E Giraud-Baro, N Guillard-Bouhet, E Legros-Lafarge, M Polosan, A Pouchon, M Rolland, N Rainteau, C Roussel, C Wangermez, P T Yanos, P H Lysaker, N Franck, J Dubreucq, M Faraldo, M Abbes, B Ycart, H Richard-Lepouriel, S Favre, F Jermann, J Attal, M Bakri, T Cohen, C Cervello, I Chereau, C Cognard, M De Clercq, A Douasbin, J Y Giordana, E Giraud-Baro, N Guillard-Bouhet, E Legros-Lafarge, M Polosan, A Pouchon, M Rolland, N Rainteau, C Roussel, C Wangermez, P T Yanos, P H Lysaker, N Franck

Abstract

Background: Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning.

Methods: This is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6 months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery.

Discussion: NECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice.

Trial registration: ClinicalTrials.gov NCT03972735 . Trial registration date 31 May 2019.

Conflict of interest statement

None

Figures

Fig. 1
Fig. 1
Diagram of the stepped-wedge trial design
Fig. 2
Fig. 2
Schematic overview of the study protocol
Fig. 3
Fig. 3
Schedule of enrolment, interventions and assessments (SPIRIT diagram). BIS, Birchwood Insight Scale; ISMI, Internalized Stigma of Mental Illness; MARS, Medication Adherence Rating Scale; NECT, narrative enhancement and cognitive therapy; PSP, Personal and Social Performance Scale; S-QoL, Subjective-Quality of Life; TAU, treatment as usual; TMT, Trail Making Test; V-SIR, Versailles-Situational Intention Reading; WAIS IV, Wechsler Adult Intelligence Scale-4th edition; WEWMBS, Warwick-Edinburgh Mental Wellbeing Scale; YMRS, Young Mania Rating Scale
Fig. 4
Fig. 4
Structure of NECT topics

References

    1. Corrigan PW, Watson AC. Understanding the impact of stigma on people with mental illness. World Psychiatry. 2002;1(1):16–20.
    1. 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;122(1–3):232–238. doi: 10.1016/j.schres.2010.02.1065.
    1. Brohan E, Gauci D, Sartorius N, Thornicroft G, GAMIAN-Europe Study Group Self-stigma, empowerment and perceived discrimination among people with bipolar disorder or depression in 13 European countries: the GAMIAN-Europe study. J Affect Disord. 2011;129(1–3):56–63. doi: 10.1016/j.jad.2010.09.001.
    1. West ML, Yanos PT, Smith SM, Roe D, Lysaker PH. Prevalence of internalized stigma among persons with severe mental illness. Stigma Res Action. 2011;1(1):3–10. doi: 10.5463/sra.v1i1.9.
    1. Yanos PT, Roe D, Markus K, Lysaker PH. Pathways between internalized stigma and outcomes related to recovery in schizophrenia spectrum disorders. Psychiatr Serv. 2008;59(12):1437–1442. doi: 10.1176/ps.2008.59.12.1437.
    1. Gerlinger G, Hauser M, De Hert M, Lacluyse K, Wampers M, Correll CU. Personal stigma in schizophrenia spectrum disorders: a systematic review of prevalence rates, correlates, impact and interventions. Word Psychiatry. 2013;12:155–164. doi: 10.1002/wps.20040.
    1. Corrigan PW, Larson JE, Rüsch N. Self-stigma and the “why try” effect: impact on life goals and evidence-based practices. World Psychiatry. 2009;8:75–81. doi: 10.1002/j.2051-5545.2009.tb00218.x.
    1. Hamann J, Bühner M, Rüsch N. Self-stigma and consumer participation in shared decision making in mental health services. Psychiatr Serv. 2017;68(8):783–788. doi: 10.1176/appi.ps.201600282.
    1. Hill K, Startup M. The relationship between internalized stigma, negative symptoms and social functioning in schizophrenia: the mediating role of self-efficacy. Psychiatry Res. 2013;206(2–3):151–157. doi: 10.1016/j.psychres.2012.09.056.
    1. Cerit C, Filizer A, Tural Ü, Tufan AE. Stigma: a core factor on predicting functionality in bipolar disorder. Compr Psychiatry. 2012;53(5):484–489. doi: 10.1016/j.comppsych.2011.08.010.
    1. Mersh L, Jones F, Oliver J. Mindfulness, self-stigma and social functioning in first episode psychosis: a brief report. Psychosis. 2015;7(3):1–4. doi: 10.1080/17522439.2015.1024714.
    1. Firmin RL, Lysaker PH, Luther L, Yanos PT, Leonhardt B, Breier A, et al. Internalized stigma in adults with early phase versus prolonged psychosis. Early Interv Psychiatry. 2019;13(4):745–751. doi: 10.1111/eip.12553.
    1. Xu Z, Lay B, Oexle N, Drack T, Bleiker M, Lengler S, et al. Involuntary psychiatric hospitalisation, stigma stress and recovery: a 2-year study. Epidemiol Psychiatr Sci. 2018;31:1–8.
    1. Oexle N, Müller M, Kawohl W, Xu Z, Viering S, Wyss C, et al. Self-stigma as a barrier to recovery: a longitudinal study. Eur Arch Psychiatry Clin Neurosci. 2018;268(2):209–212. doi: 10.1007/s00406-017-0773-2.
    1. Schrank B, Amering M, Hay AG, Weber M, Sibitz I. Insight, positive and negative symptoms, hope, depression and self-stigma: a comprehensive model of mutual influences in schizophrenia spectrum disorders. Epidemiol Psychiatr Sci. 2014;23(3):271–279. doi: 10.1017/S2045796013000322.
    1. Park SG, Bennett ME, Couture SM, Blanchard JJ. Internalized stigma in schizophrenia: relations with dysfunctional attitudes, symptoms, and quality of life. Psychiatry Res. 2013;205(1–2):43–47. doi: 10.1016/j.psychres.2012.08.040.
    1. Valiente C, Provencio M, Espinosa R, Duque A, Everts F. Insight in paranoia: the role of experiential avoidance and internalized stigma. Schizophr Res. 2015;164(1–3):214–220. doi: 10.1016/j.schres.2015.03.010.
    1. Oexle N, Rüsch N, Viering S, Wyss C, Seifritz E, Xu Z, et al. Self-stigma and suicidality: a longitudinal study. Eur Arch Psychiatry Clin Neurosci. 2017;267(4):359–361. doi: 10.1007/s00406-016-0698-1.
    1. Oexle N, Waldmann T, Staiger T, Xu Z, Rüsch N. Mental illness stigma and suicidality: the role of public and individual stigma. Epidemiol Psychiatr Sci. 2018;27:169–175. doi: 10.1017/S2045796016000949.
    1. Espinosa R, Valiente C, Rigabert A, Song H. Recovery style and stigma in psychosis: the healing power of integrating. Cogn Neuropsychiatry. 2016;21(2):146–155. doi: 10.1080/13546805.2016.1147427.
    1. Au CH, Wong CS, Law CW, Wong MC, Chung KF. Self-stigma, stigma coping and functioning in remitted bipolar disorder. Gen Hosp Psychiatry. 2019;57:7–12. doi: 10.1016/j.genhosppsych.2018.12.007.
    1. Cavelti M, Kvrgic S, Beck EM, Rüsch N, Vauth R. Self-stigma and its relationship with insight, demoralization, and clinical outcome among people with schizophrenia spectrum disorders. Compr Psychiatry. 2012;53(5):468–479. doi: 10.1016/j.comppsych.2011.08.001.
    1. 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;33(1):192–199. doi: 10.1093/schbul/sbl016.
    1. Lysaker PH, Vohs J, Hasson-Ohayon I, Kukla M, Wierwille J, Dimaggio G. Depression and insight in schizophrenia: comparisons of levels of deficits in social cognition and metacognition and internalized stigma across three profiles. Schizophr Res. 2013;148(1–3):18–23. doi: 10.1016/j.schres.2013.05.025.
    1. Lysaker PH, Buck KD, Taylor AC, Roe D. Associations of metacognition and internalized stigma with quantitative assessments of self-experience in narratives of schizophrenia. Psychiatry Res. 2008;157(1–3):31–38. doi: 10.1016/j.psychres.2007.04.023.
    1. Lysaker PH, Vohs JL, Tsai J. Negative symptoms and concordant impairments in attention in schizophrenia: associations with social functioning, hope, self-esteem and internalized stigma. Schizophr Res. 2009;110(1–3):165–172. doi: 10.1016/j.schres.2009.01.015.
    1. Galderisi S, Rossi A, Rocca P, Bertolino A, Mucci A, Bucci P, et al. The influence of illness-related variables, personal resources and context-related factors on real-life functioning of people with schizophrenia. World Psychiatry. 2014;13(3):275–287. doi: 10.1002/wps.20167.
    1. Hasson-Ohayon I, Mashiach-Eizenberg M, Elhasid N, Yanos PT, Lysaker PH, Roe D. Between self-clarity and recovery in schizophrenia: reducing the self-stigma and finding meaning. Compr Psychiatry. 2014;55(3):675–680. doi: 10.1016/j.comppsych.2013.11.009.
    1. Hasson-Ohayon I, Mashiach-Eizenberg M, Lysaker PH, Roe D. Self-clarity and different clusters of insight and self-stigma in mental illness. Psychiatry Res. 2016;240:308–313. doi: 10.1016/j.psychres.2016.04.060.
    1. Wood L, Byrne R, Burke E, Enache G, Morrison AP. The impact of stigma on emotional distress and recovery from psychosis: the mediatory role of internalised shame and self-esteem. Psychiatry Res. 2017;255:94–100. doi: 10.1016/j.psychres.2017.05.016.
    1. Yanos PT, Lysaker PH, Roe D. Internalized stigma as a barrier to improvement in vocational functioning among people with schizophrenia-spectrum disorders. Psychiatry Res. 2010;178(1):211–213. doi: 10.1016/j.psychres.2010.01.003.
    1. 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;70(4):303–312. doi: 10.1002/jclp.22050.
    1. Hansson L, Lexén A, Holmén J. The effectiveness of narrative enhancement and cognitive therapy: a randomized controlled study of a self-stigma intervention. Soc Psychiatry Psychiatr Epidemiol. 2017;52(11):1415–1423. doi: 10.1007/s00127-017-1385-x.
    1. Yanos PT, Lysaker PH, Silverstein SM, Vayshenker B, Gonzales L, West ML, et al. A randomized-controlled trial of treatment for self-stigma among persons diagnosed with schizophrenia-spectrum disorders. Soc Psychiatry Psychiatr Epidemiol. 2019. 10.1007/s00127-019-01702-0.
    1. Heinrichs DW, Hanlon TE, Carpenter WT. The quality of life scale: an instrument for assessing the schizophrenic deficit syndrome. Schizophr Bull. 1984;10:388–396. doi: 10.1093/schbul/10.3.388.
    1. Franck N, Bon L, Dekerle M, Plasse J, Massoubre C, Pommier R, et al. Satisfaction and needs in serious mental illness and autism spectrum disorder: the REHABase psychosocial rehabilitation project. Psychiatr Serv. 2019;70(4):316–323. doi: 10.1176/appi.ps.201800420.
    1. Dubreucq J, Plasse J, Gabayet F, Faraldo M (…) REHABase network and Franck N. Self-stigma in serious mental illness and autism spectrum disorder: results from the REHABase national psychiatric rehabilitation cohort. Eur Psychiatry. Accepted for publication.
    1. Dubreucq J, Plasse J, Franck N. Self-stigma in Serious Mental Illness: A Systematic Review of Frequency, Correlates, and Consequences, Schizophrenia Bulletin. 2021;sbaa181. 10.1093/schbul/sbaa181.
    1. Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015;350 Available from: . [cited 2019 Jul 17].
    1. Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, et al. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. . Accessed 18 July 2019.
    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) 5. Washington: DC Author; 2013.
    1. Schürhoff F, Fond G, Berna F, Bulzacka E, Vilain J, Capde-vielle D, et al. A national network of schizophrenia expert centres: an innovative tool to bridge the research-practice gap. Eur Psychiatry. 2015;30(6):728–735. doi: 10.1016/j.eurpsy.2015.05.004.
    1. Henry C, Etain B, Mathieu F, Raust A, Vibert JF, Scott J, et al. A French network of bipolar expert centres: a model to close the gap between evidence-based medicine and routine practice. J Affect Disord. 2011;131(1–3):358–363. doi: 10.1016/j.jad.2010.11.013.
    1. Nasrallah H, Morosini PL, Gagnon DD. Reliability, validity and ability to detect change of the Personal and Social Performance Scale in patients with stable schizophrenia. Psychiatry Res. 2008;161:213–224. doi: 10.1016/j.psychres.2007.11.012.
    1. Champely S. pwr: Basic functions for power analysis [Computer software] (version 1.2-2); 2018. Retrieved from .
    1. Cohen J. Statistical power analysis for the behavioral sciences. 2. Hillsdale, NJ: Lawrence Erlbaum; 1988.
    1. Hemming K, Taljaard M. Sample size calculations for stepped wedge and cluster randomised trials: a unified approach. J Clin Epidemiol. 2016;69:137–146. doi: 10.1016/j.jclinepi.2015.08.015.
    1. Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. Int J Epidemiol. 2020;49(3):979–995. doi: 10.1093/ije/dyz237.
    1. Dixon LB, Dickerson F, Bellack AS, Bennett M, Dickinson D, Goldberg RW, et al. The 2009 schizophrenia PORT psychosocial treatment recommendations and summary statements. Schizophr Bull. 2010;36(1):48–70. doi: 10.1093/schbul/sbp115.
    1. Vieta E, Berk M, Schulze TG, Carvalho AF, Suppes T, Calabrese JR, et al. Bipolar disorders. Nat Rev Dis Primers. 2018;4:18008. doi: 10.1038/nrdp.2018.8.
    1. Gunderson JG, Herpertz SC, Skodol AE, Torgersen S, Zanarini MC. Borderline personality disorder. Nat Rev Dis Primers. 2018;4:18029. doi: 10.1038/nrdp.2018.29.
    1. Kawata AK, Revicki DA. Psychometric properties of the Personal and Social Performance scale (PSP) among individuals with schizophrenia living in the -community. Qual Life Res. 2008;17(10):1247–1256. doi: 10.1007/s11136-008-9400-z.
    1. Patrick DC, Burns T, Morosini P, Rothman M, Gagnon DD, Wild D, et al. Reliability, validity and ability to detect change of the clinician-rated Personal and Social Performance scale in patients with acute symptoms of schizophrenia. Curr Med Res Opin. 2009;25(2):325–335. doi: 10.1185/03007990802611919.
    1. Boyd Ritsher J, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003;121:31–49. doi: 10.1016/j.psychres.2003.08.008.
    1. Kay S, Fiszbein A, Opler L. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261–276. doi: 10.1093/schbul/13.2.261.
    1. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Brit J Psychiatry. 1979;134:382–389. doi: 10.1192/bjp.134.4.382.
    1. Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133:429–435. doi: 10.1192/bjp.133.5.429.
    1. Birchwood M, Smith J, Drury V, Healy J, Macmillan F, Slade M. A self-report insight scale for psychosis: reliability, validity and sensitivity to change. Acta Psychiatr Scand. 1994;89(1):62–67. doi: 10.1111/j.1600-0447.1994.tb01487.x.
    1. Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res. 2000;42(3):241–247. doi: 10.1016/S0920-9964(99)00130-9.
    1. Auquier P, Simeoni MC, Sapin C, Reine G, Aghababian V, Cramer J, et al. Development and validation of a patient-based health-related quality of life questionnaire in schizophrenia: the S-QoL. Schizophr Res. 2003;63(1–2):137–149. doi: 10.1016/S0920-9964(02)00355-9.
    1. Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, et al. The Warwick-Edinburgh Mental Well-being Scale 19 (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007;5:63. doi: 10.1186/1477-7525-5-63.
    1. Lecomte T, Corbière M, Laisné F. Investigating self-esteem in individuals with schizophrenia: relevance of the Self-Esteem Rating Scale-Short Form. Psychiatry Res. 2006;143(1):99–108. doi: 10.1016/j.psychres.2005.08.019.
    1. Andresen R, Caputi P, Oades LG. Stages of recovery instrument: development of a measure of recovery from serious mental illness. Aust NZ J Psychiatry. 2006;40:972–980. doi: 10.1080/j.1440-1614.2006.01921.x.
    1. Wechsler D. WAIS IV Nouvelle version de l’échelle d’intelligence de Weschler pour adultes. 4. Paris: Edition de Centre de Psychologie Appliquée; 2011.
    1. Signoret JL. Batterie d’efficience mnésique BEM 144. Paris: Elsevier; 1991.
    1. Godefroy O, GREFEX (Groupe de Réflexion pour l’Evaluation des Fonctions Exécutives). Fonctions exécutives et pathologies neurologiques et 675 psychiatriques. Evaluation en pratique clinique. Marseille: DeBoeck supérieur; 2012:84.
    1. Brickenkamp R, Schmidt-Atzert L, Liepmann D. D2-R : Test d’attention concentrée révisé. Paris: Editions Hogrefe; 2015.
    1. Pelletier Y, Lemoine L, Gros C, Fournet N. Test des commissions révisé. GREMOIRE II Tests et échelles des maladies neurologiques avec symptomatologie cognitive. Paris: De Boeck-Solal; 2009.
    1. Bazin N, Brunet-Gouet E, Bourdet C, Kayser N, Falissard B, Hardy-Baylé MC, et al. Quantitative assessment of attribution of intentions to others in schizophrenia using an ecological video-based task: a comparison with manic and depressed patients. Psychiatry Res. 2009;167:28–35. doi: 10.1016/j.psychres.2007.12.010.
    1. R Core Team. R: a language and environment for statistical computing, R Foundation for Statistical Computing, Vienna, Austria, 2015. . Accessed 18 July 2019.
    1. Revelle W. Psych: procedures for psychological, psychometric, and personality research, Northwestern University. Evanston, Illinois: R package; 2015.
    1. Lumley T. Leaps: regression subset selection. 2009. . Accessed 18 July 2019.

Source: PubMed

3
Abonnere