Mindfulness-based social cognition training (SocialMIND) versus psychoeducational multicomponent intervention for people with a first episode of psychosis: a study protocol for a randomised controlled trial

Roberto Mediavilla, Ainoa Muñoz-Sanjose, Beatriz Rodriguez-Vega, Carmen Bayon, Angela Palao, Guillermo Lahera, Pilar Sanchez-Castro, Eva Roman, Susana Cebolla, Alvaro de Diego, Juan Manuel Pastor, Maria Fe Bravo-Ortiz, Roberto Mediavilla, Ainoa Muñoz-Sanjose, Beatriz Rodriguez-Vega, Carmen Bayon, Angela Palao, Guillermo Lahera, Pilar Sanchez-Castro, Eva Roman, Susana Cebolla, Alvaro de Diego, Juan Manuel Pastor, Maria Fe Bravo-Ortiz

Abstract

Background: People who suffer a first episode of psychosis experience higher levels of distress and suffering. Early intervention programs combine pharmacological and psychosocial strategies that include different components, such as cognitive-behavioural therapy, psychosocial interventions, medication adherence, family psychoeducation, counselling, etc. Among the complementary approaches, mindfulness-based interventions help participants to cultivate a radical acceptance of their psychotic experiences within a person-centered framework. They show promising results for people with longer duration of psychosis, but there is still no evidence for people who have recently experienced their first episode of psychosis.

Methods: The present parallel-group, single-blind (evaluator), randomised (1:1 ratio), controlled (versus active comparator), superiority, clinical trial will compare the effectiveness of SocialMIND on social functioning as measured by the Personal and Social Performance (PSP) scale. The active comparator will be a psychoeducational multicomponent intervention (PMI) that incorporates elements of early intervention programs that are effective for people who have suffered a first episode of psychosis. Both SocialMIND and PMI encompass eight weekly sessions, four bi-weekly sessions, and five monthly sessions. Changes in primary and secondary outcomes will be measured after weekly (8th week), bi-weekly (16th week) and monthly sessions (56th week), and 3 months after completing the intervention (68th week). Secondary outcomes include symptoms of psychosis, anxiety and depression, as well as indicators of general functioning. Tertiary outcomes are measures of social cognition, neurocognition, mindfulness, and indicators of inflammation and oxidative stress. A final sample of 80 participants is proposed to detect clinically significant differences in social functioning.

Discussion: This is the first mindfulness-based social cognition training for people with psychosis. SocialMIND aims to generate changes in the real-life functioning of people who have experienced a first episode of psychosis, and to be at least as effective as a psychoeducational multicomponent program. Adherence to the interventions is a common problem among young people with psychosis, so several difficulties are anticipated, and some methodological issues are discussed.

Trial registration: The trial was registered in ClinicalTrials.gov in October 2018 (NCT03309475).

Keywords: Mindfulness; Psychological intervention; Psychosis; Real-life outcomes; Schizophrenia spectrum disorders; Social cognition; Social functioning.

Conflict of interest statement

The authors declare that they have no competing interests.

References

    1. Baldwin P, Browne D, Scully PJ, Quinn JF, Morgan MG, Kinsella A, et al. Epidemiology of first-episode psychosis: illustrating the challenges across diagnostic boundaries through the Cavan-Monaghan study at 8 years. Schizophr Bull. 2005;31(3):624–638. doi: 10.1093/schbul/sbi025.
    1. Welham JL, Thomis RJ, McGrath JJ. Age-at-first-registration for affective psychosis and schizophrenia. Schizophr Bull. 2004;30(4):849–853. doi: 10.1093/oxfordjournals.schbul.a007137.
    1. Lally J, Ajnakina O, Stubbs B, Cullinane M, Murphy KC, Gaughran F, et al. Remission and recovery from first-episode psychosis in adults: systematic review and meta-analysis of long-term outcome studies. Br J Psychiatry. 2017;211(6):350–358. doi: 10.1192/bjp.bp.117.201475.
    1. Leucht S, Winter-van Rossum I, Heres S, Arango C, Fleischhacker WW, Glenthøj B, et al. The optimization of treatment and management of schizophrenia in Europe (OPTiMiSE) trial: rationale for its methodology and a review of the effectiveness of switching antipsychotics. Schizophr Bull. 2015;41(3):549–558. doi: 10.1093/schbul/sbv019.
    1. Drake RJ, Nordentoft M, Haddock G, Arango C, Fleischhacker WW, Glenthøj B, et al. Modeling determinants of medication attitudes and poor adherence in early nonaffective psychosis: implications for intervention. Schizophr Bull. 2015;41(3):584–596. doi: 10.1093/schbul/sbv015.
    1. Marshall M, Rathbone J. Early intervention for psychosis. Cochrane Database Syst Rev. 2011;(6):CD004718. 10.1002/14651858.CD004718.pub3.
    1. Secher RG, Hjorthøj CR, Austin SF, Thorup A, Jeppesen P, Mors O, et al. Ten-year follow-up of the OPUS specialized early intervention trial for patients with a first episode of psychosis. Schizophr Bull. 2015;41(3):617–626. doi: 10.1093/schbul/sbu155.
    1. Ruggeri M, Bonetto C, Lasalvia A, Fioritti A, de Girolamo G, Santonastaso P, et al. Feasibility and effectiveness of a multi-element psychosocial intervention for first-episode psychosis: results from the cluster-randomized controlled GET UP PIANO trial in a catchment area of 10 million inhabitants. Schizophr Bull. 2015;41(5):1192–1203. doi: 10.1093/schbul/sbv058.
    1. Kuipers E, Holloway F, Rabe-Hesketh S, Tennakoon L. An RCT of early intervention in psychosis: Croydon outreach and assertive support team (COAST) Soc Psychiatry Psychiatr Epidemiol. 2004;39(5):358–363. doi: 10.1007/s00127-004-0754-4.
    1. Bello I, Lee R, Malinovsky I, Watkins L, Nossel I, Smith T, et al. OnTrackNY: the development of a coordinated specialty care program for individuals experiencing early psychosis. Psychiatr Serv. 2017;68(4):318–320. doi: 10.1176/appi.ps.201600512.
    1. Cotton SM, Filia KM, Ratheesh A, Pennell K, Goldstone S, McGorry PD. Early psychosis research at Orygen, the National Centre of excellence in youth mental health. Soc Psychiatry Psychiatr Epidemiol. 2016;51(1):1–13. doi: 10.1007/s00127-015-1140-0.
    1. Amos A. Assessing the cost of early intervention in psychosis: a systematic review. Aust N Z J Psychiatry. 2012;46(8):719–734. doi: 10.1177/0004867412450470.
    1. Correll CU, Galling B, Pawar A, Krivko A, Bonetto C, Ruggeri M, et al. Comparison of early intervention services vs treatment as usual for early-phase psychosis: a systematic review, meta-analysis, and meta-regression. JAMA Psychiatry. 2018;75(6):555–565. doi: 10.1001/jamapsychiatry.2018.0623.
    1. Bird V, Premkumar P, Kendall T, Whittington C, Mitchell J, Kuipers E. Early intervention services, cognitive-behavioural therapy and family intervention in early psychosis: systematic review. Br J Psychiatry. 2010;197(5):350–356. doi: 10.1192/bjp.bp.109.074526.
    1. Fleischhacker WW, Arango C, Arteel P, Barnes PRE, Carpenter W, Duckworth K, et al. Schizophrenia--time to commit to policy change. Schizophr Bull. 2014;40(suppl3):165–194. doi: 10.1093/schbul/sbu006.
    1. Guloksuz Sinan, van Os Jim. Renaming schizophrenia: 5 × 5. Epidemiology and Psychiatric Sciences. 2018;28(03):254–257. doi: 10.1017/S2045796018000586.
    1. Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: a meta-analysis. J Psychosom Res. 2015;78(6):519–528. doi: 10.1016/j.jpsychores.2015.03.009.
    1. Gotink RA, Chu P, Busschbach JJ, Benson H, Fricchione GL, Hunink MG. Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLoS One. 2015;10(4):e0124344. doi: 10.1371/journal.pone.0124344.
    1. Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, et al. Mindfulness-based interventions for psychiatric disorders: a systematic review and meta-analysis. Clin Psychol Rev. 2018;59:52–60. doi: 10.1016/j.cpr.2017.10.011.
    1. Kabat-Zinn J. Full catastrophe living: the program of the stress reduction clinic at the University of Massachusetts Medical Center. New York: Delacorte Press; 1994.
    1. Chadwick P. Mindfulness for psychosis. Br J Psychiatry. 2014;204:333–334. doi: 10.1192/bjp.bp.113.136044.
    1. MacDougall Arlene G., Price Elizabeth, Vandermeer Matthew R. J., Lloyd Chantelle, Bird Richelle, Sethi Rickinder, Shanmugalingam Aturan, Carr Jason, Anderson Kelly K., Norman Ross M. G. Youth-focused group mindfulness-based intervention in individuals with early psychosis: A randomized pilot feasibility study. Early Intervention in Psychiatry. 2018;13(4):993–998. doi: 10.1111/eip.12753.
    1. Healey KM, Bartholomeusz CF, Penn DL. Deficits in social cognition in first episode psychosis: a review of the literature. Clin Psychol Rev. 2016;50:108–137. doi: 10.1016/j.cpr.2016.10.001.
    1. Fett AK, Viechtbauer W, Dominguez MD, Penn DL, van Os J, Krabbendam L. The relationship between neurocognition and social cognition with functional outcomes in schizophrenia: a meta-analysis. Neurosci Biobehav Rev. 2011;35(3):573–588. doi: 10.1016/j.neubiorev.2010.07.001.
    1. Chan AW, Tetzlaff JM, Altman DG, Dickersin K, Moher D. SPIRIT 2013: new guidance for content of clinical trial protocols. Lancet. 2013;381(9861):91–92. doi: 10.1016/S0140-6736(12)62160-6.
    1. Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. JAMA. 2018;319(5):483–494. doi: 10.1001/jama.2017.21903.
    1. Schulz KF, Moher D, Altman DG. CONSORT 2010 comments. Lancet. 2010;376(9748):1222–1223. doi: 10.1016/S0140-6736(10)61879-X.
    1. Combs DR, Adams SD, Penn DL, Roberts D, Tiegreen J, Stem P. Social cognition and interaction training (SCIT) for inpatients with schizophrenia spectrum disorders: preliminary findings. Schizophr Res. 2007;91(1–3):112–116. doi: 10.1016/j.schres.2006.12.010.
    1. Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, et al. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992;149(7):936–943. doi: 10.1176/ajp.149.7.936.
    1. Segal ZV, Teasdale JD, Williams JM. Mindfulness-based cognitive therapy for depression. New York: The Guildford Press; 2013.
    1. Germer CK, Neff KD. Self-compassion in clinical practice. J Clin Psychol. 2013;69(8):856–867. doi: 10.1002/jclp.22021.
    1. Van Gordon W, Shonin E, Garcia-Campayo J. Are there adverse effects associated with mindfulness? Aust N Z J Psychiatry. 2017;51(10):977–979. doi: 10.1177/0004867417716309.
    1. Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV social and occupational functioning assessment scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2001;101(4):323–329. doi: 10.1034/j.1600-0447.2000.101004323.x.
    1. Garcia-Portilla MP, Saiz PA, Bousoño M, Bascaran MT, Guzmán-Quilo C, Bobes J. Validación de la versión española de la escala de Funcionamiento Personal y Social en pacientes ambulatorios con esquizofrenia estable o inestable. Rev Psiquiatr Salud Ment. 2011;4(1):9–18. doi: 10.1016/j.rpsm.2010.11.003.
    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders (4th ed., Text Revision) Washington, DC: Author; 2000.
    1. Bobes J, García-Portilla MP, Bascarán MT, Saiz PA, Bousoño M. Banco de instrumentos básicos para la práctica de la psiquiatría clínica. [CD-ROM]. 2ª Edición. [Bank of Instruments for the Clinical Practice (CD-ROM). 2nd Edition] Ars Medica: Barcelona; 2002.
    1. Mike S. C. JM, sue B. the concurrent validity of the global assessment of functioning (GAF) Br J Clin Psychol. 2010;41(4):417–422. doi: 10.1348/014466502760387533.
    1. Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261–276. doi: 10.1093/schbul/13.2.261.
    1. Kay SR, Fiszbein A, Vital-Herne M, Silva FL. The positive and negative syndrome scale – Spanish adaptation. J Nerv Ment Dis. 1990;178:510–517. doi: 10.1097/00005053-199008000-00007.
    1. Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary depression scale. Br J Psychiatry. 1993;163(Suppl. 22):39–44. doi: 10.1192/S0007125000292581.
    1. Sarró S, Dueñas RM, Ramírez N, Arranz B, Martínez R, Sánchez JM, et al. Cross-cultural adaptation and validation of the Spanish version of the Calgary depression scale for schizophrenia. Schizophr Res. 2004;68(2–3):349–356. doi: 10.1016/S0920-9964(02)00490-5.
    1. Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988;56(6):893–897. doi: 10.1037/0022-006X.56.6.893.
    1. Sanz J, Navarro ME. Propiedades psicométricas de una versión española del Inventario de Ansiedad de Beck (BAI) en estudiantes universitarios [psychometric propierties of a Spanish version of Beck anxiety inventory in university students] Ansiedad y Estrés. 2003;9:59–84.
    1. Sanz J, Garcia-Vera MP, Fortun M. El “Inventario de Ansiedad de Beck” (BAI): Propiedades psicométricas de la versión española en pacientes con trastornos psicológicos [Beck Anxiety Inventory (BAI): Psychometric properties of the Spanish versión in a simple of patients with psychological disorders] Behav Psychol. 2012;20(3):563–583.
    1. Spearing MK, Post RM, Leverich GS, Brandt D, Nolen W. Modification of the clinical global impressions (CGI) scale for use in bipolar illness (BP): the CGI-BP. Psychiatry Res. 1997;73:159–171. doi: 10.1016/S0165-1781(97)00123-6.
    1. Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating “theory of mind” in people with schizophrenia. Schizophr Res. 1995;17(1):5–13. doi: 10.1016/0920-9964(95)00024-G.
    1. Janssen I, Krabbendam L, Jolles J, Van Os J. Alterations in theory of mind in patients with schizophrenia and non-psychotic relatives. Acta Psychiatr Scand. 2003;108(2):110–117. doi: 10.1034/j.1600-0447.2003.00092.x.
    1. Baron-Cohen S, Jolliffe T, Mortimore C, Robertson M. Another advanced test of theory of mind: evidence from very high functioning adults with autism or Asperger syndrome. J Child Psychol Psychiatry. 1997;38(7):813–822. doi: 10.1111/j.1469-7610.1997.tb01599.x.
    1. Baron-Cohen S, Wheelwright S, Hill J, Raste Y, Plumb I. The “Reading the mind in the eyes” test revised version: a study with normal adults, and adults with Asperger syndrome or high-functioning autism. J Child Psychol Psychiatry Allied Discip. 2001;42(2):241–251. doi: 10.1080/13546805.2012.721728.
    1. Gil D, Fernández-Modamio M, Bengochea R, Arrieta M. Adaptation of the hinting task theory of the mind test to Spanish. Rev Psiquiatr y Salud Ment. 2012;5(2):79–88. doi: 10.1016/j.rpsmen.2011.11.002.
    1. Browne J, Penn DL, Raykov T, Pinkham AE, Kelsven S, Buck B, et al. Social cognition in schizophrenia: factor structure of emotion processing and theory of mind. Psychiatry Res. 2016;242:150–156. doi: 10.1016/j.psychres.2016.05.0341.
    1. Fernández-Abascal EG, Cabello R, Fernández-Berrocal P, Baron-Cohen S. Test-retest reliability of the “Reading the mind in the eyes” test: a one-year follow-up study. Mol Autism. 2013;4(1):2–7. doi: 10.1186/2040-2392-4-33.
    1. Kohler CG, Turner TH, Bilker WB, Brensinger CM, Siegel SJ, Kanes SJ, et al. Facial emotion recognition in schizophrenia: intensity effects and error pattern. Am J Psychiatry. 2003;160(10):1768–1774. doi: 10.1186/2040-2392-4-33.
    1. Gil-Sanz D, Fernández-Modamio M, Bengochea-Seco R, Arrieta-Rodríguez M, González-Fraile E, Pérez-Fuentes G, et al. PERE: Una nueva herramienta para valorar el reconocimiento de las emociones básicas y su aplicación en la esquizofrenia. Rev Psicopatol y Psicol Clin. 2017;22(2):85–93. doi: 10.1186/2040-2392-4-33.
    1. Combs DR, Penn DL, Wicher M, Waldheter E. The ambiguous intentions hostility questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2006;12(2):128–143. doi: 10.1080/13546800600787854.
    1. Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003;84(4):822–848. doi: 10.1037/0022-3514.84.4.822.
    1. Soler J, Tejedor R, Feliu-Soler A, Pascual JC, Cebolla A, Soriano J, et al. Psychometric proprieties of Spanish version of mindful attention awareness scale (MAAS) Actas Españolas Psiquiatr. 2012;30(1):19–26. doi: 10.1063/1.4993410.
    1. Neuctherlein KH, Green MF. MATRICS consensus cognitive battery (Spanish version) California: The Regents of the University of California; 2009.
    1. Crane RS, Eames C, Kuyken W, Hastings RP, Williams JMG, Bartley T, et al. Development and validation of the mindfulness-based interventions - teaching assessment criteria (MBI:TAC) ASMNT. 2013;20(6):681–688. doi: 10.1177/1073191113490790.
    1. Kyte D, Ives J, Draper H, Calvert M. Current practices in patient-reported outcome (PRO) data collection in clinical trials: a cross-sectional survey of UK trial staff and management. BMJ Open. 2016;6(10):e012281. doi: 10.1136/bmjopen-2016-012281.
    1. Cook JA, Julious SA, Sones W, Hampson LV, Hewitt C, Berlin JA, et al. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial Suzie Cro. Trials. 2018;19(1):1–8. doi: 10.1186/s13063-018-2884-0.
    1. May R. Relating to alternative realities. In: Romme M, Escher S, editors. Psychosis as a personal crisis: an experience-based approach. New York and London: Routledge; 2012. pp. 140–152.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する